<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03815175</url>
  </required_header>
  <id_info>
    <org_study_id>ABT-CIP-10402</org_study_id>
    <nct_id>NCT03815175</nct_id>
  </id_info>
  <brief_title>XIENCE 28 USA Study</brief_title>
  <official_title>XIENCE 28 USA Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized&#xD;
      trial to evaluate safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in&#xD;
      subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI)&#xD;
      with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System&#xD;
      [EECSS], XIENCE Alpine EECSS and XIENCE Sierra EECSS) of coronary drug-eluting stents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The XIENCE 28 USA Study will evaluate the safety of 1-month DAPT following XIENCE&#xD;
      implantation in HBR patients. A minimum of 640 to a maximum of 800 subjects will be&#xD;
      registered from approximately 50 sites in the United States and Canada. Subject registration&#xD;
      is capped at 75 per site. Eligibility of P2Y12 receptor inhibitor discontinuation will be&#xD;
      assessed at 1-month follow-up. Subjects who are free from myocardial infarction (MI), repeat&#xD;
      coronary revascularization, stroke, or stent thrombosis (ARC definite/probable) within 1&#xD;
      month (prior to 1-month visit but at least 28 days) after stenting AND have been compliant&#xD;
      with 1-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for&#xD;
      &gt; 7 consecutive days are considered as &quot;1-month clear&quot;, and will discontinue P2Y12 receptor&#xD;
      inhibitor as early as 28 days and continued with aspirin monotherapy through 12-month&#xD;
      follow-up.&#xD;
&#xD;
      All registered subjects will be followed at 1, 3, 6 and 12 months post index procedure. The&#xD;
      data collected from the XIENCE 28 USA Study will be pooled with the data from the XIENCE 28&#xD;
      Global Study (Protocol # ABT-CIP-10235) to compare with the historical control of non-complex&#xD;
      HBR subjects treated with standard DAPT duration of up to 12 months from the XIENCE V USA&#xD;
      Study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2019</start_date>
  <completion_date type="Actual">February 4, 2021</completion_date>
  <primary_completion_date type="Actual">August 14, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile</measure>
    <time_frame>From 1 to 6 months</time_frame>
    <description>All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.&#xD;
MI Definition (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Peripheral MI&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile</measure>
    <time_frame>From 6 to 12 months</time_frame>
    <description>All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.&#xD;
MI Definition (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Peripheral MI&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile</measure>
    <time_frame>From 1 to 12 months</time_frame>
    <description>All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.&#xD;
MI Definition (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Peripheral MI&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Major Bleeding Rate (Bleeding Academic Research Consortium [BARC] Type 2-5), by Propensity Score Quintiles</measure>
    <time_frame>From 1 to 6 months</time_frame>
    <description>Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:&#xD;
Type 2: Any overt, actionable sign of hemorrhage&#xD;
Type 3a: Overt bleeding plus Hb drop of 3 to &lt; 5g/dL;Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision&#xD;
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period&#xD;
Type 5: Fatal bleeding&#xD;
Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious&#xD;
Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles</measure>
    <time_frame>From 6 to 12 months</time_frame>
    <description>Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:&#xD;
Type 2: Any overt, actionable sign of hemorrhage&#xD;
Type 3a: Overt bleeding plus Hb drop of 3 to &lt; 5g/dL;Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision&#xD;
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period&#xD;
Type 5: Fatal bleeding&#xD;
Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious&#xD;
Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles</measure>
    <time_frame>From 1 to 12 months</time_frame>
    <description>Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:&#xD;
Type 2: Any overt, actionable sign of hemorrhage&#xD;
Type 3a: Overt bleeding plus Hb drop of 3 to &lt; 5g/dL;Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision&#xD;
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period&#xD;
Type 5: Fatal bleeding&#xD;
Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious&#xD;
Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)</measure>
    <time_frame>From 1 to 6 months</time_frame>
    <description>Definite stent thrombosis:&#xD;
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.&#xD;
Probable stent thrombosis:&#xD;
Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:&#xD;
Any unexplained death within the first 30 days&#xD;
Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)</measure>
    <time_frame>From 6 to 12 months</time_frame>
    <description>Definite stent thrombosis:&#xD;
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.&#xD;
Probable stent thrombosis:&#xD;
Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:&#xD;
Any unexplained death within the first 30 days&#xD;
Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)</measure>
    <time_frame>From 1 to 12 months</time_frame>
    <description>Definite stent thrombosis:&#xD;
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.&#xD;
Probable stent thrombosis:&#xD;
Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:&#xD;
Any unexplained death within the first 30 days&#xD;
Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)</measure>
    <time_frame>From 1 to 6 months</time_frame>
    <description>All Death:&#xD;
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.&#xD;
Cardiac death:&#xD;
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.&#xD;
Vascular death:&#xD;
Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.&#xD;
Non-cardiovascular death:&#xD;
Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)</measure>
    <time_frame>From 6 to 12 months</time_frame>
    <description>All Death:&#xD;
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.&#xD;
Cardiac death:&#xD;
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.&#xD;
Vascular death:&#xD;
Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.&#xD;
Non-cardiovascular death:&#xD;
Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)</measure>
    <time_frame>From 1 to 12 months</time_frame>
    <description>All Death:&#xD;
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.&#xD;
Cardiac death:&#xD;
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.&#xD;
Vascular death:&#xD;
Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.&#xD;
Non-cardiovascular death:&#xD;
Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)</measure>
    <time_frame>From 1 to 6 months</time_frame>
    <description>All Myocardial Infarction (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI:&#xD;
Within 48h after PCI: CK-MB &gt;3 x URL or Troponin &gt; 3 x URL with baseline value &lt; URL&#xD;
Within 72h after CABG: CK-MB &gt;5 x URL or Troponin &gt; 5 x URL with baseline value &lt; URL&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL&#xD;
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC)</measure>
    <time_frame>From 6 to 12 months</time_frame>
    <description>All Myocardial Infarction (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI:&#xD;
Within 48h after PCI: CK-MB &gt;3 x URL or Troponin &gt; 3 x URL with baseline value &lt; URL&#xD;
Within 72h after CABG: CK-MB &gt;5 x URL or Troponin &gt; 5 x URL with baseline value &lt; URL&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL&#xD;
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC)</measure>
    <time_frame>From 1 to 12 months</time_frame>
    <description>All Myocardial Infarction (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI:&#xD;
Within 48h after PCI: CK-MB &gt;3 x URL or Troponin &gt; 3 x URL with baseline value &lt; URL&#xD;
Within 72h after CABG: CK-MB &gt;5 x URL or Troponin &gt; 5 x URL with baseline value &lt; URL&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL&#xD;
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Composite of Cardiac Death or MI (Modified ARC)</measure>
    <time_frame>From 1 to 6 months</time_frame>
    <description>Cardiac death:&#xD;
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.&#xD;
MI (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI:&#xD;
Within 48h after PCI: CK-MB &gt;3 x URL or Troponin &gt; 3 x URLwith baseline value &lt; URL&#xD;
Within 72h after CABG: CK-MB &gt;5 x URL or Troponin &gt; 5 x URL with baseline value &lt; URL&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Composite of Cardiac Death or MI (Modified ARC)</measure>
    <time_frame>From 6 to 12 months</time_frame>
    <description>Cardiac death:&#xD;
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.&#xD;
MI (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI:&#xD;
Within 48h after PCI: CK-MB &gt;3 x URL or Troponin &gt; 3 x URLwith baseline value &lt; URL&#xD;
Within 72h after CABG: CK-MB &gt;5 x URL or Troponin &gt; 5 x URL with baseline value &lt; URL&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Composite of Cardiac Death or MI (Modified ARC)</measure>
    <time_frame>From 1 to 12 months</time_frame>
    <description>Cardiac death:&#xD;
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.&#xD;
MI (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI:&#xD;
Within 48h after PCI: CK-MB &gt;3 x URL or Troponin &gt; 3 x URLwith baseline value &lt; URL&#xD;
Within 72h after CABG: CK-MB &gt;5 x URL or Troponin &gt; 5 x URL with baseline value &lt; URL&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Composite of All Death or All MI (Modified ARC)</measure>
    <time_frame>From 1 to 6 months</time_frame>
    <description>All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.&#xD;
MI (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Composite of All Death or All MI (Modified ARC)</measure>
    <time_frame>From 6 to 12 months</time_frame>
    <description>All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.&#xD;
MI (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Composite of All Death or All MI (Modified ARC)</measure>
    <time_frame>From 1 to 12 months</time_frame>
    <description>All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.&#xD;
MI (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)</measure>
    <time_frame>From 1 to 6 months</time_frame>
    <description>An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.&#xD;
Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.&#xD;
Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.&#xD;
Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.&#xD;
Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)</measure>
    <time_frame>From 6 to 12 months</time_frame>
    <description>An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.&#xD;
Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.&#xD;
Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.&#xD;
Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.&#xD;
Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)</measure>
    <time_frame>From 1 to 12 months</time_frame>
    <description>An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.&#xD;
Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.&#xD;
Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.&#xD;
Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.&#xD;
Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)</measure>
    <time_frame>From 1 to 6 months</time_frame>
    <description>Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.&#xD;
Clinically Indicated [CI] Revascularization:&#xD;
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:&#xD;
A positive history of recurrent angina pectoris, presumably related to the target vessel;&#xD;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;&#xD;
Abnormal results of any invasive functional diagnostic test&#xD;
A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With CI-TLR</measure>
    <time_frame>From 6 to 12 months</time_frame>
    <description>Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.&#xD;
Clinically Indicated [CI] Revascularization:&#xD;
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:&#xD;
A positive history of recurrent angina pectoris, presumably related to the target vessel;&#xD;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;&#xD;
Abnormal results of any invasive functional diagnostic test&#xD;
A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With CI-TLR</measure>
    <time_frame>From 1 to 12 months</time_frame>
    <description>Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.&#xD;
Clinically Indicated [CI] Revascularization:&#xD;
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:&#xD;
A positive history of recurrent angina pectoris, presumably related to the target vessel;&#xD;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;&#xD;
Abnormal results of any invasive functional diagnostic test&#xD;
A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)</measure>
    <time_frame>From 1 to 6 months</time_frame>
    <description>TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.&#xD;
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:&#xD;
A positive history of recurrent angina pectoris, presumably related to the target vessel;&#xD;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;&#xD;
Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);&#xD;
A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With CI-TVR</measure>
    <time_frame>From 6 to 12 months</time_frame>
    <description>TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.&#xD;
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:&#xD;
A positive history of recurrent angina pectoris, presumably related to the target vessel;&#xD;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;&#xD;
Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);&#xD;
A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With CI-TVR</measure>
    <time_frame>From 1 to 12 months</time_frame>
    <description>TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.&#xD;
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:&#xD;
A positive history of recurrent angina pectoris, presumably related to the target vessel;&#xD;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;&#xD;
Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);&#xD;
A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)</measure>
    <time_frame>From 1 to 6 months</time_frame>
    <description>TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)</measure>
    <time_frame>From 6 to 12 months</time_frame>
    <description>TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)</measure>
    <time_frame>From 1 to 12 months</time_frame>
    <description>TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)</measure>
    <time_frame>From 1 to 6 months</time_frame>
    <description>TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)</measure>
    <time_frame>From 6 to 12 months</time_frame>
    <description>TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)</measure>
    <time_frame>From 1 to 12 months</time_frame>
    <description>TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5</measure>
    <time_frame>From 1 to 6 months</time_frame>
    <description>Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:&#xD;
Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to &lt; 5 g/dL; Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision&#xD;
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period&#xD;
Type 5: Fatal bleeding&#xD;
Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious&#xD;
Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5</measure>
    <time_frame>From 6 to 12 months</time_frame>
    <description>Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:&#xD;
Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to &lt; 5 g/dL; Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision&#xD;
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period&#xD;
Type 5: Fatal bleeding&#xD;
Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious&#xD;
Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5</measure>
    <time_frame>From 1 to 12 months</time_frame>
    <description>Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:&#xD;
Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to &lt; 5 g/dL; Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision&#xD;
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period&#xD;
Type 5: Fatal bleeding&#xD;
Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious&#xD;
Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1605</enrollment>
  <condition>Bleeding Disorder</condition>
  <condition>Ischemic Stroke</condition>
  <condition>Hemorrhagic Stroke</condition>
  <condition>Hematological Diseases</condition>
  <condition>Thrombocytopenia</condition>
  <condition>Coagulation Disorder</condition>
  <condition>Anemia</condition>
  <condition>Renal Insufficiency</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>XIENCE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>XIENCE + 1 month DAPT</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>XIENCE</intervention_name>
    <description>Subjects who received XIENCE family stent systems will be included.</description>
    <arm_group_label>XIENCE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DAPT (aspirin and/or P2Y12 receptor inhibitor)</intervention_name>
    <description>&quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
    <arm_group_label>XIENCE</arm_group_label>
    <other_name>Dual antiplatelet therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is considered at high risk for bleeding (HBR), defined as meeting one or more&#xD;
             of the following criteria at the time of registration and in the opinion of the&#xD;
             referring physician, the risk of major bleeding with &gt; 1-month DAPT outweighs the&#xD;
             benefit:&#xD;
&#xD;
               1. ≥ 75 years of age.&#xD;
&#xD;
               2. Clinical indication for chronic (at least 6 months) or lifelong anticoagulation&#xD;
                  therapy&#xD;
&#xD;
               3. History of major bleeding which required medical attention within 12 months of&#xD;
                  the index procedure.&#xD;
&#xD;
               4. History of stroke (ischemic or hemorrhagic).&#xD;
&#xD;
               5. Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent).&#xD;
&#xD;
               6. Systemic conditions associated with an increased bleeding risk (e.g.&#xD;
                  hematological disorders, including a history of or current thrombocytopenia&#xD;
                  defined as a platelet count &lt;100,000/mm3, or any known coagulation disorder&#xD;
                  associated with increased bleeding risk).&#xD;
&#xD;
               7. Anemia with hemoglobin &lt; 11g/dl.&#xD;
&#xD;
          2. Subject must be at least 18 years of age.&#xD;
&#xD;
          3. Subject must provide written informed consent as approved by the Institutional Review&#xD;
             Board (IRB) of the respective clinical site prior to any trial related procedure.&#xD;
&#xD;
          4. Subject is willing to comply with all protocol requirements, including agreement to&#xD;
             stop taking P2Y12 inhibitor at 1 month, if eligible per protocol.&#xD;
&#xD;
          5. Subject must agree not to participate in any other clinical trial for a period of one&#xD;
             year following the index procedure, except for cases where subject is transferred to&#xD;
             the XIENCE 90 study after the 1-month visit assessment&#xD;
&#xD;
        Angiographic Inclusion Criteria&#xD;
&#xD;
          1. Up to three target lesions with a maximum of two target lesions per epicardial vessel.&#xD;
             Note:&#xD;
&#xD;
               -  The definition of epicardial vessels means left anterior descending coronary&#xD;
                  artery (LAD), left circumflex coronary artery (LCX) and right coronary artery&#xD;
                  (RCA) and their branches. For example, the subject must not have &gt;2 lesions&#xD;
                  requiring treatment within both the LAD and a diagonal branch in total.&#xD;
&#xD;
               -  If there are two target lesions within the same epicardial vessel, the two target&#xD;
                  lesions must be at least 15 mm apart per visual estimation; otherwise this is&#xD;
                  considered as a single target lesion.&#xD;
&#xD;
          2. Target lesion must be located in a native coronary artery with visually estimated&#xD;
             reference vessel diameter between 2.25 mm and 4.25 mm.&#xD;
&#xD;
          3. Exclusive use of XIENCE family of stent systems during the index procedure.&#xD;
&#xD;
          4. Target lesion has been treated successfully, which is defined as achievement of a&#xD;
             final in-stent residual diameter stenosis of &lt;20% with final TIMI-3 flow assessed by&#xD;
             online quantitative angiography or visual estimation, with no residual dissection&#xD;
             NHLBI grade ≥ type B, and no transient or sustained angiographic complications (e.g.,&#xD;
             distal embolization, side branch closure), no chest pain lasting &gt; 5 minutes, and no&#xD;
             ST segment elevation &gt; 0.5mm or depression lasting &gt; 5 minutes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject with an indication for the index procedure of acute ST-segment elevation MI&#xD;
             (STEMI).&#xD;
&#xD;
          2. Subject has a known hypersensitivity or contraindication to aspirin,&#xD;
             heparin/bivalirudin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), everolimus,&#xD;
             cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast&#xD;
             sensitivity that cannot be adequately pre-medicated.&#xD;
&#xD;
          3. Subject with implantation of another drug-eluting stent (other than XIENCE) within 12&#xD;
             months prior to index procedure.&#xD;
&#xD;
          4. Subject has a known left ventricular ejection fraction (LVEF) &lt;30%.&#xD;
&#xD;
          5. Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor&#xD;
             use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use.&#xD;
&#xD;
          6. Subject with planned surgery or procedure necessitating discontinuation of P2Y12&#xD;
             inhibitor within 1 month following index procedure.&#xD;
&#xD;
          7. Subject with a current medical condition with a life expectancy of less than 12&#xD;
             months.&#xD;
&#xD;
          8. Subject intends to participate in an investigational drug or device trial within 12&#xD;
             months following the index procedure. Transferring to the XIENCE 90 study will not be&#xD;
             an exclusion criterion.&#xD;
&#xD;
          9. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year&#xD;
             following index procedure. Female subjects of child-bearing potential must have a&#xD;
             negative pregnancy test done within 7 days prior to the index procedure per site&#xD;
             standard test.&#xD;
&#xD;
         10. Presence of other anatomic or comorbid conditions, or other medical, social, or&#xD;
             psychological conditions that, in the investigator's opinion, could limit the&#xD;
             subject's ability to participate in the clinical investigation or to comply with&#xD;
             follow-up requirements, or impact the scientific soundness of the clinical&#xD;
             investigation results.&#xD;
&#xD;
         11. Subject is currently participating in another clinical trial that has not yet&#xD;
             completed its primary endpoint.&#xD;
&#xD;
        Angiographic Exclusion Criteria&#xD;
&#xD;
          1. Target lesion is in a left main location.&#xD;
&#xD;
          2. Target lesion is located within an arterial or saphenous vein graft.&#xD;
&#xD;
          3. Target lesion is restenotic from a previous stent implantation.&#xD;
&#xD;
          4. Target lesion is a chronic total occlusion (CTO, defined as lesion with TIMI flow 0&#xD;
             for at least 3 months).&#xD;
&#xD;
          5. Target lesion is implanted with overlapping stents, whether planned or for bailout.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roxana Mehran, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mount Sinai Medical Center,New York, NY</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart Center Research, LLC</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phoenix Cardiovascular Research Group</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scottsdale Healthcare Shea</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NEA Baptist Clinic</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Heart Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mission Cardiovascular Research Institute</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scripps Memorial Hospital - La Jolla</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntington Memorial Hospital</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Barbara Cottage Hospital</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente - Santa Clara</name>
      <address>
        <city>Santa Clara</city>
        <state>California</state>
        <zip>95051</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates of Fairfield County, PC</name>
      <address>
        <city>Norwalk</city>
        <state>Connecticut</state>
        <zip>06851</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clearwater Cardiovascular Consultants</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morton Plant Hospital</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tallahassee Research Institute</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Georgia Medical Center</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Redmond Regional Medical Center</name>
      <address>
        <city>Rome</city>
        <state>Georgia</state>
        <zip>30165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Via Christi Regional Medical Center - St. Francis Campus</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214-3882</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Research Institute of Kansas</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Maine Medical Center</name>
      <address>
        <city>Bangor</city>
        <state>Maine</state>
        <zip>04401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Memorial Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Isreal Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLaren Health Care Corporation</name>
      <address>
        <city>Auburn Hills</city>
        <state>Michigan</state>
        <zip>48326</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Munson Medical Center</name>
      <address>
        <city>Traverse City</city>
        <state>Michigan</state>
        <zip>49684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis Heart Institute</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jackson Heart Clinic</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Missouri Heart Center</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jersey Shore University Medical Center</name>
      <address>
        <city>Neptune</city>
        <state>New Jersey</state>
        <zip>07753</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lenox Hill Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Hospital Health Center</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novant Health Heart and Vascular Research Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cone Health Medical Group Heartcare</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NC Heart &amp; Vascular Research</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Medical Center Clinical Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157- 1045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kettering Medical Center</name>
      <address>
        <city>Kettering</city>
        <state>Ohio</state>
        <zip>45429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent Mercy Medical Center</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Hamot</name>
      <address>
        <city>Erie</city>
        <state>Pennsylvania</state>
        <zip>16550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pinnacle Health System</name>
      <address>
        <city>Harrisburg</city>
        <state>Pennsylvania</state>
        <zip>17105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presbyterian Medical Center (PA)</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph Medical Center</name>
      <address>
        <city>Reading</city>
        <state>Pennsylvania</state>
        <zip>19605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anmed Health</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford USD Medical Center</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Tennessee Heart Consultants</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centennial Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Heart</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott and White Heart and Vascular Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mission Research Institute</name>
      <address>
        <city>New Braunfels</city>
        <state>Texas</state>
        <zip>78130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HeartPlace Methodist Richardson</name>
      <address>
        <city>Richardson</city>
        <state>Texas</state>
        <zip>75082</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Texas Medical Center</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Washington Hospital</name>
      <address>
        <city>Fredericksburg</city>
        <state>Virginia</state>
        <zip>22401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charleston Area Medical Center</name>
      <address>
        <city>Charleston</city>
        <state>West Virginia</state>
        <zip>25304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kepler Universitätsklinikum GmbH</name>
      <address>
        <city>Linz</city>
        <state>Upr Aus</state>
        <zip>4021</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onze-Lieve-Vrouwziekenhuis Campus Aalst</name>
      <address>
        <city>Aalst</city>
        <state>Eflndrs</state>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <state>Flemish</state>
        <zip>42100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Oost-Limburg</name>
      <address>
        <city>Genk</city>
        <state>Limburg</state>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jesse Ziekenhuis Campus Virga Jesse</name>
      <address>
        <city>Limbourg</city>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foothills Medical Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Jubilee Hospital</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8R 1J8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint John Regional Hospital - New Brunswick Heart Centre</name>
      <address>
        <city>Saint John</city>
        <state>New Brunswick</state>
        <zip>E2L4L2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute de Cardiologie de Montreal (Montreal Heart Inst.)</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H1T1C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital du Sacre-Coeur de</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4J1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing AnZhen Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>N China</state>
        <zip>130041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitäts-Herzzentrum Freiburg - Bad Krozingen</name>
      <address>
        <city>Bad Krozingen</city>
        <state>Bad-Wur</state>
        <zip>79189</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elisabeth-Krankenhaus Essen GmbH</name>
      <address>
        <city>Essen</city>
        <state>N. Rhin</state>
        <zip>45138</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität MainzLangenbeckstrasse</name>
      <address>
        <city>Mainz</city>
        <state>Rhinela</state>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Leipzig GmbH04289</name>
      <address>
        <city>Leipzig</city>
        <state>Saxony</state>
        <zip>04289</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Segeberger Kliniken GmbH Am Kurpark 1</name>
      <address>
        <city>Bad Segeberg</city>
        <state>Schlesw</state>
        <zip>23795</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)</name>
      <address>
        <city>Berlin</city>
        <zip>12200</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UKE Hamburg (Universitatsklinik Eppendorf)</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Hong Kong (Queen Mary Hospital)</name>
      <address>
        <city>Hong Kong</city>
        <zip>1928</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Mediterranea</name>
      <address>
        <city>Napoli</city>
        <state>Campani</state>
        <zip>80122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Federico II - Università degli Studi di Napoli</name>
      <address>
        <city>Napoli</city>
        <state>Campani</state>
        <zip>80138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az.Osp. Universitaria di Ferrara</name>
      <address>
        <city>Cona</city>
        <state>Emi-rom</state>
        <zip>44124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU di Parma</name>
      <address>
        <city>Parma</city>
        <state>Emi-rom</state>
        <zip>43126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario A. Gemelli</name>
      <address>
        <city>Roma</city>
        <state>Latium</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Policlinico Umberto I</name>
      <address>
        <city>Rome</city>
        <state>Latium</state>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Cardiologico Monzino</name>
      <address>
        <city>Milano</city>
        <state>Lombard</state>
        <zip>20138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Rozzano</city>
        <state>Lombard</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scheperziekenhuis Boermarkeweg</name>
      <address>
        <city>Emmen</city>
        <state>Drenthe</state>
        <zip>7824</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Centrum Leeuwarden</name>
      <address>
        <city>Leeuwarden</city>
        <state>Friesld</state>
        <zip>8934</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Schweitzer Ziekenhuis Albert Schweitzerplaats</name>
      <address>
        <city>Dordrecht</city>
        <state>Zuid</state>
        <zip>3318</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Santa Cruz</name>
      <address>
        <city>Carnaxide</city>
        <state>Lisbon</state>
        <zip>2799-523</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Maria Hospital</name>
      <address>
        <city>Lisboa</city>
        <state>Lisbon</state>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Heart Centre</name>
      <address>
        <city>Singapore</city>
        <state>Central Singapore</state>
        <zip>169609</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tan Tock Seng Hospital</name>
      <address>
        <city>Singapore</city>
        <state>Singapore Central</state>
        <zip>308433</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCU Virgen de la Victoria Campus Universitario de Teatinos</name>
      <address>
        <city>Málaga</city>
        <state>Andalu</state>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marqués de Valdecilla</name>
      <address>
        <city>Santander</city>
        <state>Cantabr</state>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar Passeig Maritim de la Barceloneta</name>
      <address>
        <city>Barcelona</city>
        <state>Catalon</state>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic I Provincial de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <state>Catalon</state>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valladolid</name>
      <address>
        <city>Valladolid</city>
        <state>Cstleon</state>
        <zip>47005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Alvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <state>Pontev</state>
        <zip>36312</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Doce de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Aarau</name>
      <address>
        <city>Aarau</city>
        <state>Basel</state>
        <zip>5001</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center Inselspital Bern</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Luzerner Kantonsspital</name>
      <address>
        <city>Luzern</city>
        <zip>6004</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Linkou</city>
        <state>NTaiwan</state>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <state>NTaiwan</state>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital (VGH)</name>
      <address>
        <city>Taipei</city>
        <state>Ntaiwan</state>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <state>STailwan</state>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Freeman Hospital</name>
      <address>
        <city>High Heaton</city>
        <state>Newcastle Upon Tyne</state>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Craigavon Area Hospital</name>
      <address>
        <city>Portadown</city>
        <state>Nirelnd</state>
        <zip>BT63 5QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southampton University Hospital</name>
      <address>
        <city>Southampton</city>
        <state>Soeast</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Bournemouth Hospital</name>
      <address>
        <city>Bournemouth</city>
        <state>Sowest</state>
        <zip>BH7 7DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Devon &amp; Exeter Hospital</name>
      <address>
        <city>Exeter</city>
        <state>Sowest</state>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Wales</name>
      <address>
        <city>Cardiff</city>
        <state>Wales</state>
        <zip>CF14 4XW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>China</country>
    <country>Germany</country>
    <country>Hong Kong</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <results_first_submitted>September 15, 2021</results_first_submitted>
  <results_first_submitted_qc>December 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 14, 2021</results_first_posted>
  <last_update_submitted>April 29, 2022</last_update_submitted>
  <last_update_submitted_qc>April 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>High Bleeding Risk (HBR)</keyword>
  <keyword>Dual antiplatelet therapy (DAPT)</keyword>
  <keyword>Drug eluting stent (DES)</keyword>
  <keyword>XIENCE</keyword>
  <keyword>Percutaneous coronary intervention (PCI)</keyword>
  <keyword>Coronary Artery Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Hemorrhagic Stroke</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Thrombocytopenia</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
    <mesh_term>Hematologic Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 4, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03815175/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 4, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03815175/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 1605 subjects were enrolled in XIENCE 28 study. The XIENCE 28 USA study was conducted at 58 sites in the US and Canada between February 25, 2019 and February 7, 2020. While XIENCE 28 Global study was conducted at 52 sites in Europe and Asia between February 9, 2018 and April 22, 2019.</recruitment_details>
      <pre_assignment_details>The data collected from the XIENCE 28 USA Study was pooled with the data from the XIENCE 28 Global Study (NCT # NCT03355742) to compare with the historical control of non-complex HBR subjects treated with standard DAPT duration of up to 12 months from the XIENCE V USA Study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>XIENCE</title>
          <description>XIENCE + 1 month dual antiplatelet therapy (DAPT)&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1605"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1439"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="166"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Subject Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject Withdrawn by Physician/Site</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="86"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Improper/Duplicate SubjectEnrollment</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject Discontinued by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Status Change Reason</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missed Visit</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>XIENCE</title>
          <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1605"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76.15" spread="8.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="538"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1067"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="939"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Did Not Wish to Disclose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Available</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="445"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="327"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="231"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="572"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hong Kong</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Switzerland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Singapore</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Portugal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Percutaneous Coronary Intervention (PCI)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="451"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile</title>
        <description>All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.&#xD;
MI Definition (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Peripheral MI&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
        <time_frame>From 1 to 6 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile</title>
          <description>All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.&#xD;
MI Definition (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Peripheral MI&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1380"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adjusted Overall Rate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1380"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="266"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="407"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="513"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>H0: Death/(MI[1m-DAPT]) - Death/(MI [XIENCE V USA]) ≥ δ HA: Death/MI([1m-DAPT]) - Death/(MI [XIENCE V USA: NCT00676520]) &lt; δ&#xD;
Where δ is the non-inferiority margin. The test will be carried out with a one-sided significance level of 0.025 and a non-inferiority margin (δ) of 2.5%.</non_inferiority_desc>
            <p_value>0.0005</p_value>
            <method>Farrington-Manning method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile</title>
        <description>All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.&#xD;
MI Definition (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Peripheral MI&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
        <time_frame>From 6 to 12 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile</title>
          <description>All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.&#xD;
MI Definition (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Peripheral MI&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1356"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adjusted Overall Rate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1356"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="263"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="401"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="500"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile</title>
        <description>All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.&#xD;
MI Definition (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Peripheral MI&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
        <time_frame>From 1 to 12 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile</title>
          <description>All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.&#xD;
MI Definition (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Peripheral MI&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1381"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adjusted Overall Rate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1381"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="267"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="406"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="513"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Major Bleeding Rate (Bleeding Academic Research Consortium [BARC] Type 2-5), by Propensity Score Quintiles</title>
        <description>Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:&#xD;
Type 2: Any overt, actionable sign of hemorrhage&#xD;
Type 3a: Overt bleeding plus Hb drop of 3 to &lt; 5g/dL;Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision&#xD;
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period&#xD;
Type 5: Fatal bleeding&#xD;
Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious&#xD;
Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation</description>
        <time_frame>From 1 to 6 months</time_frame>
        <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Major Bleeding Rate (Bleeding Academic Research Consortium [BARC] Type 2-5), by Propensity Score Quintiles</title>
          <description>Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:&#xD;
Type 2: Any overt, actionable sign of hemorrhage&#xD;
Type 3a: Overt bleeding plus Hb drop of 3 to &lt; 5g/dL;Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision&#xD;
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period&#xD;
Type 5: Fatal bleeding&#xD;
Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious&#xD;
Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation</description>
          <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1362"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adjusted Overall Rate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1362"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="263"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="404"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="503"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>H0: B (1m-DAPT) - B (XIENCE V USA) ≥ 0 HA: B (1m-DAPT) - B (XIENCE V USA: NCT00676520) &lt; 0&#xD;
B 1m-DAPT and B XIENCE V USA are bleeding rates (BARC type 2-5) between 1-month and 6-month follow-up for the pooled 1-month DAPT arm and XIENCE V USA historical control, respectively.</non_inferiority_desc>
            <p_value>0.1888</p_value>
            <method>Farrington and Manning method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles</title>
        <description>Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:&#xD;
Type 2: Any overt, actionable sign of hemorrhage&#xD;
Type 3a: Overt bleeding plus Hb drop of 3 to &lt; 5g/dL;Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision&#xD;
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period&#xD;
Type 5: Fatal bleeding&#xD;
Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious&#xD;
Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation</description>
        <time_frame>From 6 to 12 months</time_frame>
        <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles</title>
          <description>Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:&#xD;
Type 2: Any overt, actionable sign of hemorrhage&#xD;
Type 3a: Overt bleeding plus Hb drop of 3 to &lt; 5g/dL;Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision&#xD;
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period&#xD;
Type 5: Fatal bleeding&#xD;
Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious&#xD;
Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation</description>
          <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1325"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adjusted Overall Rate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1325"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="257"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="392"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles</title>
        <description>Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:&#xD;
Type 2: Any overt, actionable sign of hemorrhage&#xD;
Type 3a: Overt bleeding plus Hb drop of 3 to &lt; 5g/dL;Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision&#xD;
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period&#xD;
Type 5: Fatal bleeding&#xD;
Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious&#xD;
Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation</description>
        <time_frame>From 1 to 12 months</time_frame>
        <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles</title>
          <description>Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:&#xD;
Type 2: Any overt, actionable sign of hemorrhage&#xD;
Type 3a: Overt bleeding plus Hb drop of 3 to &lt; 5g/dL;Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision&#xD;
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period&#xD;
Type 5: Fatal bleeding&#xD;
Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious&#xD;
Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation</description>
          <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1333"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adjusted Overall Rate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1333"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="259"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="395"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="487"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)</title>
        <description>Definite stent thrombosis:&#xD;
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.&#xD;
Probable stent thrombosis:&#xD;
Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:&#xD;
Any unexplained death within the first 30 days&#xD;
Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause</description>
        <time_frame>From 1 to 6 months</time_frame>
        <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)</title>
          <description>Definite stent thrombosis:&#xD;
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.&#xD;
Probable stent thrombosis:&#xD;
Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:&#xD;
Any unexplained death within the first 30 days&#xD;
Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause</description>
          <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1361"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)</title>
        <description>Definite stent thrombosis:&#xD;
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.&#xD;
Probable stent thrombosis:&#xD;
Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:&#xD;
Any unexplained death within the first 30 days&#xD;
Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause</description>
        <time_frame>From 6 to 12 months</time_frame>
        <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)</title>
          <description>Definite stent thrombosis:&#xD;
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.&#xD;
Probable stent thrombosis:&#xD;
Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:&#xD;
Any unexplained death within the first 30 days&#xD;
Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause</description>
          <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1328"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)</title>
        <description>Definite stent thrombosis:&#xD;
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.&#xD;
Probable stent thrombosis:&#xD;
Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:&#xD;
Any unexplained death within the first 30 days&#xD;
Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause</description>
        <time_frame>From 1 to 12 months</time_frame>
        <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)</title>
          <description>Definite stent thrombosis:&#xD;
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.&#xD;
Probable stent thrombosis:&#xD;
Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:&#xD;
Any unexplained death within the first 30 days&#xD;
Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause</description>
          <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1333"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)</title>
        <description>All Death:&#xD;
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.&#xD;
Cardiac death:&#xD;
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.&#xD;
Vascular death:&#xD;
Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.&#xD;
Non-cardiovascular death:&#xD;
Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.</description>
        <time_frame>From 1 to 6 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)</title>
          <description>All Death:&#xD;
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.&#xD;
Cardiac death:&#xD;
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.&#xD;
Vascular death:&#xD;
Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.&#xD;
Non-cardiovascular death:&#xD;
Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1380"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)</title>
        <description>All Death:&#xD;
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.&#xD;
Cardiac death:&#xD;
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.&#xD;
Vascular death:&#xD;
Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.&#xD;
Non-cardiovascular death:&#xD;
Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.</description>
        <time_frame>From 6 to 12 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)</title>
          <description>All Death:&#xD;
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.&#xD;
Cardiac death:&#xD;
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.&#xD;
Vascular death:&#xD;
Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.&#xD;
Non-cardiovascular death:&#xD;
Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1356"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)</title>
        <description>All Death:&#xD;
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.&#xD;
Cardiac death:&#xD;
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.&#xD;
Vascular death:&#xD;
Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.&#xD;
Non-cardiovascular death:&#xD;
Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.</description>
        <time_frame>From 1 to 12 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)</title>
          <description>All Death:&#xD;
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.&#xD;
Cardiac death:&#xD;
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.&#xD;
Vascular death:&#xD;
Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.&#xD;
Non-cardiovascular death:&#xD;
Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1381"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)</title>
        <description>All Myocardial Infarction (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI:&#xD;
Within 48h after PCI: CK-MB &gt;3 x URL or Troponin &gt; 3 x URL with baseline value &lt; URL&#xD;
Within 72h after CABG: CK-MB &gt;5 x URL or Troponin &gt; 5 x URL with baseline value &lt; URL&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL&#xD;
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.</description>
        <time_frame>From 1 to 6 months</time_frame>
        <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)</title>
          <description>All Myocardial Infarction (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI:&#xD;
Within 48h after PCI: CK-MB &gt;3 x URL or Troponin &gt; 3 x URL with baseline value &lt; URL&#xD;
Within 72h after CABG: CK-MB &gt;5 x URL or Troponin &gt; 5 x URL with baseline value &lt; URL&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL&#xD;
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.</description>
          <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1380"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC)</title>
        <description>All Myocardial Infarction (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI:&#xD;
Within 48h after PCI: CK-MB &gt;3 x URL or Troponin &gt; 3 x URL with baseline value &lt; URL&#xD;
Within 72h after CABG: CK-MB &gt;5 x URL or Troponin &gt; 5 x URL with baseline value &lt; URL&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL&#xD;
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.</description>
        <time_frame>From 6 to 12 months</time_frame>
        <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC)</title>
          <description>All Myocardial Infarction (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI:&#xD;
Within 48h after PCI: CK-MB &gt;3 x URL or Troponin &gt; 3 x URL with baseline value &lt; URL&#xD;
Within 72h after CABG: CK-MB &gt;5 x URL or Troponin &gt; 5 x URL with baseline value &lt; URL&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL&#xD;
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.</description>
          <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1356"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC)</title>
        <description>All Myocardial Infarction (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI:&#xD;
Within 48h after PCI: CK-MB &gt;3 x URL or Troponin &gt; 3 x URL with baseline value &lt; URL&#xD;
Within 72h after CABG: CK-MB &gt;5 x URL or Troponin &gt; 5 x URL with baseline value &lt; URL&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL&#xD;
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.</description>
        <time_frame>From 1 to 12 months</time_frame>
        <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC)</title>
          <description>All Myocardial Infarction (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI:&#xD;
Within 48h after PCI: CK-MB &gt;3 x URL or Troponin &gt; 3 x URL with baseline value &lt; URL&#xD;
Within 72h after CABG: CK-MB &gt;5 x URL or Troponin &gt; 5 x URL with baseline value &lt; URL&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL&#xD;
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.</description>
          <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1381"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Composite of Cardiac Death or MI (Modified ARC)</title>
        <description>Cardiac death:&#xD;
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.&#xD;
MI (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI:&#xD;
Within 48h after PCI: CK-MB &gt;3 x URL or Troponin &gt; 3 x URLwith baseline value &lt; URL&#xD;
Within 72h after CABG: CK-MB &gt;5 x URL or Troponin &gt; 5 x URL with baseline value &lt; URL&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
        <time_frame>From 1 to 6 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Composite of Cardiac Death or MI (Modified ARC)</title>
          <description>Cardiac death:&#xD;
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.&#xD;
MI (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI:&#xD;
Within 48h after PCI: CK-MB &gt;3 x URL or Troponin &gt; 3 x URLwith baseline value &lt; URL&#xD;
Within 72h after CABG: CK-MB &gt;5 x URL or Troponin &gt; 5 x URL with baseline value &lt; URL&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1380"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Composite of Cardiac Death or MI (Modified ARC)</title>
        <description>Cardiac death:&#xD;
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.&#xD;
MI (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI:&#xD;
Within 48h after PCI: CK-MB &gt;3 x URL or Troponin &gt; 3 x URLwith baseline value &lt; URL&#xD;
Within 72h after CABG: CK-MB &gt;5 x URL or Troponin &gt; 5 x URL with baseline value &lt; URL&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
        <time_frame>From 6 to 12 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Composite of Cardiac Death or MI (Modified ARC)</title>
          <description>Cardiac death:&#xD;
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.&#xD;
MI (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI:&#xD;
Within 48h after PCI: CK-MB &gt;3 x URL or Troponin &gt; 3 x URLwith baseline value &lt; URL&#xD;
Within 72h after CABG: CK-MB &gt;5 x URL or Troponin &gt; 5 x URL with baseline value &lt; URL&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1356"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Composite of Cardiac Death or MI (Modified ARC)</title>
        <description>Cardiac death:&#xD;
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.&#xD;
MI (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI:&#xD;
Within 48h after PCI: CK-MB &gt;3 x URL or Troponin &gt; 3 x URLwith baseline value &lt; URL&#xD;
Within 72h after CABG: CK-MB &gt;5 x URL or Troponin &gt; 5 x URL with baseline value &lt; URL&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
        <time_frame>From 1 to 12 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Composite of Cardiac Death or MI (Modified ARC)</title>
          <description>Cardiac death:&#xD;
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.&#xD;
MI (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI:&#xD;
Within 48h after PCI: CK-MB &gt;3 x URL or Troponin &gt; 3 x URLwith baseline value &lt; URL&#xD;
Within 72h after CABG: CK-MB &gt;5 x URL or Troponin &gt; 5 x URL with baseline value &lt; URL&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1381"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Composite of All Death or All MI (Modified ARC)</title>
        <description>All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.&#xD;
MI (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
        <time_frame>From 1 to 6 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Composite of All Death or All MI (Modified ARC)</title>
          <description>All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.&#xD;
MI (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1380"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Composite of All Death or All MI (Modified ARC)</title>
        <description>All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.&#xD;
MI (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
        <time_frame>From 6 to 12 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Composite of All Death or All MI (Modified ARC)</title>
          <description>All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.&#xD;
MI (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1356"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Composite of All Death or All MI (Modified ARC)</title>
        <description>All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.&#xD;
MI (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
        <time_frame>From 1 to 12 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Composite of All Death or All MI (Modified ARC)</title>
          <description>All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.&#xD;
MI (Modified ARC):&#xD;
Patients present any of the following clinical or imaging evidence of ischemia:&#xD;
Clinical symptoms of ischemia;&#xD;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;&#xD;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)&#xD;
AND confirmed with elevated cardiac biomarkers per ARC criteria:&#xD;
Periprocedural MI&#xD;
Spontaneous MI (&gt; 48h following PCI, &gt; 72h following CABG): CK-MB &gt; URL or Troponin &gt; URL with baseline value &lt; URL</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1381"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)</title>
        <description>An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.&#xD;
Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.&#xD;
Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.&#xD;
Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.&#xD;
Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)</description>
        <time_frame>From 1 to 6 months</time_frame>
        <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)</title>
          <description>An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.&#xD;
Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.&#xD;
Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.&#xD;
Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.&#xD;
Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)</description>
          <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1357"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)</title>
        <description>An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.&#xD;
Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.&#xD;
Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.&#xD;
Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.&#xD;
Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)</description>
        <time_frame>From 6 to 12 months</time_frame>
        <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)</title>
          <description>An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.&#xD;
Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.&#xD;
Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.&#xD;
Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.&#xD;
Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)</description>
          <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1320"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)</title>
        <description>An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.&#xD;
Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.&#xD;
Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.&#xD;
Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.&#xD;
Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)</description>
        <time_frame>From 1 to 12 months</time_frame>
        <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)</title>
          <description>An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.&#xD;
Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.&#xD;
Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.&#xD;
Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.&#xD;
Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)</description>
          <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1321"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)</title>
        <description>Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.&#xD;
Clinically Indicated [CI] Revascularization:&#xD;
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:&#xD;
A positive history of recurrent angina pectoris, presumably related to the target vessel;&#xD;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;&#xD;
Abnormal results of any invasive functional diagnostic test&#xD;
A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.</description>
        <time_frame>From 1 to 6 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)</title>
          <description>Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.&#xD;
Clinically Indicated [CI] Revascularization:&#xD;
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:&#xD;
A positive history of recurrent angina pectoris, presumably related to the target vessel;&#xD;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;&#xD;
Abnormal results of any invasive functional diagnostic test&#xD;
A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1380"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With CI-TLR</title>
        <description>Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.&#xD;
Clinically Indicated [CI] Revascularization:&#xD;
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:&#xD;
A positive history of recurrent angina pectoris, presumably related to the target vessel;&#xD;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;&#xD;
Abnormal results of any invasive functional diagnostic test&#xD;
A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.</description>
        <time_frame>From 6 to 12 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With CI-TLR</title>
          <description>Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.&#xD;
Clinically Indicated [CI] Revascularization:&#xD;
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:&#xD;
A positive history of recurrent angina pectoris, presumably related to the target vessel;&#xD;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;&#xD;
Abnormal results of any invasive functional diagnostic test&#xD;
A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1356"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With CI-TLR</title>
        <description>Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.&#xD;
Clinically Indicated [CI] Revascularization:&#xD;
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:&#xD;
A positive history of recurrent angina pectoris, presumably related to the target vessel;&#xD;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;&#xD;
Abnormal results of any invasive functional diagnostic test&#xD;
A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.</description>
        <time_frame>From 1 to 12 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With CI-TLR</title>
          <description>Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.&#xD;
Clinically Indicated [CI] Revascularization:&#xD;
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:&#xD;
A positive history of recurrent angina pectoris, presumably related to the target vessel;&#xD;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;&#xD;
Abnormal results of any invasive functional diagnostic test&#xD;
A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1381"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)</title>
        <description>TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.&#xD;
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:&#xD;
A positive history of recurrent angina pectoris, presumably related to the target vessel;&#xD;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;&#xD;
Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);&#xD;
A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.</description>
        <time_frame>From 1 to 6 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)</title>
          <description>TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.&#xD;
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:&#xD;
A positive history of recurrent angina pectoris, presumably related to the target vessel;&#xD;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;&#xD;
Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);&#xD;
A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1380"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With CI-TVR</title>
        <description>TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.&#xD;
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:&#xD;
A positive history of recurrent angina pectoris, presumably related to the target vessel;&#xD;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;&#xD;
Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);&#xD;
A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.</description>
        <time_frame>From 6 to 12 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With CI-TVR</title>
          <description>TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.&#xD;
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:&#xD;
A positive history of recurrent angina pectoris, presumably related to the target vessel;&#xD;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;&#xD;
Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);&#xD;
A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1356"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With CI-TVR</title>
        <description>TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.&#xD;
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:&#xD;
A positive history of recurrent angina pectoris, presumably related to the target vessel;&#xD;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;&#xD;
Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);&#xD;
A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.</description>
        <time_frame>From 1 to 12 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With CI-TVR</title>
          <description>TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.&#xD;
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:&#xD;
A positive history of recurrent angina pectoris, presumably related to the target vessel;&#xD;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;&#xD;
Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);&#xD;
A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1381"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)</title>
        <description>TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.</description>
        <time_frame>From 1 to 6 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)</title>
          <description>TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1380"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)</title>
        <description>TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.</description>
        <time_frame>From 6 to 12 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)</title>
          <description>TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1356"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)</title>
        <description>TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.</description>
        <time_frame>From 1 to 12 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)</title>
          <description>TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1381"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)</title>
        <description>TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.</description>
        <time_frame>From 1 to 6 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)</title>
          <description>TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1380"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)</title>
        <description>TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.</description>
        <time_frame>From 6 to 12 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)</title>
          <description>TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1356"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)</title>
        <description>TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.</description>
        <time_frame>From 1 to 12 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)</title>
          <description>TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1381"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5</title>
        <description>Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:&#xD;
Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to &lt; 5 g/dL; Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision&#xD;
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period&#xD;
Type 5: Fatal bleeding&#xD;
Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious&#xD;
Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation</description>
        <time_frame>From 1 to 6 months</time_frame>
        <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5</title>
          <description>Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:&#xD;
Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to &lt; 5 g/dL; Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision&#xD;
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period&#xD;
Type 5: Fatal bleeding&#xD;
Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious&#xD;
Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation</description>
          <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1362"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5</title>
        <description>Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:&#xD;
Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to &lt; 5 g/dL; Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision&#xD;
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period&#xD;
Type 5: Fatal bleeding&#xD;
Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious&#xD;
Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation</description>
        <time_frame>From 6 to 12 months</time_frame>
        <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5</title>
          <description>Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:&#xD;
Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to &lt; 5 g/dL; Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision&#xD;
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period&#xD;
Type 5: Fatal bleeding&#xD;
Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious&#xD;
Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation</description>
          <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1325"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5</title>
        <description>Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:&#xD;
Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to &lt; 5 g/dL; Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision&#xD;
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period&#xD;
Type 5: Fatal bleeding&#xD;
Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious&#xD;
Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation</description>
        <time_frame>From 1 to 12 months</time_frame>
        <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
        <group_list>
          <group group_id="O1">
            <title>XIENCE</title>
            <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5</title>
          <description>Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:&#xD;
Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to &lt; 5 g/dL; Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision&#xD;
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period&#xD;
Type 5: Fatal bleeding&#xD;
Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious&#xD;
Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation</description>
          <population>The number of participants analyzed for each time frame and outcome measure will vary based on:&#xD;
Number of subjects who actually completed follow-up for the given time point analyzed&#xD;
The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1333"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>XIENCE</title>
          <description>XIENCE + 1 month DAPT&#xD;
XIENCE: Subjects who received XIENCE family stent systems will be included.&#xD;
DAPT (aspirin and/or P2Y12 receptor inhibitor): &quot;1-month clear&quot; subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for &gt; 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="86" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="615" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Bicytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hypochromic Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Iron Deficiency Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Nephrogenic Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Normochromic Normocytic Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" subjects_affected="91" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Angina Unstable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Aortic Valve Incompetence</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Aortic Valve Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Atrial Flutter</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Atrial Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Atrioventricular Block</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Atrioventricular Block Complete</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Atrioventricular Block Second Degree</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Bifascicular Block</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Acute</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Chronic</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Congestive</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cardiac Tamponade</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cardiogenic Shock</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cardiomegaly</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Congestive Cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Coronary Artery Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Diastolic Dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Dressler's Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Ischaemic Cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Mitral Valve Incompetence</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Myocardial Ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Myopericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pericardial Effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pleuropericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pulseless Electrical Activity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Right Ventricular Failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Sick Sinus Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Sinoatrial Block</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Sinus Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Supraventricular Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Tachyarrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Tricuspid Valve Incompetence</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Ventricular Extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Ventricular Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Vertigo Positional</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperparathyroidism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Retinal Artery Occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Colitis Ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Colonic Polyp</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Duodenal Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Faeces Discoloured</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Gastric Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Gastritis Erosive</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Intestinal Ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Oesophageal Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pancreatitis Acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pancreatitis Necrotising</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Rectal Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Small Intestinal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Varices Oesophageal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Catheter Site Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Chest Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Dysplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>General Physical Health Deterioration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hernia Obstructive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Impaired Healing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Multi-Organ Failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cholecystitis Acute</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hepatic Cirrhosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Jaundice Cholestatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Abscess Limb</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Arthritis Infective</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Bronchopneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cholecystitis Infective</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Corona Virus Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Gallbladder Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Haematoma Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Herpes Zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Infectious Pleural Effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Lobar Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Localised Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Lower Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Lung Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Muscle Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Otitis Externa</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pharyngitis Streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Postoperative Wound Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pyelonephritis Acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Sepsis Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Severe Acute Respiratory Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Soft Tissue Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Vulval Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Wound Infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Clavicle Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Compression Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cranial Nerve Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Femoral Neck Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Femur Fracture</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Foot Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Forearm Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hip Fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Lumbar Vertebral Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Patella Fracture</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pelvic Fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Perirenal Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pubis Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Rib Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Subdural Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Tibia Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Toxicity To Various Agents</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Vascular Graft Complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Vascular Pseudoaneurysm</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Wound Dehiscence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Arteriogram Coronary</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Blood Glucose Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Blood Pressure Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Blood Pressure Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Blood Urine Present</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cardiac Stress Test Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Ejection Fraction Decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Electrocardiogram Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Heart Rate Decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hepatic Enzyme Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Troponin Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Diabetes Mellitus</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Diabetes Mellitus Inadequate Control</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Diabetic Ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Fluid Overload</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Type 2 Diabetes Mellitus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Protrusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Joint Effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Lumbar Spinal Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Osteochondrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pain In Extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Polyarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Spondylitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute Lymphocytic Leukaemia Recurrent</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Biliary Neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Bladder Cancer</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Bladder Transitional Cell Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Colon Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Colon Neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Endometrial Cancer</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Gastric Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Tract Adenoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hepatic Neoplasm Malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Lung Cancer Metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Lung Neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Lung Neoplasm Malignant</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Metastases To Central Nervous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Multiple Myeloma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Myelodysplastic Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Myelofibrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Neoplasm Malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Neuroendocrine Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Non-Small Cell Lung Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Oesophageal Adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pancreatic Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pancreatic Neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pleural Mesothelioma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Prostate Cancer</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Prostate Cancer Metastatic</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Rectal Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Renal Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Small Cell Lung Cancer Metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Squamous Cell Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Squamous Cell Carcinoma Of Skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Transitional Cell Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Urethral Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Carotid Artery Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Carotid Artery Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cauda Equina Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cognitive Disorder</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Complex Regional Pain Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Dementia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Dizziness Postural</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hepatic Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Loss Of Consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Lumbar Radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Metabolic Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Neurodegenerative Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Subarachnoid Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Transient Ischaemic Attack</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Viith Nerve Paralysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional State</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Mental Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic Nephropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Prerenal Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Renal Failure Acute</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Renal Failure Chronic</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign Prostatic Hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Prostatomegaly</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Scrotal Mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Pulmonary Oedema</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Acute Respiratory Distress Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Acute Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Bronchial Hyperreactivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Chronic Obstructive Pulmonary Disease</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Idiopathic Pulmonary Fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pneumonia Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pulmonary Fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pulmonary Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pulmonary Mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Pulmonary Oedema</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Respiratory Arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Diabetic Foot</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Skin Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Subcutaneous Emphysema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Telangiectasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous Fistula Operation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cardiac Pacemaker Insertion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Cataract Operation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Colon Polypectomy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hip Arthroplasty</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hospitalisation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Limb Immobilisation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Mitral Valve Repair</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Osteomyelitis Drainage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Arteriovenous Fistula</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Femoral Arterial Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="84" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hypertensive Crisis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hypertensive Emergency</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Intermittent Claudication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Orthostatic Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Peripheral Arterial Occlusive Disease</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Peripheral Ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Peripheral Vascular Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
              <event>
                <sub_title>Vascular Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="296" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" subjects_affected="123" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="173" subjects_at_risk="1605"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Lijuan Jenn Wang</name_or_title>
      <organization>Abbott</organization>
      <phone>01-408-8453133</phone>
      <email>Lijuan.wang1@abbott.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03815175
org study id: ABT-CIP-10402
nct id: NCT03815175
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized
      trial to evaluate safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in
      subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI)
      with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System
      [EECSS], XIENCE Alpine EECSS and XIENCE Sierra EECSS) of coronary drug-eluting stents.
The XIENCE 28 USA Study will evaluate the safety of 1-month DAPT following XIENCE
      implantation in HBR patients. A minimum of 640 to a maximum of 800 subjects will be
      registered from approximately 50 sites in the United States and Canada. Subject registration
      is capped at 75 per site. Eligibility of P2Y12 receptor inhibitor discontinuation will be
      assessed at 1-month follow-up. Subjects who are free from myocardial infarction (MI), repeat
      coronary revascularization, stroke, or stent thrombosis (ARC definite/probable) within 1
      month (prior to 1-month visit but at least 28 days) after stenting AND have been compliant
      with 1-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for
      > 7 consecutive days are considered as "1-month clear", and will discontinue P2Y12 receptor
      inhibitor as early as 28 days and continued with aspirin monotherapy through 12-month
      follow-up.

      All registered subjects will be followed at 1, 3, 6 and 12 months post index procedure. The
      data collected from the XIENCE 28 USA Study will be pooled with the data from the XIENCE 28
      Global Study (Protocol # ABT-CIP-10235) to compare with the historical control of non-complex
      HBR subjects treated with standard DAPT duration of up to 12 months from the XIENCE V USA
      Study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile
time frame: From 1 to 6 months
description: All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.
MI Definition (Modified ARC):
Patients present any of the following clinical or imaging evidence of ischemia:
Clinical symptoms of ischemia;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality
AND confirmed with elevated cardiac biomarkers per ARC criteria:
Peripheral MI
Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
measure: Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile
time frame: From 6 to 12 months
description: All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.
MI Definition (Modified ARC):
Patients present any of the following clinical or imaging evidence of ischemia:
Clinical symptoms of ischemia;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality
AND confirmed with elevated cardiac biomarkers per ARC criteria:
Peripheral MI
Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
measure: Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile
time frame: From 1 to 12 months
description: All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.
MI Definition (Modified ARC):
Patients present any of the following clinical or imaging evidence of ischemia:
Clinical symptoms of ischemia;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality
AND confirmed with elevated cardiac biomarkers per ARC criteria:
Peripheral MI
Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
measure: Percentage of Participants With Major Bleeding Rate (Bleeding Academic Research Consortium [BARC] Type 2-5), by Propensity Score Quintiles
time frame: From 1 to 6 months
description: Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:
Type 2: Any overt, actionable sign of hemorrhage
Type 3a: Overt bleeding plus Hb drop of 3 to < 5g/dL;Any transfusion with overt bleeding
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents
Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period
Type 5: Fatal bleeding
Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious
Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation
measure: Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles
time frame: From 6 to 12 months
description: Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:
Type 2: Any overt, actionable sign of hemorrhage
Type 3a: Overt bleeding plus Hb drop of 3 to < 5g/dL;Any transfusion with overt bleeding
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents
Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period
Type 5: Fatal bleeding
Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious
Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation
measure: Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles
time frame: From 1 to 12 months
description: Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:
Type 2: Any overt, actionable sign of hemorrhage
Type 3a: Overt bleeding plus Hb drop of 3 to < 5g/dL;Any transfusion with overt bleeding
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents
Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period
Type 5: Fatal bleeding
Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious
Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation
measure: Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
time frame: From 1 to 6 months
description: Definite stent thrombosis:
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.
Probable stent thrombosis:
Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:
Any unexplained death within the first 30 days
Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
measure: Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
time frame: From 6 to 12 months
description: Definite stent thrombosis:
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.
Probable stent thrombosis:
Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:
Any unexplained death within the first 30 days
Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
measure: Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
time frame: From 1 to 12 months
description: Definite stent thrombosis:
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.
Probable stent thrombosis:
Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:
Any unexplained death within the first 30 days
Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
measure: Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)
time frame: From 1 to 6 months
description: All Death:
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.
Cardiac death:
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death:
Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death:
Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
measure: Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)
time frame: From 6 to 12 months
description: All Death:
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.
Cardiac death:
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death:
Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death:
Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
measure: Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)
time frame: From 1 to 12 months
description: All Death:
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.
Cardiac death:
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death:
Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death:
Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
measure: Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
time frame: From 1 to 6 months
description: All Myocardial Infarction (Modified ARC):
Patients present any of the following clinical or imaging evidence of ischemia:
Clinical symptoms of ischemia;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)
AND confirmed with elevated cardiac biomarkers per ARC criteria:
Periprocedural MI:
Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
measure: Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC)
time frame: From 6 to 12 months
description: All Myocardial Infarction (Modified ARC):
Patients present any of the following clinical or imaging evidence of ischemia:
Clinical symptoms of ischemia;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)
AND confirmed with elevated cardiac biomarkers per ARC criteria:
Periprocedural MI:
Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
measure: Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC)
time frame: From 1 to 12 months
description: All Myocardial Infarction (Modified ARC):
Patients present any of the following clinical or imaging evidence of ischemia:
Clinical symptoms of ischemia;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)
AND confirmed with elevated cardiac biomarkers per ARC criteria:
Periprocedural MI:
Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
measure: Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
time frame: From 1 to 6 months
description: Cardiac death:
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
MI (Modified ARC):
Patients present any of the following clinical or imaging evidence of ischemia:
Clinical symptoms of ischemia;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality
AND confirmed with elevated cardiac biomarkers per ARC criteria:
Periprocedural MI:
Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URLwith baseline value < URL
Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
measure: Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
time frame: From 6 to 12 months
description: Cardiac death:
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
MI (Modified ARC):
Patients present any of the following clinical or imaging evidence of ischemia:
Clinical symptoms of ischemia;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality
AND confirmed with elevated cardiac biomarkers per ARC criteria:
Periprocedural MI:
Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URLwith baseline value < URL
Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
measure: Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
time frame: From 1 to 12 months
description: Cardiac death:
Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
MI (Modified ARC):
Patients present any of the following clinical or imaging evidence of ischemia:
Clinical symptoms of ischemia;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality
AND confirmed with elevated cardiac biomarkers per ARC criteria:
Periprocedural MI:
Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URLwith baseline value < URL
Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
measure: Number of Participants With Composite of All Death or All MI (Modified ARC)
time frame: From 1 to 6 months
description: All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.
MI (Modified ARC):
Patients present any of the following clinical or imaging evidence of ischemia:
Clinical symptoms of ischemia;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)
AND confirmed with elevated cardiac biomarkers per ARC criteria:
Periprocedural MI
Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
measure: Number of Participants With Composite of All Death or All MI (Modified ARC)
time frame: From 6 to 12 months
description: All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.
MI (Modified ARC):
Patients present any of the following clinical or imaging evidence of ischemia:
Clinical symptoms of ischemia;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)
AND confirmed with elevated cardiac biomarkers per ARC criteria:
Periprocedural MI
Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
measure: Number of Participants With Composite of All Death or All MI (Modified ARC)
time frame: From 1 to 12 months
description: All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.
MI (Modified ARC):
Patients present any of the following clinical or imaging evidence of ischemia:
Clinical symptoms of ischemia;
ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)
AND confirmed with elevated cardiac biomarkers per ARC criteria:
Periprocedural MI
Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
measure: Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)
time frame: From 1 to 6 months
description: An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.
Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.
Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.
Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.
Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
measure: Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)
time frame: From 6 to 12 months
description: An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.
Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.
Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.
Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.
Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
measure: Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)
time frame: From 1 to 12 months
description: An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.
Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.
Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.
Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.
Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
measure: Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
time frame: From 1 to 6 months
description: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.
Clinically Indicated [CI] Revascularization:
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:
A positive history of recurrent angina pectoris, presumably related to the target vessel;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
Abnormal results of any invasive functional diagnostic test
A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
measure: Number of Participants With CI-TLR
time frame: From 6 to 12 months
description: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.
Clinically Indicated [CI] Revascularization:
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:
A positive history of recurrent angina pectoris, presumably related to the target vessel;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
Abnormal results of any invasive functional diagnostic test
A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
measure: Number of Participants With CI-TLR
time frame: From 1 to 12 months
description: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.
Clinically Indicated [CI] Revascularization:
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:
A positive history of recurrent angina pectoris, presumably related to the target vessel;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
Abnormal results of any invasive functional diagnostic test
A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
measure: Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
time frame: From 1 to 6 months
description: TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:
A positive history of recurrent angina pectoris, presumably related to the target vessel;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);
A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
measure: Number of Participants With CI-TVR
time frame: From 6 to 12 months
description: TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:
A positive history of recurrent angina pectoris, presumably related to the target vessel;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);
A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
measure: Number of Participants With CI-TVR
time frame: From 1 to 12 months
description: TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:
A positive history of recurrent angina pectoris, presumably related to the target vessel;
Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve);
A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
measure: Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
time frame: From 1 to 6 months
description: TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
measure: Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
time frame: From 6 to 12 months
description: TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
measure: Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
time frame: From 1 to 12 months
description: TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
measure: Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)
time frame: From 1 to 6 months
description: TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
measure: Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)
time frame: From 6 to 12 months
description: TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
measure: Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)
time frame: From 1 to 12 months
description: TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
measure: Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5
time frame: From 1 to 6 months
description: Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:
Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to < 5 g/dL; Any transfusion with overt bleeding
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents
Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period
Type 5: Fatal bleeding
Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious
Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation
measure: Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5
time frame: From 6 to 12 months
description: Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:
Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to < 5 g/dL; Any transfusion with overt bleeding
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents
Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period
Type 5: Fatal bleeding
Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious
Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation
measure: Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5
time frame: From 1 to 12 months
description: Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:
Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to < 5 g/dL; Any transfusion with overt bleeding
Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents
Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision
Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period
Type 5: Fatal bleeding
Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious
Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation
arm group label: XIENCE
arm group type: Experimental
description: XIENCE + 1 month DAPT
intervention type: Device
intervention name: XIENCE
description: Subjects who received XIENCE family stent systems will be included.
arm group label: XIENCE
intervention type: Drug
intervention name: DAPT (aspirin and/or P2Y12 receptor inhibitor)
description: "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
arm group label: XIENCE
other name: Dual antiplatelet therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Roxana Mehran, MD
role: Principal Investigator
affiliation: Mount Sinai Medical Center,New York, NY
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country: Austria
country: Belgium
country: Canada
country: China
country: Germany
country: Hong Kong
country: Italy
country: Netherlands
country: Portugal
country: Singapore
country: Spain
country: Switzerland
country: Taiwan
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Hemorrhagic Stroke
mesh term: Renal Insufficiency
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Hemostatic Disorders
mesh term: Thrombocytopenia
mesh term: Blood Coagulation Disorders
mesh term: Hematologic Diseases
mesh term: Aspirin
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