6/29/23, 1:34 AM PARTNER 2 Pathway Feedback Search Clinical Topics Home Studies PARTNER 2 PARTNER 2 Disease Aortic stenosis Trial question Is TAVR noninferior to SAVR in intermediate-risk patients with severe aortic stenosis? Study design Multi-center Open label RCT Population Characteristics of study participants 45.0% female N = 2032 55.0% male 2032 patients (924 female, 1108 male) Inclusion criteria: intermediate risk patients with severe aortic stenosis Key exclusion criteria: heart team assessment of inoperability, evidence of acute myocardial infarction 1 month, congenital unicuspid or bicuspid aortic valve, mixed aortic valve disease, preexisting mechanical or bioprosthetic valve, complex coronary artery disease, hypertrophic cardiomyopathy with or without obstruction, leukopenia, acute anemia, severe ventricular dysfunction Interventions N=1011 TAVR (transfemoral or transthoracic placement of SAPIEN XT valve system) N=1021 surgery (surgical aortic-valve replacement) https://web.pathway.md/studies/rec8kM8aIqu3xXcoU 1/2 6/29/23, 1:34 AM PARTNER 2 Pathway Primary outcome Death from all causes or disabling stroke at 2 years 21.1 % 21.1 19.3 15.8 % 10.6 % Difference not exceeding nonferiority margin 5.3 % 0.0 % Transcatheter aortic valve replacement Surgery Difference not exceeding nonferiority margin in death from all causes or disabling stroke at 2 years (19.3% vs. 21.1%; HR 0.89, 95% CI 0.73 to 1.09) Secondary outcomes No significant difference in death from any cause at 2 years (16.7% vs. 18%; RR 0.93, 95% CI -1.44 to 3.3) No significant difference in disabling stroke at 2 years (6.2% vs. 6.4%; RR 0.97, 95% CI -7.32 to 9.26) No significant difference in rehospitalization at 2 years (19.6% vs. 17.3%; RR 1.13, 95% CI -0.67 to 2.93) Safety outcomes Significant differences in major vascular complications (7.9% vs. 5.0%), life-threatening bleeding (10.4% vs. 43.4%), AKI (1.3% vs. 3.1%), and new-onset AF (9.1% vs. 26.4%) at 30 days. Conclusion In intermediate risk patients with severe aortic stenosis, TAVR was noninferior to surgery with respect to death from all causes or disabling stroke at 2 years. Reference Leon MB, Smith CR, Mack MJ et al. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. Open reference URL https://web.pathway.md/studies/rec8kM8aIqu3xXcoU 2/2