6/29/23, 1:37 AM PIONEER AF-PCI (low-dose rivaroxaban) Pathway Feedback Search Clinical Topics Home Studies PIONEER AF PCI (low-dose rivaroxaban) PIONEER AF PCI (low-dose rivaroxaban) Disease Atrial fibrillation Trial question What is the role of low-dose rivaroxaban in patients with AF undergoing PCI? Study design Multi-center Open label RCT Population Characteristics of study participants 26.0% female N = 1415 74.0% male 1415 patients (369 female, 1046 male) Inclusion criteria: patients with nonvalvular AF who had undergone PCI with stenting Key exclusion criteria: history of stroke or TIA; clinically significant gastrointestinal bleeding within 12 months; calculated CrCl < 30 mL/min; increased risk of bleeding Interventions N=709 low-dose rivaroxaban (rivaroxaban 15 mg/day plus P2Y12 inhibitor for 12 months) N=706 standard therapy (standard therapy with a dose-adjusted vitamin K antagonist once daily plus dual antiplatelet therapy for 1, 6, or 12 months) Primary outcome Clinically significant bleeding https://web.pathway.md/studies/receAFVlfs8QcR8Hz 1/2 6/29/23, 1:37 AM PIONEER AF-PCI (low-dose rivaroxaban) Pathway 26.7 % 26.7 20.0 % 16.8 13.3 % Significant decrease 6.7 % NNT = 10 0.0 % Low-dose rivaroxaban Standard therapy Significant decrease in clinically significant bleeding (16.8% vs. 26.7%; HR 0.59, 95% CI 0.47 to 0.76) Secondary outcomes No significant difference in major adverse cardiovascular event (6.5% vs. 6%; HR 1.08, 95% CI 0.69 to 1.68) No significant difference in death from cardiovascular causes (2.4% vs. 1.9%; HR 1.29, 95% CI 0.59 to 2.8) No significant difference in stent thrombosis (0.8% vs. 0.7%; HR 1.2, 95% CI 0.32 to 4.45) Conclusion In patients with nonvalvular AF who had undergone PCI with stenting, low-dose rivaroxaban was superior to standard therapy with respect to clinically significant bleeding. Reference C Michael Gibson, Roxana Mehran, Christoph Bode et al. Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI. N Engl J Med. 2016 Dec 22;375(25):2423-2434. Open reference URL https://web.pathway.md/studies/receAFVlfs8QcR8Hz 2/2