6/29/23, 1:37 AM PIONEER AF-PCI (very-low-dose rivaroxaban) Pathway Feedback Search Clinical Topics Home Studies PIONEER AF PCI (very-low-dose rivaroxaban) PIONEER AF PCI (very-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 (362 female, 1053 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 very-low-dose rivaroxaban (rivaroxaban 2.5 mg BID plus dual antiplatelet therapy for 1, 6, or 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 https://web.pathway.md/studies/recB5ym1RfwexzGAE 1/2 6/29/23, 1:37 AM PIONEER AF-PCI (very-low-dose rivaroxaban) Pathway Clinically significant bleeding 26.7 % 26.7 20.0 % 18 13.3 % Significant decrease 6.7 % NNT = 11 0.0 % Very-low-dose rivaroxaban Standard therapy Significant decrease in clinically significant bleeding (18% vs. 26.7%; HR 0.63, 95% CI 0.5 to 0.8) Secondary outcomes No significant difference in major adverse cardiovascular event (5.6% vs. 6%; HR 0.93, 95% CI 0.59 to 1.48) No significant difference in death from cardiovascular causes (2.2% vs. 1.9%; HR 1.19, 95% CI 0.54 to 2.62) No significant difference in stent thrombosis (0.9% vs. 0.7%; HR 1.44, 95% CI 0.4 to 5.09) Conclusion In patients with nonvalvular AF who had undergone PCI with stenting, very-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/recB5ym1RfwexzGAE 2/2