6/29/23, 1:12 AM RIVER Pathway Feedback Search Clinical Topics Home Studies RIVER RIVER Disease Disease Atrial fibrillation Mitral regurgitation Trial question Is rivaroxaban noninferior to warfarin in patients with AF and a bioprosthetic mitral valve? Study design Multi-center Open label RCT Population Characteristics of study participants 60.0% female N = 1005 40.0% male 1005 patients (607 female, 398 male) Inclusion criteria: patients with AF and a bioprosthetic mitral valve Key exclusion criteria: contraindication to either rivaroxaban or warfarin; high bleeding risk; transient AF caused by surgery; placement of mechanical valves Interventions N=500 rivaroxaban (oral dose of 20 mg daily) N=505 warfarin (dose adjustment to maintain a target INR of 2.0 to 3.0) Primary outcome Time until death, major cardiovascular events, or major bleeding at 12 months 347.5 347 5 days 340 1 https://web.pathway.md/studies/rec6jah9EcIrGNRk9 1/2 6/29/23, 1:12 AM 347.5 days RIVER Pathway 3 5 340.1 260.6 days 173.8 days Difference not exceeding nonferiority margin 86.9 days 0.0 days Rivaroxaban Warfarin Difference not exceeding nonferiority margin in time until death, major cardiovascular events, or major bleeding at 12 months (347.5 days vs. 340.1 days; AD 7.4 days, 95% CI -1.4 to 16.3) Secondary outcomes No significant difference in death from cardiovascular causes or thromboembolic events (3.4% vs. 5.1%; HR 0.65, 95% CI 0.35 to 1.2) Borderline significant decrease in stroke (0.6% vs. 2.4%; HR 0.25, 95% CI 0.07 to 0.88) No significant difference in valve thrombosis (1% vs. 0.6%; HR 1.68, 95% CI 0.4 to 7.01) Safety outcomes No significant differences in major bleeding, nonmajor bleeding, other serious adverse events. Conclusion In patients with AF and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to time until death, major cardiovascular events, or major bleeding at 12 months. Reference Helio P Guimar es, Renato D Lopes, Pedro G M de Barros E Silva et al. Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve. N Engl J Med. 2020 Nov 26;383(22):2117- 2126. Open reference URL https://web.pathway.md/studies/rec6jah9EcIrGNRk9 2/2