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Optimal anticoagulation strategies remain unclear for patients with atrial fibrillation and bioprosthetic valves. The RIVER trial (NCT02303795) assessed the efficacy and safety of standard-dose rivaroxaban compared with dose-adjusted warfarin (to maintain an international normalized ratio [INR] of 2 to 3) in this population.
In this industry-funded trial, 1005 patients underwent randomization across 49 sites in Brazil. The primary outcome was a composite of death, major cardiovascular events (stroke, transient ischemic attacks, systemic embolism, valve thrombosis, or hospitalization for heart failure), or major bleeding at 12 months. The mean CHA2DS2-VASc score was 2.6, and the interval between mitral valve surgery and randomization was less…