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Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve


The background

The effect of rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve remains uncertain.


In this randomized trial, we compared rivaroxaban (20 mg once) with dose-adjusted warfarin (target international normalized ratio, 2.0 to 3.0) in patients with atrial fibrillation and a bioprosthetic mitral valve. The primary outcome was a composite of deaths at 12 months, major cardiac events (stroke, transient ischemic attacks, systemic embolism, valve thrombosis, or hospitalization for heart failure).


A total of 1005 patients were admitted to 49 sites in Brazil. One primary-outcome event occurred in the 347.5-day rivaroxane group and 340.1 days in the warfarin group (calculated as the differential limited median survival time, 7.4 days; 95% confidence interval). [CI],, 1.4 to 16.3; P

The conclusion

In patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was without infusion for warfarin in relation to mean time until death, major cardiac events, or primary outcome of major bleeding for 12 months. (Funded by PROADI-SUS and Bayer; RIVER number) NCT02303795.)

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