Home Health News Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve

Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve

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Abstract

Background

The results of rivaroxaban in sufferers with atrial fibrillation and a bioprosthetic mitral valve stay unsure.

Methods

In this randomized trial, we in contrast rivaroxaban (20 mg as soon as every day) with dose-adjusted warfarin (goal worldwide normalized ratio, 2.0 to 3.0) in sufferers with atrial fibrillation and a bioprosthetic mitral valve. The main consequence was a composite of dying, main cardiovascular occasions (stroke, transient ischemic assault, systemic embolism, valve thrombosis, or hospitalization for coronary heart failure), or main bleeding at 12 months.

Results

A complete of 1005 sufferers have been enrolled at 49 websites in Brazil. A primary-outcome occasion occurred at a imply of 347.5 days in the rivaroxaban group and 340.1 days in the warfarin group (distinction calculated as restricted imply survival time, 7.4 days; 95% confidence interval [CI], −1.4 to 16.3; P<0.001 for noninferiority). Death from cardiovascular causes or thromboembolic occasions occurred in 17 sufferers (3.4%) in the rivaroxaban group and in 26 (5.1%) in the warfarin group (hazard ratio, 0.65; 95% CI, 0.35 to 1.20). The incidence of stroke was 0.6% in the rivaroxaban group and 2.4% in the warfarin group (hazard ratio, 0.25; 95% CI, 0.07 to 0.88). Major bleeding occurred in 7 sufferers (1.4%) in the rivaroxaban group and in 13 (2.6%) in the warfarin group (hazard ratio, 0.54; 95% CI, 0.21 to 1.35). The frequency of different critical antagonistic occasions was related in the 2 teams.

Conclusions

In sufferers with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the imply time till the first consequence of dying, main cardiovascular occasions, or main bleeding at 12 months. (Funded by PROADI-SUS and Bayer; RIVER ClinicalTrials.gov quantity, NCT02303795.)

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