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Published on: February 28, 2012
Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve
Helio P Guimarães1, Renato D Lopes1, Pedro G M de Barros E Silva1
1From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).
Background:
The effects of rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve remain uncertain.
Methods:
In this randomized trial, we compared rivaroxaban (20 mg once daily) 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 death, major cardiovascular events (stroke, transient ischemic attack, systemic embolism, valve thrombosis, or hospitalization for heart failure), or major bleeding at 12 months.
Results:
A total of 1005 patients were enrolled at 49 sites in Brazil. A primary-outcome event occurred at a mean of 347.5 days in the rivaroxaban group and 340.1 days in the warfarin group (difference calculated as restricted mean 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 events occurred in 17 patients (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 patients (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 other serious adverse events was similar in the two groups.
Conclusions:
In patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months. (Funded by PROADI-SUS and Bayer; RIVER ClinicalTrials.gov number, NCT02303795.).
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