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.).
RCT Entities:
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.).
Authors: Dae Hyun Kim; Curtis Tatsuoka; Zhengyi Chen; Jackson T Wright; Michelle C Odden; Srinivasan Beddhu; Brandon K Bellows; Adam Bress; Thaddeus Carson; William C Cushman; Karen C Johnson; Donald E Morisky; Henry Punzi; Leonardo Tamariz; Song Yang; Lee-Jen Wei Journal: J Gen Intern Med Date: 2022-08-09 Impact factor: 6.473
Authors: Renato D Lopes; Pedro Gabriel Melo de Barros E Silva; Remo H M Furtado; Ariane Vieira Scarlatelli Macedo; Bruna Bronhara; Lucas Petri Damiani; Lilian Mazza Barbosa; Júlia de Aveiro Morata; Eduardo Ramacciotti; Priscilla de Aquino Martins; Aryadne Lyrio de Oliveira; Vinicius Santana Nunes; Luiz Eduardo Fonteles Ritt; Ana Thereza Rocha; Lucas Tramujas; Sueli V Santos; Dario Rafael Abregu Diaz; Lorena Souza Viana; Lívia Maria Garcia Melro; Mariana Silveira de Alcântara Chaud; Estêvão Lanna Figueiredo; Fernando Carvalho Neuenschwander; Marianna Deway Andrade Dracoulakis; Rodolfo Godinho Souza Dourado Lima; Vicente Cés de Souza Dantas; Anne Cristine Silva Fernandes; Otávio Celso Eluf Gebara; Mauro Esteves Hernandes; Diego Aparecido Rios Queiroz; Viviane C Veiga; Manoel Fernandes Canesin; Leonardo Meira de Faria; Gilson Soares Feitosa-Filho; Marcelo Basso Gazzana; Idelzuíta Leandro Liporace; Aline de Oliveira Twardowsky; Lilia Nigro Maia; Flávia Ribeiro Machado; Alexandre de Matos Soeiro; Germano Emílio Conceição-Souza; Luciana Armaganijan; Patrícia O Guimarães; Regis G Rosa; Luciano C P Azevedo; John H Alexander; Alvaro Avezum; Alexandre B Cavalcanti; Otavio Berwanger Journal: Lancet Date: 2021-06-04 Impact factor: 79.321