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A randomized clinical trial to evaluate the efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valve and atrial fibrillation or flutter: Rationale and design of the RIVER trial

2020; Elsevier BV; Volume: 231; Linguagem: Inglês

10.1016/j.ahj.2020.10.001

1097-6744

Hélio Penna Guimarães, Pedro Gabriel Melo de Barros e Silva, Idelzuíta Leandro Liporace, Roney Orismar Sampaio, Flávio Tarasoutchi, Milena Ribeiro Paixão, Conrado R. Hoffmann-Filho, Rodrigo de Lemos Soares Patriota, Tiago Luiz Luz Leiria, Diana Lamprea, Dalton Bertolim Précoma, Fernando Antibas Atik, Fábio Serra Silveira, Fabio R. Farias, Diogo O. Barreto, Adail Paixão Almeida, Alexandre Cabral Zilli, João David de Souza Neto, Margaret Assad Cavalcante, Fernando A.M.S. Figueira, Ana Beatriz Alves de Oliveira Roque, Valdir Ambrósio Moisés, Cézar Mesas, Roberto Vito Ardito, Paulo Kalil, Maria Sanali Moura Oliveira Paiva, Jaime Giovany Arnez Maldonado, Carlos Eduardo Batista de Lima, Ricardo D’Oliveira Vieira, Lígia Nasi Laranjeira, Flávia Cristina Soares Kojima, Lucas Petri Damiani, Renato Nakagawa, Juliana R.Y. dos Santos, Bruna Sampaio, Viviane Bezerra Campos, José Francisco Kerr Saraiva, Francisco Antônio Helfenstein Fonseca, Ibraim Pinto, Carlos Costa Magalhães, João Fernando Monteiro Ferreira, Renato D. Lópes, Ricardo Pavanello, Alexandre Biasi Cavalcanti, Otávio Berwanger,

Infective Endocarditis Diagnosis and Management

The efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valves and atrial fibrillation or flutter remain uncertain. RIVER was an academic-led, multicenter, open-label, randomized, non-inferiority trial with blinded outcome adjudication that enrolled 1005 patients from 49 sites in Brazil. Patients with a bioprosthetic mitral valve and atrial fibrillation or flutter were randomly assigned (1:1) to rivaroxaban 20 mg once daily (15 mg in those with creatinine clearance <50 mL/min) or dose-adjusted warfarin (target international normalized ratio 2.0-30.); the follow-up period was 12 months. The primary outcome was a composite of all-cause mortality, stroke, transient ischemic attack, major bleeding, valve thrombosis, systemic embolism, or hospitalization for heart failure. Secondary outcomes included individual components of the primary composite outcome, bleeding events, and venous thromboembolism. RIVER represents the largest trial specifically designed to assess the efficacy and safety of a direct oral anticoagulant in patients with bioprosthetic mitral valves and atrial fibrillation or flutter. The results of this trial can inform clinical practice and international guidelines.