• Helio P Guimarães, Pedro G M de Barros E Silva, Idelzuita L Liporace, Roney O Sampaio, Flávio Tarasoutchi, Milena Paixão, Conrado R Hoffmann-Filho, Rodrigo Patriota, Leiria Tiago L L TLL Instituto de Cardiologia do Rio Grande do Sul (FUC), Porto Alegre, Brazil., Diana Lamprea, Dalton B Precoma, Fernando A Atik, Fabio S Silveira, Fabio R Farias, Diogo O Barreto, Adail P Almeida, Alexandre C Zilli, João D de Souza Neto, Margaret A Cavalcante, Fernando A M S Figueira, Roque A Junior, Valdir A Moisés, Cezar E Mesas, Roberto V Ardito, Paulo S A Kalil, Maria S M O Paiva, Jaime G A Maldonado, Carlos E B de Lima, Ricardo D'Oliveira Vieira, Ligia Laranjeira, Flávia Kojima, Lucas Damiani, Renato H Nakagawa, Juliana R Y Dos Santos, Bruna S Sampaio, Viviane B Campos, Jose F K Saraiva, Francisco H Fonseca, Ibraim M Pinto, Carlos C Magalhães, Joao F M Ferreira, Renato D Lopes, Ricardo Pavanello, Alexandre B Cavalcanti, Otavio Berwanger, and RIVER (RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial -RIVER Trial) Investigators.
• Research Institute - Heart Hospital (HCor), São Paulo, Brazil; Hospital Israelita Albert Einstein, São Paulo-SP, Brazil. Electronic address: heliopg@yahoo.com.br.
• Am. Heart J. 2021 Jan 1; 231: 128-136.

The efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valves and atrial fibrillation or flutter remain uncertain. DESIGN: 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. SummaryRIVER 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.Copyright © 2020 Elsevier Inc. All rights reserved.

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