1. 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.
- Author
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Guimarães HP, de Barros E Silva PGM, Liporace IL, Sampaio RO, Tarasoutchi F, Paixão M, Hoffmann-Filho CR, Patriota R, Leiria TLL, Lamprea D, Precoma DB, Atik FA, Silveira FS, Farias FR, Barreto DO, Almeida AP, Zilli AC, de Souza Neto JD, Cavalcante MA, Figueira FAMS, Junior RA, Moisés VA, Mesas CE, Ardito RV, Kalil PSA, Paiva MSMO, Maldonado JGA, de Lima CEB, D'Oliveira Vieira R, Laranjeira L, Kojima F, Damiani L, Nakagawa RH, Dos Santos JRY, Sampaio BS, Campos VB, Saraiva JFK, Fonseca FH, Pinto IM, Magalhães CC, Ferreira JFM, Lopes RD, Pavanello R, Cavalcanti AB, and Berwanger O
- Subjects
- Humans, Administration, Oral, Aspirin administration & dosage, Brazil, Cause of Death, Creatinine metabolism, Embolism, Hemorrhage chemically induced, Hospitalization, Ischemic Attack, Transient, Sample Size, Stroke, Surgical Procedures, Operative, Treatment Outcome, Warfarin administration & dosage, Warfarin adverse effects, Warfarin therapeutic use, Equivalence Trials as Topic, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Atrial Fibrillation complications, Atrial Flutter complications, Bioprosthesis adverse effects, Factor Xa Inhibitors administration & dosage, Factor Xa Inhibitors adverse effects, Factor Xa Inhibitors therapeutic use, Heart Valve Prosthesis adverse effects, Mitral Valve, Rivaroxaban administration & dosage, Rivaroxaban adverse effects, Rivaroxaban therapeutic use, Thrombosis etiology, Thrombosis prevention & control
- Abstract
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. SUMMARY: 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., (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Published
- 2021
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