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.

Journal Article (Journal Article;Multicenter Study)

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.

Full Text

Duke Authors

Cited Authors

  • 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; Berwanger, O; RIVER (RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial -RIVER Trial) Investigators,

Published Date

  • January 2021

Published In

Volume / Issue

  • 231 /

Start / End Page

  • 128 - 136

PubMed ID

  • 33045224

Pubmed Central ID

  • 33045224

Electronic International Standard Serial Number (EISSN)

  • 1097-6744

Digital Object Identifier (DOI)

  • 10.1016/j.ahj.2020.10.001

Language

  • eng

Conference Location

  • United States