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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.

Publication ,  Journal Article
Guimarães, HP; de Barros E Silva, PGM; Liporace, IL; Sampaio, RO; Tarasoutchi, F; Paixão, M; Hoffmann-Filho, CR; Patriota, R; Leiria, TLL ...
Published in: Am Heart J
January 2021

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.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

January 2021

Volume

231

Start / End Page

128 / 136

Location

United States

Related Subject Headings

  • Warfarin
  • Treatment Outcome
  • Thrombosis
  • Surgical Procedures, Operative
  • Stroke
  • Sample Size
  • Rivaroxaban
  • Randomized Controlled Trials as Topic
  • Multicenter Studies as Topic
  • Mitral Valve
 

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Guimarães, H. P., de Barros E Silva, P. G. M., Liporace, I. L., Sampaio, R. O., Tarasoutchi, F., Paixão, M., … RIVER (RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial -RIVER Trial) Investigators, . (2021). 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. Am Heart J, 231, 128–136. https://doi.org/10.1016/j.ahj.2020.10.001
Guimarães, Helio P., Pedro G. M. de Barros E Silva, Idelzuita L. Liporace, Roney O. Sampaio, Flávio Tarasoutchi, Milena Paixão, Conrado R. Hoffmann-Filho, et al. “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.Am Heart J 231 (January 2021): 128–36. https://doi.org/10.1016/j.ahj.2020.10.001.
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. 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. Am Heart J. 2021 Jan;231:128–136.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

January 2021

Volume

231

Start / End Page

128 / 136

Location

United States

Related Subject Headings

  • Warfarin
  • Treatment Outcome
  • Thrombosis
  • Surgical Procedures, Operative
  • Stroke
  • Sample Size
  • Rivaroxaban
  • Randomized Controlled Trials as Topic
  • Multicenter Studies as Topic
  • Mitral Valve