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 - 18/12/20

Doi : 10.1016/j.ahj.2020.10.001

Helio P. Guimarães ^a,^b,^{^⁎} , Pedro G.M. de Barros e Silva ^a, Idelzuita L. Liporace ^c, Roney O. Sampaio ^d, Flávio Tarasoutchi ^d, Milena Paixão ^d, Conrado R. Hoffmann-Filho ^e, Rodrigo Patriota ^f, Tiago L.L. Leiria ^g, Diana Lamprea ^h, Dalton B. Precoma ⁱ, Fernando A. Atik ^j, Fabio S. Silveira ^k, Fabio R. Farias ^l, Diogo O. Barreto ^m, Adail P. Almeida ⁿ, Alexandre C. Zilli ^o, João D. de Souza Neto ^p, Margaret A. Cavalcante ^q, Fernando A.M.S. Figueira ^r, Roque A. Junior ^s, Valdir A. Moisés ^t, Cezar E. Mesas ^u, Roberto V. Ardito ^v, Paulo S.A. Kalil ^w, Maria S.M.O. Paiva ^x, Jaime G.A. Maldonado ^y, Carlos E.B. de Lima ^z, Ricardo D'Oliveira Vieira ^aa, Ligia Laranjeira ^a, Flávia Kojima ^a, Lucas Damiani ^a, Renato H. Nakagawa ^a, Juliana R.Y. dos Santos ^a, Bruna S. Sampaio ^a, Viviane B. Campos ^a, Jose F.K. Saraiva ^ab,^ac, Francisco H. Fonseca ^t,^ac, Ibraim M. Pinto ^ac, Carlos C. Magalhães ^ac, Joao F.M. Ferreira ^d,^ac, Renato D. Lopes ^ad, Ricardo Pavanello ^a,^ac, Alexandre B. Cavalcanti ^a, Otavio Berwanger ^a,^b,^ac
On behalf of the RIVER (RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial -RIVER Trial) Investigators
^a Research Institute – Heart Hospital (HCor), São Paulo, Brazil
^b Hospital Israelita Albert Einstein, São Paulo-SP, Brazil
^c Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
^d Incor – Instituto do Coração do HCFMUSP, São Paulo, Brazil
^e Hospital Regional Hans Dieter Schmidt – Joinvile, Brazil
^f Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho, Brazil
^g Instituto de Cardiologia do Rio Grande do Sul (FUC), Porto Alegre, Brazil
^h Procape, Recife, Brazil
ⁱ Sociedade Hospitalar Angelina Caron, Campina Grande do Sul, Brazil
^j Instituto de Cardiologia do Distrito Federal, Brasília, Brazil
^k Clínica do Coração Sergipe – Aracajú, Brazil
^l Quanta Diagnóstico e Terapia, Curitiba, Brazil
^m Hospital Evangélico de Vila Velha, Vila Velha, Brazil
ⁿ Unidade Médico Cirúrgica – Unimec, Vitória da Conquista, Brazil
^o Hospital de Caridade São Vicente de Paulo, Jundiaí, Brazil
^p Hospital Messejana, Ceará, Brazil
^q Hospital Regional de Presidente Prudente, Presidente Prudente, Brazil
^r IMIP – Instituto de Medicina Integral Professor Fernando Figueira, Recife, Brazil
^s HUPES-Hospital Universitário Prof Edgard Santos, Salvador, Brazil
^t UNIFESP, São Paulo, Brazil
^u Hospital de Universidade Estadual de Londrina, Londrina, Brazil
^v IMC – Instituto de Moléstias Cardiovasculares, São José do Rio Preto, Brazil
^w Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil
^x Eurolatino Natal Center, Natal, Brazil
^y Serviço de Eletrofisiologia e Marca-Passo do Hospital Universitário Francisca Mendes (HUFM)-Manaus, Brazil
^z Cardiolima Piauí, Teresina, Brazil
^aa Hospital e Clínica São Roque, Ipiaú, Brazil
^ab Instituto de Pesquisa Clínica de Campinas, Campinas, Brazil
^ac Sociedade de Cardiologia do Estado de São Paulo (SOCESP), Sao Paulo, Brazil
^ad Duke Clinical Research Institute (DCRI), Durham-NC

^⁎Reprint requests: Helio Penna Guimaraes, MD, PhD, HCor Research Institute, Rua Abilio Soares, 250, 12° andar, São Paulo-SP, CEP 04004-030.HCor Research Institute, Rua Abilio Soares, 250, 12° andarSão Paulo-SPCEP 04004-030

Background

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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Plan

Recommendations for antithrombotic therapy for patients with bioprosthetic valves

Evidence for rivaroxaban in atrial fibrillation

Randomization and allocation concealment

Trial interventions

Co-interventions

Trial procedures and follow-up

Statistical analysis

Sample size

Additional pre-specified analyses

Organizational structure

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Vol 231

P. 128-136 - janvier 2021 Retour au numéro

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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 - 18/12/20

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