Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve.

Aged Anticoagulants / adverse effects Atrial Fibrillation / complications Bioprosthesis Cardiovascular Diseases / epidemiology Factor Xa Inhibitors / therapeutic use Female Hemorrhage / chemically induced Humans Male Middle Aged Mitral Valve Rivaroxaban / adverse effects Single-Blind Method Stroke / prevention & control Warfarin / adverse effects

Journal

The New England journal of medicine

ISSN: 1533-4406

Titre abrégé: N Engl J Med

Pays: United States

ID NLM: 0255562

Informations de publication

Date de publication:
26 11 2020

Historique:

pubmed: 17 11 2020

medline: 19 12 2020

entrez: 16 11 2020

Statut: ppublish

Résumé

The effects of rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve remain uncertain. In this randomized trial, we compared rivaroxaban (20 mg once daily) with dose-adjusted warfarin (target international normalized ratio, 2.0 to 3.0) in patients with atrial fibrillation and a bioprosthetic mitral valve. The primary outcome was a composite of death, major cardiovascular events (stroke, transient ischemic attack, systemic embolism, valve thrombosis, or hospitalization for heart failure), or major bleeding at 12 months. A total of 1005 patients were enrolled at 49 sites in Brazil. A primary-outcome event occurred at a mean of 347.5 days in the rivaroxaban group and 340.1 days in the warfarin group (difference calculated as restricted mean survival time, 7.4 days; 95% confidence interval [CI], -1.4 to 16.3; P<0.001 for noninferiority). Death from cardiovascular causes or thromboembolic events occurred in 17 patients (3.4%) in the rivaroxaban group and in 26 (5.1%) in the warfarin group (hazard ratio, 0.65; 95% CI, 0.35 to 1.20). The incidence of stroke was 0.6% in the rivaroxaban group and 2.4% in the warfarin group (hazard ratio, 0.25; 95% CI, 0.07 to 0.88). Major bleeding occurred in 7 patients (1.4%) in the rivaroxaban group and in 13 (2.6%) in the warfarin group (hazard ratio, 0.54; 95% CI, 0.21 to 1.35). The frequency of other serious adverse events was similar in the two groups. In patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months. (Funded by PROADI-SUS and Bayer; RIVER ClinicalTrials.gov number, NCT02303795.).

Sections du résumé

BACKGROUND

The effects of rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve remain uncertain.

METHODS

In this randomized trial, we compared rivaroxaban (20 mg once daily) with dose-adjusted warfarin (target international normalized ratio, 2.0 to 3.0) in patients with atrial fibrillation and a bioprosthetic mitral valve. The primary outcome was a composite of death, major cardiovascular events (stroke, transient ischemic attack, systemic embolism, valve thrombosis, or hospitalization for heart failure), or major bleeding at 12 months.

RESULTS

A total of 1005 patients were enrolled at 49 sites in Brazil. A primary-outcome event occurred at a mean of 347.5 days in the rivaroxaban group and 340.1 days in the warfarin group (difference calculated as restricted mean survival time, 7.4 days; 95% confidence interval [CI], -1.4 to 16.3; P<0.001 for noninferiority). Death from cardiovascular causes or thromboembolic events occurred in 17 patients (3.4%) in the rivaroxaban group and in 26 (5.1%) in the warfarin group (hazard ratio, 0.65; 95% CI, 0.35 to 1.20). The incidence of stroke was 0.6% in the rivaroxaban group and 2.4% in the warfarin group (hazard ratio, 0.25; 95% CI, 0.07 to 0.88). Major bleeding occurred in 7 patients (1.4%) in the rivaroxaban group and in 13 (2.6%) in the warfarin group (hazard ratio, 0.54; 95% CI, 0.21 to 1.35). The frequency of other serious adverse events was similar in the two groups.

CONCLUSIONS

In patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months. (Funded by PROADI-SUS and Bayer; RIVER ClinicalTrials.gov number, NCT02303795.).

Identifiants

DOI: 10.1056/NEJMoa2029603 PMID: 33196155

pubmed: 33196155

doi: 10.1056/NEJMoa2029603

doi:

Substances chimiques

Anticoagulants 0

Factor Xa Inhibitors 0

Warfarin 5Q7ZVV76EI

Rivaroxaban 9NDF7JZ4M3

Banques de données

ClinicalTrials.gov

['NCT02303795']

Types de publication

Comparative Study Equivalence Trial Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

2117-2126

Investigateurs

Otávio Berwanger (O)

Hélio Penna Guimarães (HP)

Ricardo Pavanello (R)

Roney O Sampaio (RO)

Pedro Gabriel Melo de Barros E Silva (PG)

Renato D Lopes (RD)

Carlos C Magalhães (CC)

John H Alexander (JH)

Flávio Tarasoutchi (F)

Alexandre B Cavalcanti (AB)

Pedro G M B Silva (PGMB)

Andre Zimerman (A)

Fernando Zampieri (F)

José Amalth (J)

M Julia Machline-Carrion (MJ)

Remo Holanda Furtado (RH)

Roger Oliveira (R)

Thiago Macêdo (T)

Flavia Cristina Soares Kojima (FC)

José C Nicolau (JC)

Marcelo Franken (M)

Athos Damiani (A)

Alexandre Biasi Cavalcanti (A)

Beatriz Gonzales Pacheco da Silva (B)

Bruna Dos Santos Sampaio (B)

Flávia Cristina Soares Kojima (FC)

Eliana Vieira Santucci (E)

Denise de Moraes Paisani (D)

Helio Penna Guimarães (H)

Juliana Rodrigues Yamashita Dos Santos (J)

Lucas Petri Damiani (L)

Nanci Valeis (N)

Renato Hideo Nakagawa Santos (R)

Viviane Bezerra Campos (V)

Joao F M Ferreira (JFM)

Jose F K Saraiva (JFK)

Francisco H Fonseca (FH)

Ibraim M Pinto (IM)

Otavio Berwanger (O)

Adail Paixão Almeida (AP)

Carlos Alberto Mendonça Caprini (CA)

Carlos Roberto de Matos Filho (CR)

Adrian Kormann (A)

Frederico Thomaz Ultramari (FT)

Marcelo Mendes Farinazzo (M)

Anne Marchi (A)

Jádina Spricigo (J)

Milena Kelner (M)

Aguinaldo F Freitas (AF)

Diogo Pereira Santos Sampaio (D)

Israel Guilharde Maynarde (I)

Elis Freitas (E)

Alberto Takeshi Kiyose (A)

Alexandre Cabral Zilli (A)

Luis Carlos Bettiati (LC)

Raul Gaston Sanchez Mas (RG)

Aline Sterque Villacorta (A)

Julia Moscoso (J)

Simone Raimondi (S)

Álvaro Rabelo Júnior (Á)

Natali Dos Reis Santos da Silva (N)

Mayana Almeida (M)

Bruno Ramos Nascimento (B)

Carlos Augusto Formiga Arêas (CA)

Izabela Rodarte Falco (I)

Carisi Anne Polanczyk (CA)

Rafael Luiz Rech (RL)

Ruhan Falcao Peruchi (R)

Gabriela Fehrenbach (G)

Maicon Falavigna (M)

Brenda Santos (B)

Juliana Zeni (J)

Frederico Giacomoni Pesce (FG)

Janaina Albuquerque (J)

Carlos E B de Lima (CEB)

Antônio Moreira de Sousa Neto (A)

Rosielly Melo Tavares (R)

Marina de Deus Moura de Lima (M)

Cézar Eumann Mesas (C)

Manoel Fernandes Canesin (M)

Mayara Santos (M)

Conrado Roberto Hoffmann Filho (CR)

Edilson Alvaro Roma (E)

Carla Beatriz Pimentel Cesar Hoffmann (CB)

Rony Augusto de Oliveira (RA)

Rafael de March Ronsoni (R)

Dalton Bertolim Precoma (D)

Janaina Bernardi Barea (J)

Camila Richter (C)

German Esteban Arcos Gonzalez (GE)

Eliane Sehnem (E)

Cristina Cristina (C)

P Correa (P)

Ana Flávia Mattos (AF)

Alline Sehnem (A)

Diana Patrícia Lamprea Sepulveda (DP)

Pedro Rafael de Oliveira (PR)

Eveline Lustosa Pires Almeida (E)

Tawanna Xavier Marques de Carvalho (TX)

Diogo Oliveira Barreto (D)

Carina Laranja Mattos Barreto (C)

Renata Melo de Vicente da Penha (RM)

Epotamenides Maria Good God (EM)

Estevão Lanna Figueiredo (E)

Bruna Edilena Paulino Azevedo (BE)

Fabio Rocha Farias (F)

Rodrigo Cerci (R)

Sandra Solci Zier (S)

Fábio Serra Silveira (F)

Marcos Serra Silveira (M)

Maelyn Goeking de Oliveira Silveira (M)

Fernando A Atik (FA)

Elson B Lima (EB)

Ruanna de Moura Rodrigues (R)

Rayane Maria Campos Lacourt (RM)

Kaytiussia Raulino de Sena (K)

Etinéia Araujo Gomes Lino (E)

Thais Coutinho da Silva (T)

Ana Amélia (A)

Manoel Lucas (M)

Fernando Augusto Marinho Dos Santos Figueira (FA)

Verônica Soares Monteiro (V)

Danielle Menor (D)

Tais Lins (T)

Frederico Toledo Campo Dall'Orto (F)

Gislayne Ribeiro (G)

Helder José Lima Reis (HJ)

Laila Beatriz (L)

Adriana Lameira (A)

Ágda Leal (Á)

Idelzuita Leandro Liporace (IL)

Nádia Marchiori Galassi (N)

Percy Chaves Taborga (P)

Fernanda Maria Lopes (FM)

Arlets Angélica Moreira (AA)

Jaime Giovany Arnez Maldonado (JG)

Simão Gonçalves Maduro (S)

João David de Souza Neto (JD)

Dafne Lopes Salles (D)

Lorena Campos de Souza (L)

João Manoel Theotonio Dos Santos (JM)

Rafael Kazu Osugue (R)

Silvio Desfini Guerra (S)

João Miguel Malta Dantas (JM)

Talita Uliana (T)

Romário Lopes (R)

Luanna Oliveira (L)

Ellen Peroni (E)

José Armando Mangione (JA)

Bárbara Palacios (B)

Karen Iwagoe (K)

José Francisco Kerr Saraiva (JF)

Carla Cristina Vicente (CC)

Midiã Kaneblai Martins Costa (M)

Josiane de Souza (J)

Edilene Severino (E)

Roberto Leo da Silva (RL)

Jamil Cherem (J)

Vera Lucia Pereira (VL)

Luciana Reis Katz Weiand (L)

Adriano Roberto Dos Santos (AR)

Marcelo Pandolfo (M)

José Dantas Lima (J)

Bruna Dacroce (B)

Gustavo Bento Rodrigues (G)

Dalvoerci Pires (D)

Margaret Assad Cavalcante (M)

Lucas Lima de Moraes (L)

Maria Sanali Moura de Oliveira Paiva (MSMO)

André Francisco de Paula Antonangelo (AF)

Kennya Medeiros (K)

Nayara Thédiga (N)

Marianna Deway Andrade Dracoulakis (M)

Natalia Santos (N)

Paulo Leães (P)

Raquel Osorio Luiz (R)

Paulo S A Kalil (PSA)

Luís E Rohde (LE)

Ricardo D'Oliveira Vieira (R)

Daniel Vicente (D)

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Clotildes Santiago Prates Queirantes (C)

Thamyres Santini Arroyo Cruz (T)

Rodrigo de Lemos Soares Patriota (R)

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Rodrigo Pinto Pedrosa (R)

Tarcisio Raul Lavareda de Souza Filho (TR)

Rogério Carregoza Dantas (R)

Roney Orismar Sampaio (R)

Flavio Tarasoutchi (F)

Milena Ribeiro Paixão (M)

Antônio Fernando Barros de Azevedo Filho (AF)

Marcelo Bettega (M)

Rute Ribeiro (R)

Roque Aras (R)

Fabio Figueiredo Costa (F)

Sérgio Luiz Zimmermann (SL)

Elizabeth Maria Burger Zimmermann (EM)

Tiago Luiz Luz Leiria (TL)

Eduardo Dytz Almeida (E)

Silvia Zottis Poletti (S)

Lais Machado Hoscheidt (L)

Valdir A Moises (VA)

Alberto Takeshi Kyiose (A)

Valquíria Pelisser Campagnucci (V)

Vinícius José da Silva Nina (VJ)

Renata Melo de Assis (R)

Joima Tobias (J)

Commentaires et corrections

Type : CommentIn