Rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve
N. Engl. j. med
; 383(22): 1-11, Nov. 2020. graf, tab
Artigo
em Inglês
| CONASS, Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1146447
Biblioteca responsável:
BR79.1
Localização: BR79.1
ABSTRACT
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.
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Coleções:
Bases de dados nacionais
/
Brasil
Base de dados:
CONASS
/
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Assunto principal:
Fibrilação Atrial
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Bioprótese
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Doenças Cardiovasculares
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Acidente Vascular Cerebral
/
Valva Mitral
Tipo de estudo:
Ensaio clínico controlado
Idioma:
Inglês
Revista:
N. Engl. j. med
Ano de publicação:
2020
Tipo de documento:
Artigo
Instituição/País de afiliação:
Centro de Pesquisa Clinica do Coração/BR
/
Duke Clinical Research Institute/US
/
HCor Research Institute/BR
/
Hospital Evangelico de Vila Velha/BR
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Hospital Israelita Albert Einstein/BR
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Hospital Metropolitano Sul Dom Helder Câmara/BR
/
Hospital Regional Hans Dieter Schmidt/BR
/
Hospital Regional de Presidente Prudente/BR
/
Hospital de Caridade São Vicente de Paulo/BR
/
Hospital de Messejana Dr. Carlos Alberto Studart Gomes/BR