巴西艾伯特·爱因斯坦以色列医院Otavio Berwanger团队研究了利伐沙班治疗房颤和生物二尖瓣患者的疗效。2020年11月14日，该研究发表在《新英格兰医学杂志》上。

利伐沙班治疗房颤和生物二尖瓣患者的效果尚不确定。

在这项随机试验中，研究组招募房颤和生物二尖瓣患者，将其随机分组，分别接受利伐沙班与华法林治疗。主要结局是死亡、重大心血管事件（中风、短暂性脑缺血发作、系统性栓塞、瓣膜血栓形成或因心力衰竭住院）、或在12个月时发生大出血的综合结局。

研究组共在巴西的49个研究机构招募了1005名患者。利伐沙班组患者平均347.5天发生一次主要结局，华法林组平均340.1天发生一次。利伐沙班组中有17例患者（3.4％）发生心血管原因死亡或血栓栓塞事件，华法林组中有26例（5.1％），风险比为0.65。利伐沙班组中风发生率为0.6％，华法林组为2.4％，风险比为0.25。利伐沙班组有7例（1.4％）患者发生大出血，显著低于华法林组（13例，2.6％），风险比0.54。两组间其他严重不良事件的发生率相似。

研究结果表明，对于房颤和生物二尖瓣患者，采用利伐沙班治疗在死亡、重大心血管事件或12个月时大出血的主要结局方面不逊于华法林。

附：英文原文

Title: Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve | NEJM

Author: Helio P. Guimares, M.D., Ph.D.,, Renato D. Lopes, M.D., Ph.D.,, Pedro G.M. de Barros e Silva, M.D., Ph.D.,, Idelzuita L. Liporace, M.D.,, Roney O. Sampaio, M.D., Ph.D.,, Flávio Tarasoutchi, M.D., Ph.D.,, Conrado R. Hoffmann-Filho, M.D.,, Rodrigo de Lemos Soares Patriota, M.D.,, Tiago L.L. Leiria, M.D., Ph.D.,, Diana Lamprea, M.D.,, Dalton B. Precoma, M.D., Ph.D.,, Fernando A. Atik, M.D., Ph.D.,, Fabio S. Silveira, M.D.,, Fabio R. Farias, M.D.,, Diogo O. Barreto, M.D.,, Adail P. Almeida, M.D.,, Alexandre C. Zilli, M.D.,, Joo D. de Souza Neto, M.D., Ph.D.,, Margaret A. Cavalcante, M.D.,, Fernando A.M.S. Figueira, M.D.,, Flávia C.S. Kojima, B.Sc.,, Lucas Damiani, M.Sc.,, Renato H.N. Santos, B.S.,, Nanci Valeis, L.L.B.,, Viviane B. Campos, B.Sc.,, Jose F.K. Saraiva, M.D., Ph.D.,, Francisco H. Fonseca, M.D., Ph.D.,, Ibraim M. Pinto, M.D., Ph.D.,, Carlos C. Magalhes, M.D., Ph.D.,, Joao F.M. Ferreira, M.D., Ph.D.,, John H. Alexander, M.D., M.H.S.,, Ricardo Pavanello, M.D., Ph.D.,, Alexandre B. Cavalcanti, M.D., Ph.D.,, and Otavio Berwanger, M.D., Ph.D.

Issue&Volume: 2020-11-14

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.

DOI: 10.1056/NEJMoa2029603

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2029603