在2020美國心臟學會年會第二天，《新英格蘭醫學雜誌》（NEJM）與大會同步發表一項來自巴西的多中心、非劣效性、隨機對照臨床試驗結果。該論文提示，在使用生物瓣的心房顫動患者中，在至發生主要結局（12個月時的死亡、主要心血管事件或大出血）平均時間方面，利伐沙班不劣於華法林。
我們在此發布該文摘要的中文翻譯。
Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral ValveGuimarães HP, Lopes RD, de Barros e Silva PGM, et al.DOI: 10.1056/NEJMoa2029603
背景
利伐沙班對於二尖瓣使用生物瓣的心房顫動患者的效果尚不明確。
BACKGROUND
The effects of rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve remain uncertain.
方法
在這項隨機試驗中，我們比較了利伐沙班（每日20 mg）和經過劑量調整的華法林（國際標準化比目標值，2.0~3.0）對於二尖瓣使用生物瓣的心房顫動患者的效果。主要結局是由12個月時的死亡、主要心血管事件（卒中、短暫性腦缺血發作、全身性栓塞、瓣膜血栓形成或心力衰竭住院）或大出血構成的複合結局。
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.
結果
共計1005例患者在巴西49個研究中心被納入本研究。利伐沙班組平均在347.5天，華法林組平均在340.1天發生了主要結局事件（計算出的限制平均生存時間[restricted meansurvival time]的差異，7.4天；95%置信區間[CI]，-1.4~16.3；非劣效性的P<0.001）。利伐沙班組17例患者（3.4%）和華法林組26例患者（5.1%）因心血管原因死亡或發生血栓栓塞事件（風險比，0.65；95% CI，0.35~1.20）。利伐沙班組和華法林組的卒中發生率分別為0.6%和2.4%（風險比，0.25；95% CI，0.07~0.88）。利伐沙班組7例患者（1.4%）和華法林組13例患者（2.6%）發生了大出血（風險比，0.54；95% CI，0.21~1.35）。兩組中其他嚴重不良事件的發生率相似。
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.
結論
在二尖瓣使用生物瓣的心房顫動患者中，在至發生主要結局（12個月時的死亡、主要心血管事件或大出血）的平均時間方面，利伐沙班不劣於華法林。（由PROADI-SUS和拜耳資助；RIVER在ClinicalTrials.gov註冊號為NCT02303795。）
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.)
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