Division of Cardiology, Department of Internal Medicine, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, South Korea.
Division of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
J Am Coll Cardiol. 2019 Mar 19;73(10):1123-1131. doi: 10.1016/j.jacc.2018.12.047.
Patients with mitral stenosis and atrial fibrillation (AF) require anticoagulation for stroke prevention. Thus far, all studies on direct oral anticoagulants (DOACs) have excluded patients with moderate to severe mitral stenosis.
The aim of this study was to validate the efficacy of DOACs in patients with mitral stenosis.
The study population was enrolled from the Health Insurance Review and Assessment Service (HIRA) database in the Republic of Korea, and it included patients who were diagnosed with mitral stenosis and AF and either were prescribed DOACs for off-label use or received conventional treatment with warfarin. The primary efficacy endpoint was ischemic strokes or systemic embolisms, and the safety outcome was intracranial hemorrhage.
A total of 2,230 patients (mean age 69.7 ± 10.5 years; 682 [30.6%] males) were included in the present study. Thromboembolic events occurred at a rate of 2.22%/year in the DOAC group, and 4.19%/year in the warfarin group (adjusted hazard ratio for DOAC: 0.28; 95% confidence interval: 0.18 to 0.45). Intracranial hemorrhage occurred in 0.49% of the DOAC group and 0.93% of the warfarin group (adjusted hazard ratio for DOAC: 0.53; 95% confidence interval: 0.22 to 1.26).
In patients with AF accompanied with mitral stenosis, DOAC use is promising and hypothesis generating in preventing thromboembolism. Our results need to be replicated in a randomized trial.
患有二尖瓣狭窄和心房颤动（AF）的患者需要抗凝治疗以预防中风。迄今为止，所有关于直接口服抗凝剂（DOAC）的研究都排除了中重度二尖瓣狭窄的患者。
本研究旨在验证 DOAC 在二尖瓣狭窄患者中的疗效。
研究人群来自韩国健康保险审查和评估服务（HIRA）数据库，包括被诊断为二尖瓣狭窄和 AF 的患者，他们被处方 DOAC 进行标签外使用或接受华法林的常规治疗。主要疗效终点是缺血性中风或全身性栓塞，安全性结局是颅内出血。
本研究共纳入 2230 名患者（平均年龄 69.7±10.5 岁；682 名[30.6%]男性）。DOAC 组血栓栓塞事件的发生率为 2.22%/年，华法林组为 4.19%/年（DOAC 的调整后危险比：0.28；95%置信区间：0.18 至 0.45）。DOAC 组颅内出血的发生率为 0.49%，华法林组为 0.93%（DOAC 的调整后危险比：0.53；95%置信区间：0.22 至 1.26）。
在伴有二尖瓣狭窄的 AF 患者中，DOAC 预防血栓栓塞具有应用前景和产生假说的潜力。我们的结果需要在随机试验中得到复制。
