Cha Myung-Jin, Choi Eue-Keun, Han Kyung-Do, Lee So-Ryoung, Lim Woo-Hyun, Oh Seil, Lip Gregory Y H
From the Department of Internal Medicine, Seoul National University Hospital, Republic of Korea (M.-J.C., E.-K.C., S.O.); Department of Biostatistics, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea (K.-D.H.); Department of Internal Medicine, Soonchunhyang University Hospital Seoul, Republic of Korea (S.-R.L.); Division of Cardiology, Department of Internal Medicine, Seoul National University Boramae Medical Center, Republic of Korea (W.-H.L.); Institute of Cardiovascular Sciences, University of Birmingham, United Kingdom (G.Y.H.L.); and Department of Clinical Medicine, Aalborg Thrombosis Research Unit, Aalborg University, Denmark (G.Y.H.L.).
Stroke. 2017 Nov;48(11):3040-3048. doi: 10.1161/STROKEAHA.117.018773. Epub 2017 Oct 3.
There are limited real-world data comparing the effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin in Asians with nonvalvular atrial fibrillation. We aimed to compare the effectiveness and safety between NOACs and warfarin users in the Korean atrial fibrillation population, with particular focus on high-risk patients.
Using the Korean National Health Insurance Service database, we analyzed the risk of ischemic stroke, intracranial hemorrhage (ICH) events, and all-cause death in NOAC users (n=11 611 total, n=5681 taking rivaroxaban, n=3741 taking dabigatran, and n=2189 taking apixaban) compared with propensity score-matched warfarin users (n=23 222) among patients with high-risk atrial fibrillation (CHADS-VASc score ≥2) between 2014 and 2015.
NOAC treatment was associated with similar risk of ischemic stroke and lower risk of ICH and all-cause mortality compared with warfarin. All 3 NOACs were associated with a similar risk of ischemic stroke and a lower risk of ICH compared with warfarin. Dabigatran and apixaban were associated with a lower risk of total mortality and the composite net clinical outcome (ischemic stroke, ICH, and all-cause death) compared with warfarin, whereas this was nonsignificant for rivaroxaban. Among previously oral anticoagulant-naive patients (n=23 262), dabigatran and apixaban were superior to warfarin for ICH prevention, whereas rivaroxaban and warfarin were associated with similar risk of ICH.
In real-world practice among a high-risk Asian atrial fibrillation population, all 3 NOACs demonstrated similar risk of ischemic stroke and lower risk of ICH compared with warfarin. All-cause mortality was significantly lower only with dabigatran and apixaban.
在亚洲非瓣膜性心房颤动患者中，比较非维生素K拮抗剂口服抗凝药（NOACs）与华法林有效性和安全性的真实世界数据有限。我们旨在比较韩国心房颤动人群中使用NOACs和华法林的有效性和安全性，尤其关注高危患者。
利用韩国国民健康保险服务数据库，我们分析了2014年至2015年间高危心房颤动（CHADS-VASc评分≥2）患者中，NOAC使用者（共11611例，其中5681例服用利伐沙班，3741例服用达比加群，2189例服用阿哌沙班）与倾向评分匹配的华法林使用者（23222例）发生缺血性卒中、颅内出血（ICH）事件和全因死亡的风险。
与华法林相比，NOAC治疗与缺血性卒中风险相似，但ICH和全因死亡率风险较低。与华法林相比，所有3种NOACs发生缺血性卒中的风险相似，ICH风险较低。与华法林相比，达比加群和阿哌沙班的总死亡率和综合净临床结局（缺血性卒中、ICH和全因死亡）风险较低，而利伐沙班则无显著差异。在既往未使用过口服抗凝药的患者（23262例）中，达比加群和阿哌沙班在预防ICH方面优于华法林，而利伐沙班和华法林的ICH风险相似。
在亚洲高危心房颤动人群的实际临床实践中，与华法林相比，所有3种NOACs的缺血性卒中风险相似，ICH风险较低。仅达比加群和阿哌沙班的全因死亡率显著较低。
