四种直接口服抗凝剂在亚洲非瓣膜性心房颤动患者中的有效性和安全性。
Effectiveness and Safety of Four Direct Oral Anticoagulants in Asian Patients With Nonvalvular Atrial Fibrillation.
机构信息
Cardiovascular Department, Chang Gung Memorial Hospital, Taoyuan, Taiwan; Microscopy Core Laboratory, Chang Gung Memorial Hospital, Taoyuan, Taiwan; School of Traditional Chinese Medicine, College of Medicine, Chang Gung University, Taoyuan, Taiwan; School of Medicine, College of Medicine, Chang Gung University, Taoyuan, Taiwan.
Cardiovascular Department, Chang Gung Memorial Hospital, Taoyuan, Taiwan; School of Medicine, College of Medicine, Chang Gung University, Taoyuan, Taiwan; Graduate Institute of Clinical Medical Sciences, Chang Gung University, Taoyuan, Taiwan.
出版信息
Chest. 2019 Sep;156(3):529-543. doi: 10.1016/j.chest.2019.04.108. Epub 2019 May 16.
BACKGROUND
Whether four direct oral anticoagulants (DOACs) are superior to warfarin in Asian patients with nonvalvular atrial fibrillation (NVAF) remains unclear.
METHODS
This nationwide retrospective cohort study was based on data from Taiwan's National Health Insurance Research Database from June 1, 2012, to December 31, 2017, covering patients with NVAF taking edoxaban (n = 4,577), apixaban (n = 9,952), rivaroxaban (n = 33,022), dabigatran (n = 22,371), and warfarin (n = 19,761). Propensity score weighting was used to balance covariates across study groups. Patients were followed up until occurrence of study outcomes or end date of study.
RESULTS
Edoxaban, apixaban, and rivaroxaban were associated with a lower risk of ischemic stroke/systemic embolism than warfarin. All DOACs had a lower risk of major bleeding than warfarin. Apixaban was associated with a lower risk of major bleeding than rivaroxaban and dabigatran, whereas the risk of major bleeding was comparable between edoxaban and apixaban. The reduced risks of thromboembolism/major bleeding for the four DOACs persisted in high-risk subgroups, including those with chronic kidney disease, elderly patients (age ≥ 75 years), secondary stroke prevention, or CHADS-VASc score (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, previous stroke/transient ischemic attack, vascular disease, age 65-74 years, and female sex) ≥ 4. A total of 2,924 (64%), 6,359 (64%), 31,108 (94%), and 19,821 (89%) patients received low-dose edoxaban (15-30 mg/d), apixaban (2.5 mg bid), rivaroxaban (10-15 mg/d), and dabigatran (110 mg bid), respectively. The effectiveness/safety outcomes with the four low-dose DOACs compared with warfarin were consistent with the main analysis.
CONCLUSIONS
In the largest real-world practice study among Asian patients with NVAF, four DOACs were associated with a comparable or lower risk of thromboembolism, and a lower risk of bleeding than warfarin. There was consistency even among high-risk subgroups and whether standard-or low-dose regimens were compared.
背景
在非瓣膜性心房颤动（NVAF）亚洲患者中，四种直接口服抗凝剂（DOACs）是否优于华法林仍不清楚。
方法
本全国性回顾性队列研究基于 2012 年 6 月 1 日至 2017 年 12 月 31 日台湾全民健康保险研究数据库的数据，涵盖服用依度沙班（n=4577）、阿哌沙班（n=9952）、利伐沙班（n=33022）、达比加群（n=22371）和华法林（n=19761）的 NVAF 患者。采用倾向评分加权法平衡研究组间的协变量。患者随访至研究结局发生或研究结束日期。
结果
与华法林相比，依度沙班、阿哌沙班和利伐沙班发生缺血性卒中和全身性栓塞的风险较低。所有 DOAC 发生大出血的风险均低于华法林。与利伐沙班和达比加群相比，阿哌沙班发生大出血的风险较低，而依度沙班与阿哌沙班发生大出血的风险相似。DOAC 降低血栓栓塞/大出血风险的作用在包括慢性肾脏病、老年患者（年龄≥75 岁）、二级卒中预防或 CHADS-VASc 评分（充血性心力衰竭、高血压、年龄≥75 岁、糖尿病、既往卒中/短暂性脑缺血发作、血管疾病、年龄 65-74 岁和女性）≥4 在内的高危亚组中仍然存在。分别有 2924 例（64%）、6359 例（64%）、31108 例（94%）和 19821 例（89%）患者接受了低剂量依度沙班（15-30mg/d）、阿哌沙班（2.5mg bid）、利伐沙班（10-15mg/d）和达比加群（110mg bid）。与华法林相比，四种低剂量 DOAC 的有效性/安全性结局与主要分析结果一致。
结论
在亚洲 NVAF 患者中进行的最大真实世界实践研究中，与华法林相比，四种 DOAC 发生血栓栓塞的风险相当或更低，出血风险更低。即使在高危亚组中以及比较标准剂量与低剂量方案时，结果也具有一致性。
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