Division of Cardiology, Department of Internal Medicine, Soon Chun Hyang University Hospital Seoul, Seoul, Republic of Korea.
Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
J Am Coll Cardiol. 2019 Mar 5;73(8):919-931. doi: 10.1016/j.jacc.2018.11.051.
It is unclear whether the overall effectiveness and safety of direct oral anticoagulants (DOACs) are consistent in patients with nonvalvular atrial fibrillation (AF) and extremely low body weight (<50 kg).
This study compared DOACs with warfarin in AF patients with low body weight.
Using data from the Korean National Health Insurance Service database from January 2014 to December 2016, AF patients with body weight ≤60 kg and who were treated with oral anticoagulants (n = 14,013 taking DOACs and n = 7,576 taking warfarin) were included and examined for ischemic stroke, intracranial hemorrhage (ICH), gastrointestinal bleeding, major bleeding, all-cause death, and composite outcome. The propensity score weighting was used to balance the 2 groups.
Baseline characteristics were well balanced between the 2 groups (mean age 73 years, mean CHADS-VASc score 4, and 28% of patients weighed <50 kg). DOACs were associated with lower risks of ischemic stroke (hazard ratio [HR]: 0.591; 95% confidence interval [CI]: 0.510 to 0.686) and major bleeding (HR: 0.705; 95%: CI 0.601 to 0.825), which were caused by a reduction in ICH (HR: 0.554; 95% CI: 0.429 to 0.713) compared with warfarin. DOAC improved the net clinical benefit compared with warfarin (HR for composite outcome: 0.660; 95% CI: 0.606 to 0.717), and this was consistent in patients who weighed <50 kg (HR for composite outcome: 0.665; 95% CI: 0.581 to 0.762).
In this real-world Asian AF population with low body weight, DOACs showed better effectiveness and safety than warfarin. These results were consistent in patients with extremely low body weight. Regular dosages of DOACs showed comparable results as reduced dosages of DOACs in both effectiveness and safety.
直接口服抗凝剂(DOAC)在非瓣膜性心房颤动(AF)和极低体重(<50kg)患者中的整体疗效和安全性尚不清楚。
本研究比较了 DOAC 与 AF 低体重患者的华法林。
使用 2014 年 1 月至 2016 年 12 月韩国国家健康保险服务数据库的数据,纳入体重≤60kg 且接受口服抗凝剂(n=14013 例服用 DOAC,n=7576 例服用华法林)治疗的 AF 患者,并检查缺血性脑卒中、颅内出血(ICH)、胃肠道出血、大出血、全因死亡和复合结局。采用倾向评分加权法平衡两组。
两组患者的基线特征均衡(平均年龄 73 岁,平均 CHADS-VASc 评分 4 分,28%的患者体重<50kg)。DOAC 降低了缺血性脑卒中(风险比[HR]:0.591;95%置信区间[CI]:0.510 至 0.686)和大出血(HR:0.705;95%CI:0.601 至 0.825)的风险,这归因于 ICH 的减少(HR:0.554;95%CI:0.429 至 0.713)与华法林相比。与华法林相比,DOAC 改善了净临床获益(复合结局的 HR:0.660;95%CI:0.606 至 0.717),在体重<50kg 的患者中也是如此(复合结局的 HR:0.665;95%CI:0.581 至 0.762)。
在这个亚洲真实世界的低体重 AF 人群中,DOAC 比华法林显示出更好的疗效和安全性。在极低体重患者中也有同样的结果。DOAC 的常规剂量在疗效和安全性方面与 DOAC 的减少剂量相当。