Ciou Wei-Siang, Wang Chi-Chuan, Lin Fang-Ju, Chao Tze-Fan, Lin Shin-Yi
Graduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.
Graduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan; Department of Pharmacy, National Taiwan University Hospital, Taipei, Taiwan; School of Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.
Heart Rhythm. 2024 Jun;21(6):715-722. doi: 10.1016/j.hrthm.2024.01.025. Epub 2024 Jan 22.
The optimal dose of direct oral anticoagulants (DOACs) to prevent ischemic stroke (IS) and systemic thromboembolism (STE) in atrial fibrillation (AF) patients with a predisposing bleeding risk remains unclear.
The purpose of this study was to compare the effectiveness and safety of different DOAC dosage regimens in AF patients with high bleeding risk but low thrombosis risk.
This retrospective observational study was conducted with the National Health Insurance claims database in Taiwan to include AF patients aged 20 up to 75 years, under DOAC therapy, with CHADS-VASc score of 1 for males and 2 for females and HAS-BLED score ≥3. Standard-dose regimen was defined as dabigatran 300 mg, rivaroxaban 20 mg, apixaban 10 mg, or edoxaban 60 mg per day. Any other lower-dose regimen were defined as the low-dose regimen. The primary outcomes were IS and major bleeding (MB). The secondary outcomes were STE, gastrointestinal bleeding, intracranial hemorrhage, and cardiovascular death.
A total of 964 patients were included (52.1% standard-dose regimen). Median HAS-BLED score was 3 [interquartile range 3-3]. Compared with standard-dose group, patients in the low-dose group had a significantly increased risk of IS (adjusted hazard ratio [aHR] 5.13; 95% confidence interval 1.37-19.22) and STE (aHR 3.14 [1.05-9.37]) but similar risk of MB (aHR 0.45 [0.12-1.67]). The risks of other hemorrhage and cardiovascular death were similar between the 2 dose groups.
Among patients with a predominant bleeding risk but relatively low thrombosis risk, the low-dose DOAC regimen is not a more appropriate selection than standard-dose regimen.
对于有出血风险倾向的心房颤动（AF）患者，预防缺血性卒中（IS）和全身性血栓栓塞（STE）的直接口服抗凝剂（DOAC）最佳剂量仍不明确。
本研究旨在比较不同DOAC剂量方案在高出血风险但低血栓形成风险的AF患者中的有效性和安全性。
本回顾性观察研究利用台湾国民健康保险理赔数据库，纳入年龄在20至75岁、接受DOAC治疗、男性CHADS-VASc评分为1且女性为2且HAS-BLED评分≥3的AF患者。标准剂量方案定义为每日达比加群300毫克、利伐沙班20毫克、阿哌沙班10毫克或依度沙班60毫克。任何其他较低剂量方案定义为低剂量方案。主要结局为IS和大出血（MB）。次要结局为STE、胃肠道出血、颅内出血和心血管死亡。
共纳入964例患者（52.1%为标准剂量方案）。HAS-BLED评分中位数为3[四分位间距3-3]。与标准剂量组相比，低剂量组患者发生IS（调整后风险比[aHR]5.13；95%置信区间1.37-19.22）和STE（aHR 3.14[1.05-9.37]）的风险显著增加，但MB风险相似（aHR 0.45[0.12-1.67]）。两组间其他出血和心血管死亡风险相似。
在出血风险占主导但血栓形成风险相对较低的患者中，低剂量DOAC方案并非比标准剂量方案更合适的选择。
