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依度沙班与阿哌沙班治疗老年非瓣膜性心房颤动患者的有效性和安全性:一项基于真实世界人群的队列研究。

Effectiveness and Safety of Edoxaban Compared With Apixaban in Elderly Patients With Nonvalvular Atrial Fibrillation: A Real-World Population-Based Cohort Study.

作者信息

Chiv Richard, Beradid Sarah, Suissa Samy, Renoux Christel

机构信息

Centre for Clinical Epidemiology, Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Canada (R.C., S.B., S.S., C.R.).

Department of Epidemiology, Biostatistics, and Occupational Health (R.C., S.S., C.R.), McGill University, Montreal, Canada.

出版信息

Stroke. 2024 May;55(5):1161-1170. doi: 10.1161/STROKEAHA.123.045098. Epub 2024 Mar 21.

Abstract

BACKGROUND

The very elderly (≥80 years) are at high risk of nonvalvular atrial fibrillation and thromboembolism. Given its recent approval, the comparative effectiveness and safety of edoxaban in this population, relative to the commonly used apixaban, remain unknown.

METHODS

Using the United Kingdom Clinical Practice Research Datalink, we identified a cohort of patients aged ≥80 with incident nonvalvular atrial fibrillation and newly treated with edoxaban or apixaban between 2015 and 2021. Cohort entry was defined as the first prescription for one of the 2 drugs. We used propensity score fine stratification and weighting for confounding adjustment. A weighted Cox proportional hazards model was used to estimate the hazard ratios (HR) with 95% CI of ischemic stroke/transient ischemic attack/systemic embolism (primary effectiveness outcome) and of major bleeding (primary safety outcome) associated with edoxaban compared with apixaban. We also assessed the risk of all-cause mortality and a composite outcome of ischemic stroke/transient ischemic attack, systemic embolism, gastrointestinal bleeding, and intracranial hemorrhage as secondary outcomes.

RESULTS

The cohort included 7251 new-users of edoxaban and 39 991 of apixaban. Edoxaban and apixaban had similar incidence rates of thromboembolism (adjusted rates, 20.38 versus 19.22 per 1000 person-years; adjusted HR, 1.06 [95% CI, 0.89-1.26]), although the rates of major bleeding were higher with edoxaban (adjusted rates, 45.57 versus 31.21 per 1000 person-years; adjusted HR, 1.42 [95% CI, 1.26-1.61]). The risk of the composite outcome was 21% higher with edoxaban (adjusted HR, 1.21 [95% CI, 1.07-1.38]). All-cause mortality was similar between edoxaban and apixaban (adjusted HR, 1.04 [95% CI, 0.96-1.12]).

CONCLUSIONS

In very elderly patients with nonvalvular atrial fibrillation, edoxaban resulted in similar thromboembolism prevention as apixaban, although it was associated with a higher risk of major bleeding. These findings may improve the management of nonvalvular atrial fibrillation by informing physicians on the choice of anticoagulant for this vulnerable population.

摘要

背景

高龄(≥80岁)人群发生非瓣膜性心房颤动和血栓栓塞的风险较高。鉴于依度沙班最近已获批准,但其在该人群中相对于常用的阿哌沙班的有效性和安全性仍不明确。

方法

利用英国临床实践研究数据链,我们确定了一组年龄≥80岁、发生非瓣膜性心房颤动且在2015年至2021年间开始接受依度沙班或阿哌沙班治疗的患者队列。队列进入定义为首次开具这两种药物之一的处方。我们使用倾向评分精细分层和加权进行混杂因素调整。采用加权Cox比例风险模型来估计与阿哌沙班相比,依度沙班相关的缺血性卒中/短暂性脑缺血发作/全身性栓塞(主要有效性结局)和大出血(主要安全性结局)风险比(HR)及95%置信区间(CI)。我们还评估了全因死亡率以及缺血性卒中/短暂性脑缺血发作、全身性栓塞、胃肠道出血和颅内出血的复合结局作为次要结局的风险。

结果

该队列包括7251名依度沙班新使用者和39991名阿哌沙班新使用者。依度沙班和阿哌沙班的血栓栓塞发生率相似(校正率分别为每1000人年20.38例和19.22例;校正HR为1.06 [95%CI,0.89 - 1.26]),尽管依度沙班的大出血发生率更高(校正率分别为每1000人年45.57例和31.21例;校正HR为1.42 [95%CI,1.26 - 1.61])。依度沙班的复合结局风险高21%(校正HR为1.21 [95%CI,1.07 - 1.38])。依度沙班和阿哌沙班的全因死亡率相似(校正HR为1.04 [95%CI,0.96 - 1.12])。

结论

在高龄非瓣膜性心房颤动患者中,依度沙班预防血栓栓塞的效果与阿哌沙班相似,尽管其大出血风险较高。这些发现可为医生为这一脆弱人群选择抗凝药物提供参考,从而改善非瓣膜性心房颤动的管理。

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