房颤缺血性卒中后每日1次与每日2次直接口服抗凝剂——ELAN试验的事后分析

IF 4.5 3区医学 Q1 CLINICAL NEUROLOGY

European Stroke Journal Pub Date : 2025-08-11 DOI:10.1177/23969873251360974

Alexandros A Polymeris, Jean-Benoît Rossel, Masatoshi Koga, Daniel Strbian, Adhiyaman Vedamurthy, Manju Krishnan, Mattia Branca, Thomas Meinel, Espen Saxhaug Kristoffersen, Takeshi Yoshimoto, Kanta Tanaka, Takenobu Kunieda, Yusuke Yakushiji, Jochen Vehoff, Kosuke Matsuzono, Peter Slade, Jelle Demeestere, Alexander Salerno, Nicoletta G Caracciolo, Dimitri Hemelsoet, Stefan T Engelter, Elias Auer, Thomas Horvath, David J Seiffge, Martina Goeldlin, Jesse Dawson, Urs Fischer

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引用次数: 0

摘要

心房颤动（AF）相关的缺血性卒中后每日一次直接口服抗凝剂（DOAC）与每日两次直接口服抗凝剂（DOAC）的风险-获益情况是否不同尚不清楚。我们在ELAN试验数据（NCT03148457）的事后分析中探讨了这一点。患者及方法：我们使用Firth logistic和Cox比例风险回归，比较了af相关卒中后每日1次或每日2次DOAC治疗的参与者从治疗开始到试验90天随访期间的主要结局（复发性缺血性卒中、全身栓塞、颅内出血（ICH）、主要颅外出血、血管性死亡）的风险。处理加权逆概率和增强逆概率加权模型来处理混淆。次要结局为主要结局成分和非大出血。通过从每日两次DOAC可能预防的过量缺血事件的比率中减去每日两次DOAC导致的过量出血的加权比率，我们计算了每日两次DOAC与每日一次DOAC的净临床获益（NCB）。结果：我们分析了1890/2013名（94%）参与者（中位年龄77岁，45%女性），其中384名（20%）接受每日一次DOAC， 1506名（80%）接受每日两次DOAC。主要结局发生在64名（3.4%）参与者中，并且在DOAC类型之间没有差异(ORunadjusted 0.89 (95% CI 0.50-1.66)；ORweighted 1.34 (0.71-2.79)；ORaugmented 1.45 (0.81-3.21)；每日两次DOAC vs每日一次DOAC)， Cox模型中也没有。我们没有发现任何次要结局的明显差异。NCB分析显示，每日两次DOAC与每日一次DOAC的净效应接近中性（对于ICH权重为1.5-3.3的患者，每100人月可能预防的加权事件+0.28至+0.67）。讨论和结论：房颤相关的缺血性卒中后每日一次DOAC与每日两次DOAC的风险-收益情况似乎没有差异。

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Once- versus twice-daily direct oral anticoagulants after ischemic stroke in atrial fibrillation - A post-hoc analysis of the ELAN trial.

Introduction: Whether the risk-benefit profile of once-daily versus twice-daily direct oral anticoagulants (DOAC) differs after atrial fibrillation(AF)-associated ischemic stroke is unclear. We explored this in a post-hoc analysis of ELAN trial data (NCT03148457).

Patients and methods: We compared the risk of the primary outcome (recurrent ischemic stroke, systemic embolism, intracranial hemorrhage (ICH), major extracranial bleeding, vascular death) from treatment initiation to the trial's 90-day follow-up in participants treated with once-daily or twice-daily DOAC after AF-associated stroke using Firth's logistic and Cox proportional hazards regression in unadjusted, inverse-probability-of-treatment-weighted and augmented-inverse-probability-weighted models to address confounding. Secondary outcomes were the primary outcome components and non-major bleeding. We calculated the net clinical benefit (NCB) of twice-daily over once-daily DOAC by subtracting the weighted rate of excess bleeding attributable to twice-daily DOAC from the rate of excess ischemic events possibly prevented by twice-daily DOAC.

Results: We analyzed 1890/2013 (94%) participants (median age 77 years, 45% female), of whom 384 (20%) received once-daily and 1506 (80%) twice-daily DOAC. The primary outcome occurred in 64 (3.4%) participants, and did not differ between DOAC types in logistic (OR_unadjusted 0.89 (95% CI 0.50-1.66); OR_weighted 1.34 (0.71-2.79); OR_augmented 1.45 (0.81-3.21); twice-daily vs once-daily DOAC) nor in Cox models. We identified no clear differences in any secondary outcome. NCB analysis revealed a near-neutral net effect of twice-daily versus once-daily DOAC (+0.28 to +0.67 weighted events possibly prevented/100 person-months for ICH weights 1.5-3.3).

Discussion and conclusion: The risk-benefit profile of once-daily versus twice-daily DOAC after AF-associated ischemic stroke does not seem to differ.

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来源期刊

European Stroke Journal Multiple-

CiteScore

7.50

自引率

6.60%

发文量

102

期刊介绍： Launched in 2016 the European Stroke Journal (ESJ) is the official journal of the European Stroke Organisation (ESO), a professional non-profit organization with over 1,400 individual members, and affiliations to numerous related national and international societies. ESJ covers clinical stroke research from all fields, including clinical trials, epidemiology, primary and secondary prevention, diagnosis, acute and post-acute management, guidelines, translation of experimental findings into clinical practice, rehabilitation, organisation of stroke care, and societal impact. It is open to authors from all relevant medical and health professions. Article types include review articles, original research, protocols, guidelines, editorials and letters to the Editor. Through ESJ, authors and researchers have gained a new platform for the rapid and professional publication of peer reviewed scientific material of the highest standards; publication in ESJ is highly competitive. The journal and its editorial team has developed excellent cooperation with sister organisations such as the World Stroke Organisation and the International Journal of Stroke, and the American Heart Organization/American Stroke Association and the journal Stroke. ESJ is fully peer-reviewed and is a member of the Committee on Publication Ethics (COPE). Issues are published 4 times a year (March, June, September and December) and articles are published OnlineFirst prior to issue publication.