Efficacy and safety of intravenous alteplase for unknown onset stroke on prior antiplatelet therapy: Post hoc analysis of the EOS individual participant data.

IF 8.7 2区医学 Q1 CLINICAL NEUROLOGY

International Journal of Stroke Pub Date : 2025-07-01 Epub Date: 2025-02-27 DOI:10.1177/17474930251322034

Yuma Shiomi, Kaori Miwa, Märit Jensen, Manabu Inoue, Sohei Yoshimura, Naruhiko Kamogawa, Mayumi Fukuda-Doi, Henry Ma, Peter Ringleb, Ona Wu, Lee H Schwamm, Stephen M Davis, Geoffrey A Donnan, Christian Gerloff, Jin Nakahara, Kazunori Toyoda, Götz Thomalla, Masatoshi Koga

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引用次数: 0

Abstract

Background: The effects of intravenous alteplase in patients with prior antiplatelet therapy (APT) remain controversial. We aimed to assess the efficacy and safety of imaging-based intravenous alteplase in patients with unknown onset stroke with prior APT.

Methods: Data from randomized controlled trials comparing alteplase with placebo/standard care in patients with unknown onset acute ischemic stroke from the Evaluation of Unknown Onset Stroke Thrombolysis (EOS) individual patient data meta-analysis collaboration were analyzed. Favorable outcome was defined as a modified Rankin Scale score of 0-1 at 90 days post-stroke. Safety outcomes included symptomatic intracranial hemorrhage (sICH) at 22-36 h and 90-day mortality.

Results: Overall, 780 patients had available baseline data on prior APT. Compared with the no prior APT group (n = 523), the prior APT group (n = 257) was older (72 vs. 66 years) and had a higher prevalence of vascular risk factors. There was no interaction between prior APT and treatment effects of alteplase (p for interaction = 0.23). In the prior APT patients, 55/125 (45%) patients in the alteplase group and 39/132 (30%) patients in the control group had a favorable outcome (adjusted odds ratio [aOR], 2.07 [95% confidence interval, 1.18-3.64]). The rates of sICH and mortality in the alteplase and control groups were 5.6% and 0.8% (aOR, 7.78 [0.94-63.37]) and 6.5% and 6.1% (aOR, 1.12 [0.38-3.36]), respectively. In the no prior APT patients, 136 patients (50%) in the alteplase group and 112 patients (45%) in the control group had a favorable outcome (aOR, 1.39 [0.94-2.05]). Safety outcomes were not significantly different between the groups (sICH: 3 [1.1%] vs. 1 [0.4%]; mortality: 13 [4.9%] vs. 3 [1.2%]).

Conclusions: Alteplase has consistent efficacy regardless of prior APT in patients with unknown onset stroke. In addition, prior APT does not significantly increase the risk of sICH or mortality.

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既往抗血小板治疗后静脉注射阿替普酶治疗不明起病脑卒中的有效性和安全性：EOS个体参与者数据的事后分析

背景：静脉注射阿替普酶对既往抗血小板治疗（APT）患者的影响仍存在争议。我们的目的是评估基于成像的静脉注射阿替普酶对未知原因的卒中患者既往apt的疗效和安全性。方法：来自未知原因的卒中溶栓评估（EOS）个体患者数据荟萃分析协作的随机对照试验数据，比较阿替普酶与安慰剂/标准治疗对未知原因的急性缺血性卒中患者的疗效和安全性。卒中后90 d的改良Rankin量表评分为0-1分。安全性指标包括22-36小时症状性颅内出血（siich）和90 d死亡率。结果：总体而言，780例患者有可获得的既往APT基线数据。与无既往APT组（n=523）相比，既往APT组（n=257）年龄更大（72岁对66岁），血管危险因素患病率更高。既往APT与阿替普酶治疗效果无交互作用（交互作用p =0.23）。在既往APT患者中，阿替普酶组55/125例（45%）患者和对照组39/132例（30%）患者预后良好（调整优势比[aOR]， 2.07 [95% CI, 1.18-3.64]）。阿替普酶组和对照组sICH发生率和死亡率分别为5.6%和0.8% （aOR, 7.78[0.94-63.37]）和6.5%和6.1% （aOR, 1.12[0.38-3.36]）。在无APT患者中，阿替普酶组136例（50%）和对照组112例（45%）患者预后良好（aOR为1.39[0.94-2.05]）。两组间安全性结果无显著差异(siich: 3 [1.1%] vs. 1 [0.4%]；死亡率：13人[4.9%]vs. 3人[1.2%])。结论：阿替普酶对未知发病的卒中患者具有一致的疗效，无论是否有APT。此外，先前的APT不会显著增加sICH的风险或死亡率。

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来源期刊

International Journal of Stroke 医学-外周血管病

CiteScore

13.90

自引率

6.00%

发文量

132

审稿时长

6-12 weeks

期刊介绍： The International Journal of Stroke is a welcome addition to the international stroke journal landscape in that it concentrates on the clinical aspects of stroke with basic science contributions in areas of clinical interest. Reviews of current topics are broadly based to encompass not only recent advances of global interest but also those which may be more important in certain regions and the journal regularly features items of news interest from all parts of the world. To facilitate the international nature of the journal, our Associate Editors from Europe, Asia, North America and South America coordinate segments of the journal.