急性后循环卒中患者静脉内使用阿替普酶与替奈普酶的比较：来自 AcT 随机对照试验的二次分析。

Intravenous alteplase versus tenecteplase in patients with acute posterior circulation strokes: A secondary analysis from the AcT randomized controlled trial.

机构信息

Department of Radiology, University of Calgary, Calgary, Canada; Universitätsinstitut für Diagnostische und Interventionelle Neuroradiologie, Universitätsspital Bern, Rosenbühlgasse 25, Bern 3010, Switzerland; Department of Clinical Neurosciences, University of Calgary, Calgary, Canada.

Department of Clinical Neurosciences, University of Calgary, Calgary, Canada.

出版信息

J Stroke Cerebrovasc Dis. 2024 Nov;33(11):107985. doi: 10.1016/j.jstrokecerebrovasdis.2024.107985. Epub 2024 Aug 31.

DOI:10.1016/j.jstrokecerebrovasdis.2024.107985

PMID:39222700

Abstract

OBJECTIVES

There are limited data available demonstrating the safety and efficacy of intravenous tenecteplase versus alteplase in patients with acute ischemic stroke in the posterior circulation.

MATERIALS AND METHODS

This is a post-hoc analysis of the Alteplase compared to Tenecteplase (AcT) pragmatic, phase 3, registry-linked randomized controlled trial. Patients with any posterior circulation vessel occlusion on baseline imaging were included. Study outcomes included 90-day modified Rankin Scale (mRS) 0-1, mRS 0-2, ordinal mRS, death within 90 days, 24 h symptomatic intracerebral haemorrhage (sICH) and successful reperfusion/recanalization. Mixed effects regression adjusting for age, sex and stroke severity was used to analyze differences in outcomes between patients administered tenecteplase vs. alteplase. Further, sensitivity analysis was conducted for basilar artery occlusion (BAO) alone.

RESULTS

Of 1577 patients, 136 (8.6 %, 77:alteplase, 59:tenecteplase) had posterior circulation stroke. Baseline characteristics were similar[median age 71 (IQR 60-81) vs. 72 (IQR 65-82) years, 57.1 % vs. 67.8 % males, median baseline NIHSS 7 (IQR 4-12) vs. 7 (IQR 4-16) in alteplase vs. tenecteplase arms, respectively]. 28 patients (20.6 %, 16:alteplase, 12:tenecteplase arm) underwent EVT. The median 90-120 days mRS was 2 (IQR 1-4). There were no differences between alteplase and tenecteplase for 90-d mRS 0-1 (adjRR 0.93;95 %CI 0.63-1.36), 90-day mRS 0-2 (adjRR 0.95; 95 %CI 0.72-1.26), sICH (RR 0.65; 95 %CI 0.06-7.02) and mortality (RR 1.21; 95 %CI 0.61-2.38). Successful reperfusion eTICI 2b-3 and successful recanalization rAOL 2b-3 was achieved in 23/28 (82 %, 12:alteplase, 11:tenecteplase) and in 16/28 (57 %, 14:alteplase, 12:tenecteplase), respectively. Similar results were seen in 31 patients (22.8 %) with BAO.

CONCLUSION

Intravenous tenecteplase has a similar effect on outcome as alteplase, without increased safety concerns in patients with acute posterior circulation strokes.

摘要

目的

目前可用的数据有限，无法证明急性缺血性脑卒中后循环患者静脉内使用替奈普酶与阿替普酶的安全性和有效性。

材料和方法

这是一项阿替普酶与替奈普酶（AcT）实用性、3 期、登记相关随机对照试验的事后分析。纳入基线影像学上存在任何后循环血管闭塞的患者。研究结局包括 90 天改良 Rankin 量表（mRS）0-1、mRS 0-2、mRS 等级、90 天内死亡、24 小时症状性颅内出血（sICH）和再通/再通成功。采用混合效应回归，调整年龄、性别和卒中严重程度，分析替奈普酶与阿替普酶治疗患者之间结局的差异。进一步对基底动脉闭塞（BAO）单独进行敏感性分析。

结果

在 1577 例患者中，136 例（8.6%，77：阿替普酶，59：替奈普酶）存在后循环卒中。基线特征相似[中位年龄 71（IQR 60-81）岁比 72（IQR 65-82）岁，57.1%比 67.8%为男性，中位基线 NIHSS 7（IQR 4-12）分比 7（IQR 4-16）分，分别在阿替普酶和替奈普酶组]。28 例患者（20.6%，16：阿替普酶，12：替奈普酶组）接受了 EVT。中位 90-120 天 mRS 为 2（IQR 1-4）。阿替普酶和替奈普酶组 90 天 mRS 0-1（调整 RR 0.93；95%CI 0.63-1.36）、90 天 mRS 0-2（调整 RR 0.95；95%CI 0.72-1.26）、sICH（RR 0.65；95%CI 0.06-7.02）和死亡率（RR 1.21；95%CI 0.61-2.38）均无差异。28 例患者中，23 例（82%，12：阿替普酶，11：替奈普酶）和 16 例（57%，14：阿替普酶，12：替奈普酶）分别达到 eTICI 2b-3 级再通和 rAOL 2b-3 级再通。31 例（22.8%）基底动脉闭塞患者也有类似结果。