Thrombolysis for ischemic stroke at 4.5 to 24 hours: An updated meta-analysis of randomized controlled trials

IF 1.8 4区医学 Q3 NEUROSCIENCES

Journal of Stroke & Cerebrovascular Diseases Pub Date : 2025-07-29 DOI:10.1016/j.jstrokecerebrovasdis.2025.108408

Jia-Xin Luo , Zuo-qiao Li , Zi-zhen Meng , Qian Dong , Xue-yun Liu , Tian-nan Yang , Zi-jie Wang , Xiao-san Wu , Qi Li

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引用次数: 0

Abstract

Background

Only a minority of stroke patients are eligible for intravenous thrombolysis (IVT) within the standard 4.5-hour window. The safety and efficacy of IVT beyond this time frame remain insufficiently researched.

Objective

To evaluate the efficacy and safety following IVT in patients with AIS (4.5-24 hours).

Methods

The systematic review was registered in PROSPERO (CRD420251019740). Inclusion criteria included randomized clinical trials that examined outcomes, mortality, and complications in patients with AIS comparing IVT vs Best Medical Treatment (BMT). The risk of bias in the included studies was evaluated using the revised tool for assessing risk of bias. Meta-analyses assessed efficacy (excellent outcomes, functional independence) and safety (symptomatic intracranial hemorrhage [sICH], mortality) using a random-effects model.

Results

A total of six randomized clinical trials with 1884 initially enrolled patients were included in the analysis. Higher excellent outcome rates were observed in the IVT group (RR, 1.25; 95 % CI, 1.11-1.41). No significant differences were found in functional independence (RR, 1.14; 95 % CI, 0.98-1.32), sICH (RR, 1.91; 95 % CI, 0.85-4.33), or 90-day all-cause mortality (RR, 1.02; 95 % CI, 0.81-1.29). There was considerable heterogeneity among the studies included in the functional independence outcome (I² = 40.8 %, τ² = 0.01); however, no heterogeneity was observed for other outcomes (I² = 0, τ² = 0).

Conclusions and Relevance

These findings suggest that IVT with tenecteplase or alteplase may enhance 90-day excellent outcomes in patients with late-window acute ischemic stroke without significantly increasing the risk of sICH or mortality.

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4.5 - 24小时溶栓治疗缺血性卒中：一项随机对照试验的最新荟萃分析

背景：只有少数脑卒中患者有资格在标准的4.5小时内进行静脉溶栓（IVT）。IVT在这段时间之后的安全性和有效性仍然没有得到充分的研究。目的：评价AIS患者IVT治疗（4.5 ~ 24小时）的疗效和安全性。方法：系统评价在PROSPERO注册（CRD420251019740）。纳入标准包括随机临床试验，比较IVT与最佳药物治疗（BMT）对AIS患者的预后、死亡率和并发症。使用修订后的偏倚风险评估工具对纳入研究的偏倚风险进行评估。meta分析使用随机效应模型评估了疗效（良好的结局，功能独立性）和安全性（症状性颅内出血[sICH]，死亡率）。结果：共有6项随机临床试验纳入了1884例初始入组患者。IVT组的优转率较高(RR, 1.25；95% ci, 1.11-1.41)。功能独立性无显著差异(RR, 1.14；95% CI, 0.98-1.32), sICH (RR, 1.91；95% CI, 0.85-4.33)或90天全因死亡率(RR, 1.02；95% ci, 0.81-1.29)。功能独立性结局纳入的研究存在相当大的异质性（I² = 40.8%,τ² = 0.01）；然而，其他结果没有观察到异质性（I² = 0,τ² = 0）。结论和相关性：这些研究结果表明，静脉滴注替奈普酶或阿替普酶可以提高急性缺血性脑卒中晚期患者90天的良好预后，而不会显著增加sICH或死亡率的风险。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Stroke & Cerebrovascular Diseases Medicine-Surgery

CiteScore

5.00

自引率

4.00%

发文量

583

审稿时长

62 days

期刊介绍： The Journal of Stroke & Cerebrovascular Diseases publishes original papers on basic and clinical science related to the fields of stroke and cerebrovascular diseases. The Journal also features review articles, controversies, methods and technical notes, selected case reports and other original articles of special nature. Its editorial mission is to focus on prevention and repair of cerebrovascular disease. Clinical papers emphasize medical and surgical aspects of stroke, clinical trials and design, epidemiology, stroke care delivery systems and outcomes, imaging sciences and rehabilitation of stroke. The Journal will be of special interest to specialists involved in caring for patients with cerebrovascular disease, including neurologists, neurosurgeons and cardiologists.