Risk of Hemorrhagic Transformation after Mechanical Thrombectomy without versus with IV Thrombolysis for Acute Ischemic Stroke: A Systematic Review and Meta-analysis of Randomized Clinical Trials.

Seyed Behnam Jazayeri, Sherief Ghozy, Lina Hemmeda, Cem Bilgin, Mohamed Elfil, Ramanathan Kadirvel, David F Kallmes
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Abstract

Background: When treating acute ischemic stroke due to large-vessel occlusion, both mechanical thrombectomy and intravenous (IV) thrombolysis carry the risk of intracerebral hemorrhage.

Purpose: This study aimed to delve deeper into the risk of intracerebral hemorrhage and its subtypes associated with mechanical thrombectomy with or without IV thrombolysis to contribute to better decision-making in the treatment of acute ischemic stroke due to large-vessel occlusion.

Data sources: PubMed, EMBASE, and Scopus databases were searched for relevant studies from inception to September 6, 2023.

Study selection: The eligibility criteria included randomized clinical trials or post hoc analysis of randomized controlled trials that focused on patients with acute ischemic stroke in the anterior circulation. After screening 4870 retrieved records, we included 9 studies (6 randomized controlled trials and 3 post hoc analyses of randomized controlled trials) with 3241 patients.

Data analysis: The interventions compared were mechanical thrombectomy + IV thrombolysis versus mechanical thrombectomy alone, with the outcome of interest being any form of intracerebral hemorrhage and symptomatic intracerebral hemorrhage after intervention. A common definition for symptomatic intracerebral hemorrhage was pooled from various classification systems, and subgroup analyses were performed on the basis of different definitions and anatomic descriptions of hemorrhage. The quality of the studies was assessed using the revised version of Cochrane Risk of Bias 2 assessment tool. Meta-analysis was performed using the random effects model.

Data synthesis: Eight studies had some concerns, and 1 study was considered high risk. Overall, the risk of symptomatic intracerebral hemorrhage was comparable between mechanical thrombectomy + IV thrombolysis and mechanical thrombectomy alone (risk ratio, 1.24 [95% CI, 0.89-1.72]; P = .20), with no heterogeneity across studies. Subgroup analysis of symptomatic intracerebral hemorrhage showed a non-significant difference between 2 groups based on the National Institute of Neurological Disorders and Stroke (P = .3), the Heidelberg Bleeding Classification (P = .5), the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (P = .4), and the European Cooperative Acute Stroke Study III (P = .7) criteria. Subgroup analysis of different anatomic descriptions of intracerebral hemorrhage showed no difference between the 2 groups. Also, we found no difference in the risk of any intracerebral hemorrhage between two groups (risk ratio, 1.10 [95% CI, 1.00-1.21]; P = .052) with no heterogeneity across studies.

Limitations: There was a potential for performance bias in most studies.

Conclusions: In this systematic review and meta-analysis, the risk of any intracerebral hemorrhage and symptomatic intracerebral hemorrhage, including its various classifications and anatomic descriptions, was comparable between mechanical thrombectomy + IV thrombolysis and mechanical thrombectomy alone.

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急性缺血性脑卒中机械取栓术后出血转化风险与静脉溶栓术后出血转化风险的比较:随机临床试验的系统回顾和元分析》。
背景:目的:本研究旨在深入探讨机械取栓联合或不联合静脉溶栓治疗急性大血管闭塞性缺血性卒中的脑出血风险及其亚型,以便在治疗急性大血管闭塞性缺血性卒中时做出更好的决策:检索了PubMed、EMBASE和Scopus数据库中从开始到2023年9月6日的相关研究:资格标准包括针对前循环急性缺血性卒中患者的随机临床试验或随机对照试验的事后分析。在筛选了 4870 份检索记录后,我们纳入了 9 项研究(6 项随机对照试验和 3 项随机对照试验的事后分析),共 3241 名患者:数据分析:比较的干预措施是机械性血栓切除术+静脉溶栓与单纯机械性血栓切除术,关注的结果是任何形式的脑内出血和干预后的无症状脑内出血。从不同的分类系统中汇集了症状性脑出血的通用定义,并根据不同的出血定义和解剖学描述进行了亚组分析。研究质量采用 Cochrane Risk of Bias 2 评估工具的修订版进行评估。采用随机效应模型进行 Meta 分析:8项研究存在一些问题,1项研究被视为高风险研究。总体而言,机械取栓术+静脉溶栓与单纯机械取栓术的症状性脑出血风险相当(风险比为1.24 [95% CI, 0.89-1.72];P = .20),各研究间无异质性。对无症状性脑出血进行的亚组分析显示,根据美国国立神经疾病与中风研究所(National Institute of Neurological Disorders and Stroke)(P = .3)、海德堡出血分类(Heidelberg Bleeding Classification)(P = .5)、中风溶栓安全实施监测研究(Safe Implementation of Thrombolysis in Stroke-Monitoring Study)(P = .4)和欧洲急性中风合作研究 III(European Cooperative Acute Stroke Study III)(P = .7)的标准,两组之间的差异不显著。对不同解剖学描述的脑内出血进行的亚组分析表明,两组之间没有差异。此外,我们还发现两组间发生任何脑内出血的风险没有差异(风险比为 1.10 [95% CI, 1.00-1.21];P = .052),且各研究间无异质性:局限性:大多数研究可能存在表现偏倚:在这项系统回顾和荟萃分析中,机械取栓术+静脉溶栓与单纯机械取栓术发生任何脑内出血和症状性脑内出血(包括各种分类和解剖描述)的风险相当。
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