Department of Neurology, Chang Gung University College of Medicine, Chang Gung Memorial Hospital, Chiayi Branch, Puzi, Taiwan.
Department of Neurology and Stroke Center, University of California, Los Angeles (UCLA), Los Angeles, California, USA.
J Neurointerv Surg. 2022 Mar;14(3):227-232. doi: 10.1136/neurintsurg-2021-017667. Epub 2021 Jul 15.
To conduct a meta-analysis of randomized trials to comprehensively compare the effect of endovascular thrombectomy (EVT) versus intravenous thrombolysis (IVT) plus EVT on functional independence (modified Rankin Scale (mRS) 0-2) after acute ischemic stroke due to large vessel occlusions (AIS-LVO).
We searched Pubmed, EMBASE, CENTRAL, and clinicaltrials.gov from January 2000 to February 2021 and abstracts presented at the International Stroke Conference in March 2021 to identify trials comparing EVT alone versus IVT plus EVT in AIS-LVO. Five non-inferiority margins established in the literature were assessed: -15%, -10%, -6.5%, -5%, and -1.3% for the risk difference for functional independence at 90 days.
Four trials met the selection criteria, enrolling 1633 individuals, with 817 participants randomly assigned to EVT alone and 816 to IVT plus EVT. Crude cumulative rates of 90-day functional independence were 46.0% with EVT alone versus 45.5% with IVT plus EVT. Pooled results showed the risk difference of functional independence was 1% (95% CI -4% to 5%) between EVT alone versus IVT plus EVT. The lower 95% CI bound of -4% fell within the non-inferiority margins of -15%, -10%, -6.5%, and -5%, but not -1.3%. Pooled results also showed the risk difference between EVT alone versus IVT plus EVT was 1% (95% CI -3% to 5%) for mRS 0-1, and 1% (95% CI -1% to 3%) for symptomatic intracranial hemorrhage.
This meta-analysis suggests that EVT alone is non-inferior to IVT plus EVT for several, but not the most stringent, non-inferiority margins.
对随机试验进行荟萃分析，全面比较血管内血栓切除术（EVT）与静脉溶栓（IVT）加 EVT 治疗大动脉闭塞性急性缺血性脑卒中（AIS-LVO）后功能独立性（改良 Rankin 量表（mRS）0-2）的效果。
我们检索了 2000 年 1 月至 2021 年 2 月的 Pubmed、EMBASE、CENTRAL 和 clinicaltrials.gov，并检索了 2021 年 3 月国际卒中大会的摘要，以确定比较单独 EVT 与 IVT 加 EVT 治疗 AIS-LVO 的试验。评估了文献中确定的 5 个非劣效性边界：90 天功能独立的风险差异为-15%、-10%、-6.5%、-5%和-1.3%。
四项试验符合入选标准，共纳入 1633 例患者，817 例患者随机分配至单独 EVT 组，816 例患者分配至 IVT 加 EVT 组。单独 EVT 组 90 天功能独立的累积率为 46.0%，IVT 加 EVT 组为 45.5%。汇总结果显示，单独 EVT 与 IVT 加 EVT 之间功能独立的风险差异为 1%（95%CI-4%至 5%）。95%CI 的下限-4%落在-15%、-10%、-6.5%和-5%的非劣效性边界内，但未落在-1.3%的非劣效性边界内。汇总结果还显示，单独 EVT 与 IVT 加 EVT 之间的风险差异在 mRS 0-1 为 1%（95%CI-3%至 5%），在症状性颅内出血为 1%（95%CI-1%至 3%）。
这项荟萃分析表明，单独 EVT 在几个而非最严格的非劣效性边界上不劣于 IVT 加 EVT。
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