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替罗非班用于血管内血栓切除术治疗大血管闭塞性卒中静脉溶栓适用患者的疗效和安全性:来自 DIRECT-MT 试验的事后分析。

The Efficacy and Safety of Tirofiban Use in Endovascular Thrombectomy for Intravenous Thrombolysis Applicable Patients with Large Vessel Occlusion Stroke-a Post Hoc Analysis from the Direct-MT Trial.

机构信息

Department of Neurology, Fudan University Zhongshan Hospital, Shanghai, China.

Department of Neurovascular Center, Naval Medical University Changhai Hospital, Shanghai, China.

出版信息

Cardiovasc Intervent Radiol. 2024 Feb;47(2):208-215. doi: 10.1007/s00270-023-03540-9. Epub 2023 Oct 5.

Abstract

PURPOSE

The purpose of the study was to evaluate the efficacy and safety of tirofiban use in endovascular thrombectomy for intravenous thrombolysis applicable patients of large vessel occlusion stroke with data from Direct-MT trial.

MATERIALS AND METHODS

Direct-MT was the first randomized controlled trial to prove the non-inferiority of thrombectomy alone to bridging therapy (intravenous thrombolysis before thrombectomy) for large vessel occlusion stroke. Patients who underwent endovascular procedure were included and divided into thrombectomy-alone group and bridging therapy group. The effect of tirofiban use on 90 days MRS distribution, MRS 0-2 and mortality, successful reperfusion, the ASPECTS and outcome lesion volume of index stroke, re-occlusion of the treated vessel, futile recanalization and safety outcomes were further evaluated in both groups after adjustment for relevant confounding factors. The interaction between tirofiban and rt-PA was also assessed.

RESULTS

Of 639 patients included in this analysis, 180 patients underwent thrombectomy with tirofiban use (28.2%). Patients with tirofiban use had lower percentage of bridging therapy (41.1% vs 54.3%, P = 0.003), higher proportion of large artery atherosclerosis (P < 0.001) and more emergent stenting (30.56% vs 6.97%, P < 0.001). After adjustment for confounding factors, the 90-day modified Rankin Scale distribution, successful final recanalization rate, outcome lesion volume of index stroke on CT and intracranial hemorrhage risk showed no difference after tirofiban use in thrombectomy-alone group and in bridging therapy group. No interaction effect between tirofiban and rt-PA was detected.

CONCLUSION

Based on data from Direct-MT trial, tirofiban is a safe medication for intravenous thrombolysis applicable patients with large vessel occlusion stroke undergoing thrombectomy.

LEVEL OF EVIDENCE

Level 3, cohort study of randomized trial.

摘要

目的

本研究旨在评估替罗非班在直接机械取栓治疗急性大血管闭塞性卒中患者中的有效性和安全性,试验数据来自 Direct-MT 研究。

材料与方法

Direct-MT 是首个证明单纯取栓不劣于桥接治疗(取栓前溶栓)的随机对照研究,本研究纳入接受血管内治疗的患者,分为单纯取栓组和桥接治疗组。调整相关混杂因素后,进一步评估替罗非班对 90 天 mRS 分布、mRS0-2 及死亡率、血管再通成功、基线 ASPECTS 评分和梗死核心体积、治疗血管再闭塞、无效再通及安全性结局的影响,并评估替罗非班与 rt-PA 的交互作用。

结果

本分析共纳入 639 例患者,其中 180 例行替罗非班辅助取栓(28.2%)。替罗非班组桥接治疗比例更低(41.1%比 54.3%,P=0.003),大动脉粥样硬化比例更高(P<0.001),紧急支架植入术更多(30.56%比 6.97%,P<0.001)。调整混杂因素后,替罗非班在单纯取栓组和桥接治疗组中应用,90 天 mRS 分布、最终血管再通率、基线 CT 梗死核心体积和颅内出血风险无差异。未检测到替罗非班与 rt-PA 的交互作用。

结论

基于 Direct-MT 研究数据,替罗非班是一种安全的药物,可用于接受取栓治疗的急性大血管闭塞性卒中患者。

证据等级

3 级,随机临床试验的队列研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/58e6/10844137/46350720cdb1/270_2023_3540_Fig1_HTML.jpg

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