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低剂量替罗非班联合静脉溶栓及机械取栓治疗急性缺血性卒中的安全性和有效性:一项来自全国性登记研究的匹配对照分析

Safety and Efficacy of Low-Dose Tirofiban Combined With Intravenous Thrombolysis and Mechanical Thrombectomy in Acute Ischemic Stroke: A Matched-Control Analysis From a Nationwide Registry.

作者信息

Ma Gaoting, Li Shuo, Jia Baixue, Mo Dapeng, Ma Ning, Gao Feng, Huo Xiaochuan, Luo Gang, Wang Anxin, Pan Yuesong, Song Ligang, Sun Xuan, Zhang Xuelei, Gui Liqiang, Song Cunfeng, Peng Ya, Wu Jin, Zhao Shijun, Zhao Junfeng, Zhou Zhiming, Miao Zhongrong

机构信息

Interventional Neuroradiology Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.

Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.

出版信息

Front Neurol. 2021 Jun 10;12:666919. doi: 10.3389/fneur.2021.666919. eCollection 2021.

Abstract

Tirofiban administration to acute ischemic stroke patients undergoing mechanical thrombectomy with preceding intravenous thrombolysis remains controversial. The aim of the current study was to evaluate the safety and efficacy of low-dose tirofiban during mechanical thrombectomy in patients with preceding intravenous thrombolysis. Patients with acute ischemic stroke undergoing mechanical thrombectomy and preceding intravenous thrombolysis were derived from "ANGEL-ACT," a multicenter, prospective registry study. The patients were dichotomized into tirofiban and non-tirofiban groups based on whether tirofiban was administered. Propensity score matching was used to minimize case bias. The primary safety endpoint was symptomatic intracerebral hemorrhage (sICH), defined as an intracerebral hemorrhage (ICH) associated with clinical deterioration as determined by the Heidelberg Bleeding Classification. All ICHs and hemorrhage types were recorded. Clinical outcomes included successful recanalization, dramatic clinical improvement, functional independence, and mortality at the 3-month follow-up timepoint. Successful recanalization was defined as a modified Thrombolysis in Cerebral Ischemia score of 2b or 3. Dramatic clinical improvement at 24 h was defined as a reduction in NIH stroke score of ≥10 points compared with admission, or a score ≤1. Functional independence was defined as a Modified Rankin Scale (mRS) score of 0-2 at 3-months. The study included 201 patients, 81 in the tirofiban group and 120 in the non-tirofiban group, and each group included 68 patients after propensity score matching. Of the 201 patients, 52 (25.9%) suffered ICH, 15 (7.5%) suffered sICH, and 18 (9.0%) died within 3-months. The median mRS was 3 (0-4), 99 (49.3%) achieved functional independence. There were no statistically significant differences in safety outcomes, efficacy outcomes on successful recanalization, dramatic clinical improvement, or 3-month mRS between the tirofiban and non-tirofiban groups (all > 0.05). Similar results were obtained after propensity score matching. In acute ischemic stroke patients who underwent mechanical thrombectomy and preceding intravenous thrombolysis, low-dose tirofiban was not associated with increased risk of sICH or ICH. Further randomized clinical trials are needed to confirm the effects of tirofiban in patients undergoing bridging therapy.

摘要

在接受静脉溶栓治疗后进行机械取栓的急性缺血性卒中患者中使用替罗非班仍存在争议。本研究的目的是评估在接受静脉溶栓治疗的患者进行机械取栓期间使用低剂量替罗非班的安全性和有效性。接受机械取栓且之前接受静脉溶栓治疗的急性缺血性卒中患者来自“ANGEL-ACT”,这是一项多中心前瞻性注册研究。根据是否使用替罗非班,将患者分为替罗非班组和非替罗非班组。采用倾向评分匹配以尽量减少病例偏倚。主要安全终点是症状性脑出血(sICH),定义为根据海德堡出血分类法确定的与临床恶化相关的脑出血(ICH)。记录所有脑出血及出血类型。临床结局包括成功再通、显著临床改善、功能独立以及3个月随访时间点的死亡率。成功再通定义为脑缺血溶栓改良评分2b或3分。24小时时的显著临床改善定义为与入院时相比美国国立卫生研究院卒中量表评分降低≥10分,或评分≤1分。功能独立定义为3个月时改良Rankin量表(mRS)评分为0 - 2分。该研究纳入201例患者,替罗非班组81例,非替罗非班组120例,倾向评分匹配后每组各有68例患者。在这201例患者中,52例(25.9%)发生脑出血,15例(7.5%)发生症状性脑出血,18例(9.0%)在3个月内死亡。mRS中位数为3(0 - 4),99例(49.3%)实现功能独立。替罗非班组和非替罗非班组在安全结局、成功再通的疗效结局、显著临床改善或3个月mRS方面均无统计学显著差异(均>0.05)。倾向评分匹配后得到了类似结果。在接受机械取栓且之前接受静脉溶栓治疗的急性缺血性卒中患者中,低剂量替罗非班与症状性脑出血或脑出血风险增加无关。需要进一步的随机临床试验来证实替罗非班在接受桥接治疗患者中的效果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d61/8225265/1dc46daf3263/fneur-12-666919-g0001.jpg

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