替罗非班在症状性颅内动脉粥样硬化狭窄支架置入术前的疗效和安全性：一项随机临床试验。

Efficacy and Safety of Tirofiban Before Stenting for Symptomatic Intracranial Atherosclerotic Stenosis: A Randomized Clinical Trial.

机构信息

From the Departments of Neurology (J.Z., L.S., Y.S., W.Z., M.Z., Y.M., H.Y., W.W., J.H.) and Clinical Pharmacy (X.H.), The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Jinan; Department of Neurology (G.W.), Binzhou People's Hospital; Department of Neurology (X.W.), Linyi People's Hospital; Department of Neurology (T.Z.), The First Hospital of Zibo; Department of Neurology (D.W.), Weifang Hospital of Traditional Chinese Medicine; Department of Neurology (L.Q.), Liaocheng People's Hospital; Department of Neurology (J.L.), Yucheng People's Hospital, Dezhou; Department of Neurology (B.L.), Yantai Yuhuangding Hospital; Department of Neurology (J.C.), Jining First People's Hospital; and Department of Neurology (K.L.), Heze Municipal Hospital, China.

出版信息

Neurology. 2024 Apr 9;102(7):e209217. doi: 10.1212/WNL.0000000000209217. Epub 2024 Mar 15.

DOI:10.1212/WNL.0000000000209217

PMID:38489544

Abstract

BACKGROUND AND OBJECTIVES

Acute stent thrombosis (AST) is not uncommon and even catastrophic during intracranial stenting angioplasty in patients with symptomatic high-grade intracranial atherosclerotic stenosis (ICAS). The purpose of this study was to investigate whether adjuvant intravenous tirofiban before stenting could reduce the risk of AST and periprocedural ischemic stroke in patients receiving stent angioplasty for symptomatic ICAS.

METHODS

A prospective, multicenter, open-label, randomized clinical trial was conducted from September 9, 2020, to February 18, 2022, at 10 medical centers in China. Patients intended to receive stent angioplasty for symptomatic high-grade ICAS were enrolled and randomly assigned to receive intravenous tirofiban or not before stenting in a 1:1 ratio. The primary outcomes included the incidence of AST within 30 minutes after stenting, periprocedural new-onset ischemic stroke, and symptomatic intracranial hemorrhage. The outcomes were analyzed using logistic regression analysis to obtain an odds ratio and 95% confidence interval.

RESULTS

A total of 200 participants (122 men [61.0%]; median [interquartile ranges] age, 57 [52-66] years) were included in the analysis, with 100 participants randomly assigned to the tirofiban group and 100 participants to the control (no tirofiban) group. The AST incidence was lower in the tirofiban group than that in the control group (4.0% vs 14.0%; adjusted odds ratio, 0.25; 95% CI 0.08-0.82; 0.02). No significant difference was observed in the incidence of periprocedural ischemic stroke (7.0% vs 8.0%; 0.98) or symptomatic intracranial hemorrhage between the 2 groups.

DISCUSSION

This study suggests that adjuvant intravenous tirofiban before stenting could lower the risk of AST during stent angioplasty in patients with symptomatic high-grade ICAS.

TRIAL REGISTRATION INFORMATION

URL: chictr.org.cn; Unique identifier: ChiCTR2000031935.

CLASSIFICATION OF EVIDENCE

This study provides Class II evidence that for patients with symptomatic high-grade ICAS, pretreatment with tirofiban decreases the incidence of acute stent thrombosis. This study is Class II due to the unequal distribution of involved arteries between the 2 groups.

摘要

背景与目的

在有症状的颅内动脉粥样硬化性狭窄（ICAS）患者的颅内支架血管成形术中，急性支架内血栓形成（AST）并不少见，甚至是灾难性的。本研究旨在探讨支架置入前辅助静脉注射替罗非班是否可以降低接受支架血管成形术治疗有症状的 ICAS 患者的 AST 和围手术期缺血性卒中风险。

方法

这是一项于 2020 年 9 月 9 日至 2022 年 2 月 18 日在中国 10 家医疗中心进行的前瞻性、多中心、开放标签、随机临床试验。纳入了计划接受支架血管成形术治疗有症状的重度 ICAS 的患者，并以 1:1 的比例随机分配至支架置入前接受或不接受静脉注射替罗非班。主要结局包括支架置入后 30 分钟内 AST 的发生率、围手术期新发缺血性卒中和症状性颅内出血。采用 logistic 回归分析获得比值比和 95%置信区间，对结局进行分析。

结果

共有 200 名参与者（122 名男性[61.0%]；中位[四分位间距]年龄为 57[52-66]岁）纳入分析，100 名参与者随机分配至替罗非班组，100 名参与者分配至对照组（无替罗非班）。替罗非班组 AST 发生率低于对照组（4.0%比 14.0%；调整后比值比为 0.25；95%CI 0.08-0.82；P=0.02）。两组围手术期缺血性卒中和症状性颅内出血的发生率无显著差异（7.0%比 8.0%；P=0.98）。