静脉注射替罗非班与血管内治疗前阿替普酶治疗急性缺血性脑卒中：DEVT 和 RESCUE BT 试验的汇总分析。
Intravenous Tirofiban Versus Alteplase Before Endovascular Treatment in Acute Ischemic Stroke: A Pooled Analysis of the DEVT and RESCUE BT Trials.
机构信息
Affiliated Hangzhou First People's Hospital, Westlake University School of Medicine, China (H.S., C.Y.).
Xiangyang No. 1 People's Hospital, Hubei University of Medicine, China (Z.C.).
出版信息
Stroke. 2024 Apr;55(4):856-865. doi: 10.1161/STROKEAHA.123.044562. Epub 2024 Feb 16.
BACKGROUND
The present study aimed to evaluate the efficacy and safety of intravenous tirofiban versus alteplase before endovascular treatment (EVT) in acute ischemic stroke patients with intracranial large vessel occlusion.
METHODS
This was a post hoc analysis using data from 2 multicenter, randomized trials: the DEVT trial (Direct Endovascular Treatment for Large Vessel Occlusion Stroke) from May 2018 to May 2020 and the RESCUE BT trial (Intravenous Tirofiban Before Endovascular Thrombectomy for Acute Ischemic Stroke) from October 2018 to October 2021. Patients with acute intracranial large vessel occlusion within 4.5 hours from last known well were dichotomized into 2 groups: tirofiban plus EVT versus alteplase bridging with EVT. The primary outcome was functional independence (modified Rankin Scale score of 0-2) at 90 days. Safety outcomes included symptomatic intracranial hemorrhage and 3-month mortality. Multivariable logistic regression (adjusting for baseline systolic blood pressure, occlusion site, onset-to-puncture time, anesthesia, and first choice of EVT) and propensity score overlap weighting (balance in demographic covariates, stroke characteristics, and initial management between groups) were performed.
RESULTS
One-hundred and eighteen alteplase-treated patients in the DEVT trial and 98 tirofiban-treated patients in the RESCUE BT trial were included (median age, 70 years; 115 [53.2%] men). The rate of functional independence was 60.2% in the tirofiban group compared with 46.6% in the alteplase group (adjusted odds ratio, 1.25 [95% CI, 0.60-2.63]). Compared with alteplase, tirofiban was not associated with increased risk of symptomatic intracranial hemorrhage (6.8% versus 9.2%; =0.51) and mortality (17.8% versus 19.4%; =0.76). The propensity score overlap weighting analyses showed consistent outcomes.
CONCLUSIONS
Among patients with intracranial large vessel occlusion within 4.5 hours of onset, tirofiban plus EVT was comparable to alteplase bridging with EVT regarding the efficacy and safety outcomes. These findings should be interpreted as preliminary and require confirmation in a randomized trial.
REGISTRATION
URL: https://www.chictr.org.cn; Unique identifiers: ChiCTR-IOR-17013568 and ChiCTR-INR-17014167.
背景
本研究旨在评估急性缺血性卒中伴颅内大血管闭塞患者血管内替罗非班与阿替普酶治疗前（EVT）的疗效和安全性。
方法
这是对 2 项多中心随机试验（DEVT 试验：2018 年 5 月至 2020 年 5 月和 RESCUE BT 试验：2018 年 10 月至 2021 年 10 月）数据的事后分析。将发病 4.5 小时内的急性颅内大血管闭塞患者分为替罗非班组和阿替普酶桥接 EVT 组：替罗非班组加 EVT 与阿替普酶桥接 EVT。主要结局为 90 天时的功能独立性（改良 Rankin 量表评分为 0-2）。安全性结局包括症状性颅内出血和 3 个月死亡率。采用多变量逻辑回归（调整基线收缩压、闭塞部位、发病至穿刺时间、麻醉和 EVT 的首选方法）和倾向评分重叠加权（组间人口统计学协变量、卒中特征和初始治疗的平衡）进行分析。
结果
DEVT 试验中 118 例阿替普酶治疗患者和 RESCUE BT 试验中 98 例替罗非班治疗患者纳入分析（中位年龄 70 岁，115[53.2%]为男性）。替罗非班组的功能独立性率为 60.2%，阿替普酶组为 46.6%（调整比值比，1.25[95%CI，0.60-2.63]）。与阿替普酶相比，替罗非班不增加症状性颅内出血风险（6.8%对 9.2%；=0.51）和死亡率（17.8%对 19.4%；=0.76）。倾向评分重叠加权分析显示结果一致。
结论
在发病 4.5 小时内的颅内大血管闭塞患者中，替罗非班组加 EVT 与阿替普酶桥接 EVT 相比，疗效和安全性结局相似。这些发现应被视为初步结果，需要在随机试验中得到证实。
注册
网址：https://www.chictr.org.cn；唯一标识符：ChiCTR-IOR-17013568 和 ChiCTR-INR-17014167。
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