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血管内接触抽吸与支架取栓术对急性缺血性卒中合并大血管闭塞患者血管再通的影响:ASTER随机临床试验

Effect of Endovascular Contact Aspiration vs Stent Retriever on Revascularization in Patients With Acute Ischemic Stroke and Large Vessel Occlusion: The ASTER Randomized Clinical Trial.

作者信息

Lapergue Bertrand, Blanc Raphael, Gory Benjamin, Labreuche Julien, Duhamel Alain, Marnat Gautier, Saleme Suzana, Costalat Vincent, Bracard Serge, Desal Hubert, Mazighi Mikael, Consoli Arturo, Piotin Michel

机构信息

Department of Stroke Center and Diagnostic and Interventional Neuroradiology, University of Versailles and Saint Quentin en Yvelines, Foch Hospital, Suresnes, France.

Department of Diagnostic and Interventional Neuroradiology, Rothschild Foundation, Paris, France.

出版信息

JAMA. 2017 Aug 1;318(5):443-452. doi: 10.1001/jama.2017.9644.

Abstract

IMPORTANCE

The benefits of endovascular revascularization using the contact aspiration technique vs the stent retriever technique in patients with acute ischemic stroke remain uncertain because of lack of evidence from randomized trials.

OBJECTIVE

To compare efficacy and adverse events using the contact aspiration technique vs the standard stent retriever technique as a first-line endovascular treatment for successful revascularization among patients with acute ischemic stroke and large vessel occlusion.

DESIGN, SETTING, AND PARTICIPANTS: The Contact Aspiration vs Stent Retriever for Successful Revascularization (ASTER) study was a randomized, open-label, blinded end-point clinical trial conducted in 8 comprehensive stroke centers in France (October 2015-October 2016). Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation within 6 hours of symptom onset were included.

INTERVENTIONS

Patients were randomly assigned to first-line contact aspiration (n = 192) or first-line stent retriever (n = 189) immediately prior to mechanical thrombectomy.

MAIN OUTCOMES AND MEASURES

The primary outcome was the proportion of patients with successful revascularization defined as a modified Thrombolysis in Cerebral Infarction score of 2b or 3 at the end of all endovascular procedures. Secondary outcomes included degree of disability assessed by overall distribution of the modified Rankin Scale (mRS) score at 90 days, change in National Institutes of Health Stroke Scale (NIHSS) score at 24 hours, all-cause mortality at 90 days, and procedure-related serious adverse events.

RESULTS

Among 381 patients randomized (mean age, 69.9 years; 174 women [45.7%]), 363 (95.3%) completed the trial. Median time from symptom onset to arterial puncture was 227 minutes (interquartile range, 180-280 minutes). For the primary outcome, the proportion of patients with successful revascularization was 85.4% (n = 164) in the contact aspiration group vs 83.1% (n = 157) in the stent retriever group (odds ratio, 1.20 [95% CI, 0.68-2.10]; P = .53; difference, 2.4% [95% CI, -5.4% to 9.7%]). For the clinical efficacy outcomes (change in NIHSS score at 24 hours, mRS score at 90 days) and adverse events, there were no significant differences between groups.

CONCLUSIONS AND RELEVANCE

Among patients with ischemic stroke in the anterior circulation undergoing thrombectomy, first-line thrombectomy with contact aspiration compared with stent retriever did not result in an increased successful revascularization rate at the end of the procedure.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT02523261.

摘要

重要性

由于缺乏随机试验的证据,对于急性缺血性中风患者,使用接触抽吸技术与支架取栓技术进行血管内血运重建的益处仍不确定。

目的

比较使用接触抽吸技术与标准支架取栓技术作为急性缺血性中风和大血管闭塞患者成功血运重建的一线血管内治疗的疗效和不良事件。

设计、地点和参与者:接触抽吸与支架取栓成功血运重建(ASTER)研究是一项在法国8个综合卒中中心进行的随机、开放标签、终点盲法临床试验(2015年10月至2016年10月)。纳入症状发作6小时内出现急性缺血性中风且前循环大血管闭塞的患者。

干预措施

在机械取栓前,患者被随机分配至一线接触抽吸组(n = 192)或一线支架取栓组(n = 189)。

主要结局和测量指标

主要结局是在所有血管内操作结束时,成功血运重建的患者比例,定义为改良脑梗死溶栓评分2b或3分。次要结局包括90天时通过改良Rankin量表(mRS)评分的总体分布评估的残疾程度、24小时时美国国立卫生研究院卒中量表(NIHSS)评分的变化、90天时的全因死亡率以及与手术相关的严重不良事件。

结果

在381例随机分组的患者中(平均年龄69.9岁;174例女性[45.7%]),363例(95.3%)完成试验。从症状发作到动脉穿刺的中位时间为227分钟(四分位间距,180 - 280分钟)。对于主要结局,接触抽吸组成功血运重建的患者比例为85.4%(n = 164),支架取栓组为83.1%(n = 157)(优势比,1.20[95%CI,0.68 - 2.10];P = 0.53;差异,2.4%[95%CI,-5.4%至9.7%])。对于临床疗效结局(24小时时NIHSS评分的变化、90天时mRS评分)和不良事件,两组之间无显著差异。

结论及相关性

在前循环缺血性中风接受取栓治疗的患者中,与支架取栓相比,一线采用接触抽吸取栓在手术结束时并未提高成功血运重建率。

试验注册

clinicaltrials.gov标识符:NCT02523261。

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