法国对急性缺血性前循环脑卒中且易感血管征阳性患者使用支架取出器加接触式抽吸的安全性和有效性(VECTOR):随机单盲试验。

IF 46.5 1区 医学 Q1 CLINICAL NEUROLOGY
Romain Bourcier, Gaultier Marnat, Cyril Dargazanli, François Zhu, Arturo Consoli, Eimad Shotar, Kevin Premat, François Eugene, Kevin Janot, Vincent L'Allinec, Julien Ognard, Jean-Philippe Desilles, Raphael Blanc, Jean-Christophe Gentric, Frédéric Bourdain, Julien Labreuche, Liang Liao, Frédéric Clarençon, Xavier Barreau, Héloïse Ifergan, Jean-François Hak, Basile Kerleroux, Raoul Pop, Sébastien Soize, Nicolas Bricout, Jildaz Caroff, Johann Sebastian Richter, Hubert Desal, Bertrand Lapergue, Aymeric Rouchaud
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引用次数: 0

摘要

背景:急性缺血性卒中患者的易感血管征(SVS)阳性与富含易碎红细胞的血栓有关,使用支架取栓器与接触式抽吸相比,支架取栓器能更有效地再通血栓。在急性缺血性前循环卒中和 SVS 阳性闭塞患者中,我们比较了支架取出器加接触式抽吸(联合技术)与单独接触式抽吸作为一线血栓切除技术的安全性和有效性:大颅内血管闭塞血栓磁共振成像适应性血管内治疗策略(VECTOR)是一项前瞻性、随机、开放标签研究,采用盲法评估。法国的22个中心共招募了在核磁共振成像检查中SVS阳性的前循环闭塞患者,并在症状出现后24小时内进行了动脉穿刺。介入神经放射学专家采用基于网络的集中方法,以最小化的方式进行动态随机分配。患者以 1:1 的比例被随机分配到联合技术或单独接触抽吸技术中。主要结果是治疗后血管造影通过三次或三次以下,脑梗塞溶栓(eTICI)2c级或3级再灌注,由独立的盲法中央成像核心实验室裁定。采用意向治疗人群评估主要和次要结果。该试验已在ClinicalTrials.gov(NCT04139486)上注册,并已完成:2019年11月26日至2022年2月14日期间,共有526名患者入组,其中521人构成意向治疗人群(联合技术,n=263;单独接触吸引,n=258)。参与者的中位年龄为 74-9 岁(IQR 64-4-83-3);女性 284 人(55%),男性 237 人(45%)。两组患者的主要结果差异不大(263 名患者中有 152 [58%] 采用联合技术,258 名患者中有 135 [52%] 采用接触式抽吸;几率比 [OR] 1-27;95% CI 0-88-1-83;P=0-19)。在联合技术组的 263 名患者中,有 32 人(12%)发生了与手术相关的不良事件;在接触式抽吸组的 257 名患者中,有 27 人(11%)发生了与手术相关的不良事件(OR 1-14; 0-65-2-00; p=0-65)。最常见的不良事件是脑内出血(联合技术组 259 名患者中有 146 人[56%],接触抽吸组 251 名患者中有 123 人[49%];OR 1-32;0-91-1-90;P=0-13)。联合技术组 251 名患者中有 57 人(23%)在 3 个月后全因死亡,接触式抽吸组 247 名患者中有 48 人(19%)全因死亡(OR 1-19;0-76-1-86;P=0-45),其中无一例外与治疗相关:VECTOR试验结果表明,在SVS阳性闭塞患者中,联合支架牵引器加接触式抽吸技术在三次抽吸中达到eTICI 2c-3方面并不优于单独的接触式抽吸技术。这些研究结果支持将联合技术或单独接触式抽吸技术作为急性前循环卒中患者的初始血栓切除策略,这些患者在治疗前的磁共振成像中出现 SVS:Cerenovus.
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety and efficacy of stent retrievers plus contact aspiration in patients with acute ischaemic anterior circulation stroke and positive susceptibility vessel sign in France (VECTOR): a randomised, single-blind trial.

Background: Positive susceptibility vessel sign (SVS) in patients with acute ischaemic stroke has been associated with friable red blood cell-rich clots and more effective recanalisation using stent retrievers versus contact aspiration. We compared the safety and efficacy of stent retrievers plus contact aspiration (combined technique) versus contact aspiration alone as the first-line thrombectomy technique in patients with acute ischaemic anterior circulation stroke and SVS-positive occlusions.

Methods: Adaptive Endovascular Strategy to the Clot MRI in Large Intracranial Vessel Occlusion (VECTOR) was a prospective, randomised, open-label study with blinded evaluation. Patients with SVS-positive anterior circulation occlusions on pretreatment MRI and arterial puncture within 24 h of symptom onset were enrolled from 22 centres in France. A centralised web-based method was used by interventional neuroradiologists for dynamic randomisation by minimisation. Patients were randomly assigned 1:1 to the combined technique or contact aspiration alone. The primary outcome was expanded Thrombolysis in Cerebral Infarction (eTICI) grade 2c or 3 reperfusion after three or fewer passes on post-treatment angiogram, adjudicated by a blinded independent central imaging core laboratory. The intention-to-treat population was used to assess the primary and secondary outcomes. This trial is registered with ClinicalTrials.gov (NCT04139486) and is complete.

Findings: Between Nov 26, 2019, and Feb 14, 2022, 526 patients were enrolled, of whom 521 constituted the intention-to-treat population (combined technique, n=263; contact aspiration alone, n=258). The median age of participants was 74·9 years (IQR 64·4-83·3); 284 (55%) were female and 237 (45%) male. The primary outcome did not differ significantly between groups (152 [58%] of 263 patients for the combined technique vs 135 [52%] of 258 for contact aspiration; odds ratio [OR] 1·27; 95% CI 0·88-1·83; p=0·19). Procedure-related adverse events occurred in 32 (12%) of 263 patients in the combined technique group and 27 (11%) of 257 in the contact aspiration group (OR 1·14; 0·65-2·00; p=0·65). The most common adverse event was intracerebral haemorrhage (146 [56%] of 259 patients for the combined technique vs 123 [49%] of 251 for contact aspiration; OR 1·32; 0·91-1·90; p=0·13). All-cause mortality at 3 months occurred in 57 (23%) of 251 patients in the combined technique group and 48 (19%) of 247 in the contact aspiration group (OR 1·19; 0·76-1·86; p=0·45), none of which was treatment-related.

Interpretation: The results of the VECTOR trial do not show superiority of the combined stent retriever plus contact aspiration technique over contact aspiration alone in patients with SVS-positive occlusion with respect to achieving eTICI 2c-3 within three passes. These findings support the use of either the combined technique or contact aspiration alone as the initial thrombectomy strategy in patients with acute anterior circulation stroke with SVS on pretreatment MRI.

Funding: Cerenovus.

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来源期刊
Lancet Neurology
Lancet Neurology 医学-临床神经学
CiteScore
58.70
自引率
1.00%
发文量
572
审稿时长
6-12 weeks
期刊介绍: The Lancet Neurology is the world-leading clinical neurology journal. It publishes original research that advocates for change in, or sheds light on, neurological clinical practice. The topics covered include cerebrovascular disease, Alzheimer's disease and other dementias, epilepsy, migraine, neurological infections, movement disorders, multiple sclerosis, neuromuscular disorders, peripheral nerve disorders, pediatric neurology, sleep disorders, and traumatic brain injury. The journal publishes a range of article types, including Articles (including randomized clinical trials and meta-analyses), Review, Rapid Review, Comment, Correspondence, and Personal View. It also publishes Series and Commissions that aim to shape and drive positive change in clinical practice and health policy in areas of need in neurology. The Lancet Neurology is an internationally trusted source of clinical, public health, and global health knowledge. It has an Impact Factor of 48.0, making it the top-ranked clinical neurology journal out of 212 journals worldwide.
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