Endovascular treatment to improve outcomes for medium vessel occlusions: The ESCAPE-MeVO trial.

IF 6.3 2区 医学 Q1 CLINICAL NEUROLOGY International Journal of Stroke Pub Date : 2024-10-01 Epub Date: 2024-06-20 DOI:10.1177/17474930241262642
Johanna M Ospel, Dar Dowlatshahi, Andrew Demchuk, David Volders, Markus Möhlenbruch, Shahid Nimjee, James Kennedy, Brian Buck, Jai Jai Shankar, Thomas C Booth, Mouhammad A Jumaa, Robert Fahed, Aravind Ganesh, Qiao Zhang, Craig Doram, Karla J Ryckborst, Michael D Hill, Mayank Goyal
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Abstract

Rationale: Clinical outcomes in acute ischemic stroke due to medium vessel occlusion (MeVO) are often poor when treated with best medical management. Data from non-randomized studies suggest that endovascular treatment (EVT) may improve outcomes in MeVO stroke, but randomized data on potential benefits and risks are hitherto lacking. Thus, there is insufficient evidence to guide EVT decision-making in MeVO stroke.

Aims: The primary aim of the ESCAPE-MeVO trial is to demonstrate that acute, rapid EVT in patients with acute ischemic stroke due to MeVO results in better clinical outcomes compared to best medical management. Secondary outcomes are to demonstrate the safety of EVT, its impact on self-reported health-related quality of life, and cost-effectiveness.

Sample size estimates: Based on previously published data, we estimate a sample size of 500 subjects to achieve a power of 85% with a two-sided alpha of 0.05. To account for potential loss to follow-up, 530 subjects will be recruited.

Methods and design: ESCAPE-MeVO is a multicenter, prospective, randomized, open-label study with blinded endpoint evaluation (PROBE design), clinicaltrials.gov: NCT05151172. Subjects with acute ischemic stroke due to MeVO meeting the trial eligibility criteria will be allocated in a 1:1 ratio to best medical care plus EVT versus best medical care only. Patients will be screened only at comprehensive stroke centers to determine if they are eligible for the trial, regardless of whether they were previously treated at a primary care center. Key eligibility criteria are (1) acute ischemic stroke due to MeVO that is clinically and technically eligible for EVT, (2) last-known well within the last 12 h, (3) National Institutes of Health Stroke Scale > 5 or 3-5 with disabling deficit, (4) high likelihood of salvageable tissue on non-invasive neuroimaging.

Study outcomes: The primary outcome is the modified Rankin scale 90 days after randomization (shift analysis), whereby modified Rankin Score 5 and 6 will be collapsed into one category. Secondary outcomes include dichotomizations of the modified Rankin Score at 90 days, 24 h National Institutes of Health Stroke Score, difference between 24 h and baseline National Institutes of Health Stroke Score, mortality at 90 days, health-related quality of life (EQ-5D-5 L), Lawton scale of instrumental activities of daily living score, reperfusion quality (MeVO expanded Thrombolysis in Cerebral Infarction Score) and infarct volume at 24 h, and cost-effectiveness of endovascular recanalization. Safety outcomes include symptomatic and asymptomatic intracranial hemorrhage and procedural complications.

Discussion: The ESCAPE-MeVO trial will demonstrate the effect of endovascular thrombectomy in addition to best medical management vis-à-vis best medical management in patients with acute ischemic stroke due to MeVO and provide data for evidence-based treatment decision-making in acute MeVO stroke.

Data access statement: The raw data discussed in this mansucript will be made available by the corresponding author upon reasonable request.

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改善中血管闭塞预后的血管内治疗:ESCAPE-MeVO试验。
理由:中血管闭塞(MeVO)导致的急性缺血性卒中在接受最佳药物治疗后,临床疗效往往不佳。非随机研究数据表明,血管内治疗(EVT)可改善中血管闭塞性卒中的预后,但迄今为止尚缺乏有关潜在益处和风险的随机数据。目的:ESCAPE-MeVO 试验的主要目的是证明对 MeVO 引起的急性缺血性卒中患者进行急性、快速 EVT 与最佳内科治疗相比可获得更好的临床疗效。次要结果是证明 EVT 的安全性、对自我报告的健康相关生活质量的影响以及成本效益:根据之前公布的数据,我们估计样本量为 500 名受试者,双侧α值为 0.05 时的功率为 85%。考虑到可能的随访损失,我们将招募 530 名受试者:ESCAPE-MeVO是一项多中心、前瞻性、随机、开放标签研究,采用盲法终点评估(PROBE设计),clinicaltrials.gov:NCT05151172。符合试验资格标准的 MeVO 急性缺血性脑卒中受试者将按 1:1 的比例分配到最佳医疗加 EVT 与仅最佳医疗中。患者将只在综合卒中中心接受筛查,以确定其是否符合试验条件,无论其之前是否在初级医疗中心接受过治疗。主要资格标准为:1)因MeVO导致的急性缺血性卒中,临床和技术上均符合EVT治疗条件;2)在过去12小时内最后一次获知病情;3)美国国立卫生研究院卒中量表>5或3-5,伴有致残性缺损;4)在非侵入性神经影像学检查中发现可挽救组织的可能性很高:主要结果是随机分组 90 天后的改良 Rankin 评分(移位分析),其中改良 Rankin 评分 5 分和 6 分将合并为一类。次要结果包括:90天时的改良Rankin评分的二分法、24小时美国国立卫生研究院卒中评分、24小时美国国立卫生研究院卒中评分与基线美国国立卫生研究院卒中评分之间的差异、90天时的死亡率、健康相关生活质量(EQ-5D-5L)、Lawton日常生活工具活动评分、24小时时的再灌注质量(MeVO扩大脑梗塞溶栓评分)和梗塞体积,以及血管内再通的成本效益。安全性结果包括无症状和无症状颅内出血以及手术并发症:ESCAPE-MeVO试验将证明在最佳内科治疗的基础上进行血管内血栓切除术与最佳内科治疗相比,对MeVO引起的急性缺血性卒中患者的效果,并为急性MeVO卒中的循证治疗决策提供数据。
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来源期刊
International Journal of Stroke
International Journal of Stroke 医学-外周血管病
CiteScore
13.90
自引率
6.00%
发文量
132
审稿时长
6-12 weeks
期刊介绍: The International Journal of Stroke is a welcome addition to the international stroke journal landscape in that it concentrates on the clinical aspects of stroke with basic science contributions in areas of clinical interest. Reviews of current topics are broadly based to encompass not only recent advances of global interest but also those which may be more important in certain regions and the journal regularly features items of news interest from all parts of the world. To facilitate the international nature of the journal, our Associate Editors from Europe, Asia, North America and South America coordinate segments of the journal.
期刊最新文献
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