Abstract Body: 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 are hitherto lacking. Thus, there is insufficient evidence to guide endovascular treatment decision-making in MeVO stroke.
Aim: 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, a sample size of 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 to best medical care plus EVT vs. best medical care only. 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 hours, 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-hour National Institutes of Health Stroke Score, difference between 24-hour and baseline National Institutes of Health Stroke Score, mortality at 90 days, self-reported health status, Lawton scale of instrumental activities of daily living score, reperfusion quality (MeVO expanded Thrombolysis in Cerebral Infarction Score) and infarct volume at 24 hours, and cost-effectiveness of endovascular recanalization. Safety outcomes include symptomatic and asymptomatic intracranial hemorrhage and procedural complications.
Results: Will be presented.