Trial of Endovascular Therapy for Mild Stroke with Large-Vessel Occlusion

Whether endovascular therapy benefits patients with mild acute ischemic stroke from large-vessel occlusion involving the anterior circulation is uncertain.

We conducted a multicenter, open-label, randomized trial in China involving patients with acute ischemic stroke of mild clinical severity (defined by a score of <6 on the National Institutes of Health Stroke Scale) that had resulted from large-vessel occlusion involving the anterior circulation. Patients also had neuroimaging features of a small infarct core and a large perfusion-mismatch volume, representing substantial at-risk tissue, within 24 hours after symptom onset or after they were last known to be well. The patients were randomly assigned to undergo endovascular therapy and receive medical management or to receive medical management alone. The primary outcome was an excellent functional outcome (defined by a modified Rankin scale score of 0 [no symptoms] or 1 [no clinically significant disability]) at 90 days.

A total of 304 patients underwent randomization, of whom 300 were included in the modified intention-to-treat population: 144 in the endovascular-therapy group and 156 in the medical-management group. At 90 days, a modified Rankin scale score of 0 or 1 was reported in 69.4% of the patients in the endovascular-therapy group and in 50.0% of those in the medical-management group (odds ratio, 2.32; 95% confidence interval, 1.41 to 3.81; P<0.001). Symptomatic intracranial hemorrhage within 48 hours occurred in 3 patients in each group. Serious procedure-related complications occurred in 19 patients (13.2%) in the endovascular-therapy group. Among all the participants, one death occurred (in the endovascular-therapy group).

In this trial from China involving patients with mild acute ischemic stroke caused by large-vessel occlusion and substantial at-risk tissue on perfusion imaging, endovascular therapy performed within 24 hours after symptom onset plus medical management resulted in better 90-day functional outcomes than medical management alone, without an increase in the risk of symptomatic intracranial hemorrhage but with a high incidence of serious procedural complications. (Funded by Fujian Medical University Union Hospital and others; MILD-MT ClinicalTrials.gov number, NCT06179017.).