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

Background Whether endovascular therapy benefits patients with mild acute ischemic stroke from large-vessel occlusion involving the anterior circulation is uncertain. Methods 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 were randomly assigned, in a 1:1 ratio, to receive endovascular therapy plus medical management or 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. Results 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). Conclusions 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.)