Thrombectomy improved functional independence but increased hemorrhage risk in moderate-to-severe acute ischemic stroke patients

BACKGROUND: Endovascular thrombectomy for acute ischemic stroke due to medium-vessel occlusion has had varying results across trials. Whether thrombectomy improves functional outcomes in patients with medium-vessel occlusion and moderate-to-severe deficits is unclear. METHODS: We conducted an open-label, randomized trial with blinded outcome assessment at 48 centers in China. Eligible patients were adults who presented within 24 hours after the onset of a moderate-to-severe stroke (National Institutes of Health Stroke Scale [NIHSS] score, ≥6; scale, 0 to 42, with higher scores indicating greater neurologic deficits) due to occlusion of a medium vessel. Patients were assigned in a 1:1 ratio to thrombectomy plus medical management (thrombectomy group) or medical management alone (control group). The primary outcome was functional disability as measured by the shift in the modified Rankin scale score (scale, 0 [no disability] to 6 [death]) at 90 days. Violation of the proportional-odds assumption precluded the use of shift in the modified Rankin scale score, so as prespecified, functional independence (modified Rankin scale score of 0, 1, or 2) at 90 days was used as the primary outcome. Safety outcomes were symptomatic intracranial hemorrhage and 90-day mortality. RESULTS: Among 280 patients in the thrombectomy group and 283 in the control group, the median age was 71 years, the median NIHSS score was 10 (range, 3 to 36), and 42.8% were women; 36.6% received intravenous thrombolysis. Functional independence at 90 days was seen in 58.6% of the patients in the thrombectomy group and in 46.6% of those in the control group (adjusted rate ratio, 1.24; 95% confidence interval, 1.07 to 1.44; P = 0.004). The incidence of symptomatic intracranial hemorrhage was 4.7% in the thrombectomy group and 2.2% in the control group; 90-day mortality was 11.1% and 10.2%, respectively. CONCLUSIONS: Among patients with acute ischemic stroke due to medium-vessel occlusion and moderate-to-severe deficits, thrombectomy led to a greater likelihood of functional independence than medical management alone but also to a higher risk of symptomatic intracranial hemorrhage. (Funded by the National Natural Science Foundation of China and the Noncommunicable Chronic Diseases-National Science and Technology Major Project; ORIENTAL-MeVO ClinicalTrials.gov number, NCT06146790.).