Endovascular therapy for acute stroke with a large ischemic region
Endovascular therapy for acute ischemic stroke is generally avoided if the infarction is large, but the effect of endovascular therapy with medical care versus medical care alone in large stroke has not been well studied.
We conducted a multicenter, open-label, randomized clinical trial in Japan in patients with large cerebral vascular occlusion and significant stroke on imaging, as determined by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) score of 3 to 5 (on a scale of 0 to 10, with lower values indicating greater infarction). Patients were randomized in a 1:1 ratio to undergo endovascular therapy with medical care or medical care alone within 6 hours of being known to be last well, or within 24 hours if fluid-damped inversion recovery images did not change , allocated. Alteplase (0.6 mg per kilogram of body weight) was used as needed in both groups. The primary outcome was a score on the modified Rankin scale of 0 to 3 (on a scale of 0 to 6, with higher scores indicating greater disability) at 90 days. Secondary endpoints included a shift across the range of modified Rankin scores toward a better outcome at 90 days and an improvement of at least 8 points in the National Institutes of Health Stroke Scale (NIHSS) score (range 0 to 42, with higher score). indicating a greater deficit) after 48 hours.
A total of 203 patients were randomized; 101 patients were assigned to the endovascular therapy group and 102 to the medical care group. Approximately 27% of patients in each group received alteplase. The percentage of patients with a modified Rankin score of 0 to 3 at 90 days was 31.0% in the endovascular therapy group and 12.7% in the medical care group (relative risk 2.43; 95% confidence interval [CI], 1.35 to 4.37; P=0.002). The ordinal shift across the range of modified Rankin scale scores generally favored endovascular therapy. An improvement in NIHSS score of at least 8 points at 48 hours was observed in 31.0% of patients in the endovascular therapy group and 8.8% of patients in the medical care group (relative risk 3.51; 95 % CI 1.76). to 7.00) and intracranial hemorrhage occurred in 58.0% and 31.4%, respectively (P
In a study conducted in Japan, patients with large cerebral infarctions had better functional outcomes with endovascular therapy than with medical care alone, but had more intracranial hemorrhage. (Funded by the Mihara Cerebrovascular Disorder Research Promotion Fund and the Japanese Society for Neuroendovascular Therapy; RESCUE-Japan LIMIT ClinicalTrials.gov number, NCT03702413.)