Dr. Arobelidze
Clinical question: Does endovascular therapy for acute stroke with a large ischemic region have better functional outcomes compared to medical therapy alone without increasing the risk of major adverse effects?
Background: Guidelines recommend consideration of endovascular therapy when there is occlusion of the M1 segment of the middle cerebral artery (MCA) or internal carotid artery (ICA) and when imaging indicates that the size of the infarct area is not large, as defined by Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) value of a least 6 (range from 0-10 with lower values indicating greater infarct burden). Patients with large infarctions (e.g., those with an ASPECTS value of 5 or less) have been generally excluded from clinical trials of endovascular therapy or represented in small numbers. Modified Rankin scale has been used for the assessment of the value of quality of life at the level of function in stroke clinical trials with a scale from 0 to 6 with higher scores indicating greater disability.
Study design: Multicenter, open-label, randomized clinical trial
Settings: 45 hospitals in Japan from November 2018 to September 2021
Synopsis: The study enrolled 203 patients, with 101 assigned to the endovascular-therapy group and 102 to the medical-care group. The mean age of the patients was 76 years and 44.3% were women. The median National Institutes of Health Stroke Scale (NIHSS) at trial entry was 22 and the median ASPECTS value was 3 at admission. Modified Rankin score of 0-3 at 90 days was observed in 31% of patients in the endovascular group and 12.7% in the medical group (RR, 2.43; 95% CI, 1.35 to 4.37; P=0.002). In the endovascular group, 31% of patients had improvement of at least 8 points on the NIHSS at 48 hours after admission compared to 8.8% in the medical-care group (RR, 3.51; 95% CI, 1.76 to 7.00). The occurrence of any intracranial hemorrhage within 48 hours was higher in the endovascular therapy than in the medical-care group (58.0% versus 31.4%; RR, 1.85; 95% CI, 1.33 to 2.58; P <0.001), but there was no significant between-group difference in symptomatic intracranial hemorrhage within 48 hours or death at 90 days. The study limitations included a lack of generalizability beyond the Japanese population.
Bottom line: The functional outcomes in patients with acute stroke and a large ischemic region at 90 days were better with endovascular therapy than with medical care alone, but endovascular therapy was associated with an increased incidence of intracranial hemorrhage. However, there was no significant between-group difference in symptomatic intracranial hemorrhage.
Citation: Yoshimura S, et al. Endovascular therapy for acute stroke with a large ischemic region. N Engl J Med. 2022;386(14):1303-13.
Dr. Arobelidze is an associate staff physician at the Cleveland Clinic, Cleveland, and a clinical assistant professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University of Medicine.