• Shinichi Yoshimura, Nobuyuki Sakai, Hiroshi Yamagami, Kazutaka Uchida, Mikiya Beppu, Kazunori Toyoda, Yuji Matsumaru, Yasushi Matsumoto, Kazumi Kimura, Masataka Takeuchi, Yukako Yazawa, Naoto Kimura, Keigo Shigeta, Hirotoshi Imamura, Ichiro Suzuki, Yukiko Enomoto, So Tokunaga, Kenichi Morita, Fumihiro Sakakibara, Norito Kinjo, Takuya Saito, Reiichi Ishikura, Manabu Inoue, and Takeshi Morimoto.
• From the Departments of Neurosurgery (S.Y., K.U., M.B., F.S., N. Kinjo) and Clinical Epidemiology (K.U., F.S., N. Kinjo, T.S., T.M.), Hyogo College of Medicine, Nishinomiya, the Departments of Neurosurgery (N.S., H.I.) and Diagnostic Radiology (R.I.), Kobe City Medical Center General Hospital, Kobe, the Department of Stroke Neurology, National Hospital Organization Osaka National Hospital, Osaka (H.Y.), the Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita (K.T., M.I.), the Division of Stroke Prevention and Treatment, Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Ibaraki (Y. Matsumaru), the Department of Neuroendovascular Therapy (Y. Matsumoto) and the Department of Stroke Neurology (Y.Y., T.S.), Kohnan Hospital, Sendai, the Department of Neurology, Graduate School of Medicine, Nippon Medical School, Tokyo (K.K.), the Department of Neurosurgery, Seisho Hospital, Odawara (M.T.), the Department of Neurosurgery, Iwate Prefectural Central Hospital, Morioka (N. Kimura), the Department of Neurosurgery, National Hospital Organization Disaster Medical Center, Tachikawa (K.S.), the Department of Neuroendovascular Therapy, Hachinohe City Hospital, Hachinohe (I.S.), the Department of Neurosurgery, Gifu University Hospital, Gifu (Y.E.), the Department of Neuroendovascular Therapy, National Hospital Organization Kyusyu Medical Center, Fukuoka (S.T.), and the Department of Cerebrovascular Medicine, Niigata City General Hospital, Niigata (K.M.) - all in Japan.
• N. Engl. J. Med. 2022 Apr 7; 386 (14): 1303-1313.

BackgroundEndovascular therapy for acute ischemic stroke is generally avoided when the infarction is large, but the effect of endovascular therapy with medical care as compared with medical care alone for large strokes has not been well studied.MethodsWe conducted a multicenter, open-label, randomized clinical trial in Japan involving patients with occlusion of large cerebral vessels and sizable strokes on imaging, as indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) value of 3 to 5 (on a scale from 0 to 10, with lower values indicating larger infarction). Patients were randomly assigned in a 1:1 ratio to receive endovascular therapy with medical care or medical care alone within 6 hours after they were last known to be well or within 24 hours if there was no early change on fluid-attenuated inversion recovery images. Alteplase (0.6 mg per kilogram of body weight) was used when appropriate in both groups. The primary outcome was a modified Rankin scale score of 0 to 3 (on a scale from 0 to 6, with higher scores indicating greater disability) at 90 days. Secondary outcomes included a shift across the range of modified Rankin scale 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 scores indicating greater deficit) at 48 hours.ResultsA total of 203 patients underwent randomization; 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 scale 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 of at least 8 points on the NIHSS score at 48 hours was observed in 31.0% of the patients in the endovascular-therapy group and 8.8% of those in the medical-care group (relative risk, 3.51; 95% CI, 1.76 to 7.00), and any intracranial hemorrhage occurred in 58.0% and 31.4%, respectively (P<0.001).ConclusionsIn a trial conducted in Japan, patients with large cerebral infarctions had better functional outcomes with endovascular therapy than with medical care alone but had more intracranial hemorrhages. (Funded by Mihara Cerebrovascular Disorder Research Promotion Fund and the Japanese Society for Neuroendovascular Therapy; RESCUE-Japan LIMIT ClinicalTrials.gov number, NCT03702413.).Copyright © 2022 Massachusetts Medical Society.

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