Endovascular Therapy for Acute Stroke with a Large Ischemic Region

医学 改良兰金量表 随机对照试验 随机化 冲程(发动机) 血管内治疗 缺血性中风 溶栓 心肌梗塞 脑梗塞 内科学 心脏病学 物理疗法 急诊医学 急性中风 外科
作者
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,T. Morimoto
出处
期刊:The New England Journal of Medicine [Massachusetts Medical Society]
卷期号:386 (14): 1303-1313 被引量:18
标识
DOI:10.1056/nejmoa2118191
摘要

Endovascular 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.We 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.A 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).In 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.).
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