作者
Kazutaka Uchida,Seigo Shindo,Shinichi Yoshimura,Ḱazunori Toyoda,Nobuyuki Sakai,Hiroshi Yamagami,Yuji Matsumaru,Yasushi Matsumoto,Kazumi Kimura,Reiichi Ishikura,Astushi Yoshida,Manabu Inoue,M. Beppu,Fumihiro Sakakibara,Manabu Shirakawa,Takeshi Morimoto,Naoya Kuwayama,Kuniaki Ogasawara,Teruyuki Hirano,Norito Kinjo,Takuya Saito,Masataka Takeuchi,Yukako Yazawa,Naoto Kimura,Keigo Shigeta,Hirotoshi Imamura,Ichirō Suzuki,Yukiko Enomoto,So Tokunaga,Kenichi Morita,Kanta Tanaka,Ryuzaburo Kanazawa,Takumi Asai,Norihito Shimamura,Hideyuki Ishihara,Masafumi Morimoto,Hiroyuki Ohnishi,Yoshinori Akiyama,Nobuhisa Matsushita,Nobuaki Yamamoto,Koichi Haraguchi,Hayato Araki,Atsushi Ogata,Hirotaka Okumura,Tatsuya Ogino,Yoshitaka Yamada,Takahiro Ota,Yoshifumi Tsuboi,Takehiro Yamada,Manabu Nagata,Kenichi Todo,Fuminori Shimizu,Yasushi Ueno,Masataka Yoshimura,Wataro Tsuruta,Yoichi Morofuji,Naoki Toma,Tomoya Omae,Makoto Sakamoto,Toshihiro Ueda,Shinya Koyama
摘要
Endovascular therapy (EVT) has been found to reduce functional disability in patients with acute stroke due to large-vessel occlusion. However, the extent of the ischemic region, measured using Alberta Stroke Program Early Computed Tomography Scores, may limit the efficacy of EVT.To compare the efficacy and safety of EVT according to ASPECTS 3 or less vs 4 to 5.The Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism-Japan Large Ischemic Core Trial (RESCUE-Japan LIMIT) was an open-label randomized clinical trial conducted from November 2018 to December 2021 at 45 stroke centers across Japan. The trial enrolled adult patients with acute ischemic stroke with a large ischemic region, defined as ASPECTS 3 to 5 primarily determined by magnetic resonance imaging, with occlusion site at the internal carotid artery or middle cerebral artery segment 1. Among 203 enrolled patients, 1 withdrew consent and 202 were included in the original trial and secondary analysis. This secondary analysis was conducted in April 2022.Patients were randomly assigned to EVT with medical therapy or medical therapy alone.Modified Rankin Scale (mRS) score at 90 days and symptomatic and any intracranial hemorrhage within 48 hours.Among 202 patients, 106 (52%) had ASPECTS 3 or less (mean [SD] age, 76.7 [9.6] years; 54 female individuals [50.9%]) and 96 had ASPECTS 4 to 5 (mean [SD] age, 75.6 [10.6] years; 36 female individuals [37.5%]). Of patients with ASPECTS 3 or less, 12 (21.4%) in the EVT group and 9 (18.0%) in the no EVT group had an mRS score of 0 to 3 (odds ratio [OR], 1.24; 95% CI, 0.47-3.26). Of patients with ASPECTS 4 to 5, 19 patients (43.2%) in the EVT group and 4 (7.7%) in the no EVT group had an mRS score of 0 to 3 at 90 days (OR, 9.12; 95% CI, 2.80-29.70; interaction P = .01). The ordinal shift across the range of mRS scores toward a better outcome was not significant in those with ASPECTS or 3 or less (common OR, 1.56; 95% CI, 0.79-3.10) but was significant in those with ASPECTS 4 to 5 (common OR, 4.48; 95% CI, 2.07-9.71; interaction P = .046). The risk of intracranial hemorrhage was significantly increased in patients with ASPECTS 3 or less when EVT was conducted (OR, 4.14; 95% CI, 1.84-9.32) and nonsignificantly increased in those with ASPECTS 4 to 5 (OR, 2.05; 95% CI, 0.89-4.73; interaction P = .24).In this study, EVT was associated with improved 90-day functional outcomes in patients with acute large vessel occlusive stroke and ASPECTS was 4 to 5 but not in those with ASPECTS 3 or less.ClinicalTrials.gov Identifier: NCT03702413.