著者

Shinichi YOSHIMURA Kazutaka UCHIDA Nobuyuki SAKAI Hiroshi YAMAGAMI Manabu INOUE Kazunori TOYODA Yuji MATSUMARU Yasushi MATSUMOTO Kazumi KIMURA Reiichi ISHIKURA Takeshi MORIMOTO

出版者

The Japan Neurosurgical Society

雑誌

Neurologia medico-chirurgica (ISSN:04708105)

巻号頁・発行日

pp.rc.2021-0311, (Released:2021-12-24)

参考文献数

19

被引用文献数

13

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Endovascular therapy is strongly recommended for acute cerebral large vessel occlusion (LVO) with an Alberta stroke program early computed tomography score (ASPECTS) ≥6 due to occlusion of the internal carotid artery or M1 segment of the middle cerebral artery. However, the effect of endovascular therapy for patients with a large ischemic core with an ASPECTS ≤5 (0–5) was not established. A multicenter, randomized, open-label, parallel-group trial was conducted to investigate the superiority of endovascular therapy over medical therapy without endovascular therapy for a large ischemic core with ASPECTS (3–5). Patients were randomly assigned to receive endovascular therapy or without endovascular therapy at a ratio of 1:1. The primary outcome was a moderate functional outcome, defined as a modified Rankin scale (mRS; scores ranging from 0 [no symptoms] to 6 [death]) ≤3 after 90 days. The secondary outcomes were defined as ordinal mRS, good functional outcome (mRS ≤2), excellent functional outcome (mRS ≤1), mRS shift analysis after 90 days, and early improvement of neurological findings at 48 hours. A total sample size of 200 was estimated to provide a power of 0.9 with a two-sided alpha of 0.05, for the primary outcome, considering a 15% dropout rate. This randomized clinical trial reported the applicability of endovascular therapy in patients with acute cerebral LVO with a large ischemic core.