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. 2022 Mar 15;62(3):156-164.
doi: 10.2176/nmc.rc.2021-0311. Epub 2021 Dec 24.

Randomized Clinical Trial of Endovascular Therapy for Acute Large Vessel Occlusion with Large Ischemic Core (RESCUE-Japan LIMIT): Rationale and Study Protocol

Shinichi Yoshimura  1 , Kazutaka Uchida  1   2 , Nobuyuki Sakai  3 , Hiroshi Yamagami  4 , Manabu Inoue  5 , Kazunori Toyoda  5 , Yuji Matsumaru  6 , Yasushi Matsumoto  7 , Kazumi Kimura  8 , Reiichi Ishikura  9 , Takeshi Morimoto  2
Affiliations

Randomized Clinical Trial of Endovascular Therapy for Acute Large Vessel Occlusion with Large Ischemic Core (RESCUE-Japan LIMIT): Rationale and Study Protocol

Shinichi Yoshimura et al. Neurol Med Chir (Tokyo). .

Abstract

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.

Keywords: acute ischemic stroke; endovascular therapy; large ischemic core; large vessel occlusion; randomized clinical trial.

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Conflict of interest statement

Conflicts of Interest Disclosure

Dr. Yoshimura reports research grants from Medico’s Hirata, Medtronic, and Termo, and lecturer fees from Medtronic, Kaneka, and Stryker. Dr. Uchida reports lecturer’s fees from Daiichi-Sankyo, Bristol-Myers Squibb, Stryker, and Medtronic. Dr. Sakai reports a research grant from Biomedical Solutions, Daiichi-Sankyo, and Termo; lecturer’s fees from Asahi-Intec, Biomedical Solutions, Daiichi-Sankyo, and Medtronic; and membership on the advisory boards for Johnson & Johnson, Medtronic, and Terumo. Dr. Yamagami discloses research grants from Bristol-Myers Squibb; lecturer’s fees from Stryker, Medtronic, Termo, Johnson & Johnson, Biomedical Solutions, and Medico’s Hirata; and membership of the advisory boards for Daiichi-Sankyo. Dr. Inoue reports the lecturer’s fees from Bayer Co., Ltd., Bristol-Myers Squibb Co., Ltd., Medico’s Hirata Co., Ltd.; and manuscript fees from Gakken Medical Co., Ltd. and Hokuryukan Co., Ltd. Dr. Toyoda reports the lecturer’s fees from Daiichi Sankyo, Takeda, Bayer Yakuhin, and Bristol-Myers Squibb. Dr. Matsumaru discloses lecturer fees from Medtronic, Stryker, Terumo, Johnson & Johnson, Kaneka, and Jimro. Dr. Mastumoto reports the lecturer’s fees from Kaneka Medics, Medico’s Hirata, Fuji systems, GE healthcare, Otuka Pharmaceutical Limited, Takeda Pharmaceutical Limited, Medtronic Japan, Century Medical, Terumo, Medtronic, and Stryker Japan. Dr. Kimura discloses research grants from CSL Behring K.K., EP-CRSU Co., Ltd., AABP K.K., Alexion Pharmaceuticals, Inc., Eisai Co., Ltd., Kyowa Kirin Co., Ltd., Daiichi-Sankyo Company, Ltd., Teijin Pharma Ltd., Medtronic Japan Co., Ltd., Bristol-Myers Squibb K.K., Bayer Yakuhin, Ltd., Boehringer-Ingelheim, and Helios Co., Ltd., and lecturer’s fees from Daiichi-Sankyo Company, Ltd., Nippon Boehringer Ingelheim Co., Ltd., Bristol-Myers Squibb K.K., Bayer Yakuhin, Ltd., Takeda Pharmaceutical Co., Ltd., Medtronic Japan Co., Ltd., Otsuka Pharmaceutical Co., Ltd., FP Pharmaceutical Co., Ltd., Alexion Pharmaceuticals, Inc., Nippon Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Abbott Medical Japan LLC, Shire PLC, Sanofi Genzyme K.K., CSL Behring K.K., Novartis Pharma K.K., Toa Eiyo Ltd., Medico’s Hirata Inc., and Helios Co., Ltd. Dr. Morimoto reports lecturers’ fees from Bristol-Myers Squibb, Daiichi Sankyo, Japan Lifeline, Kowa, Kyocera, Novartis, and Toray; manuscript fees from Bristol-Myers Squibb and Kowa; and advisory board for Sanofi. Dr. Ishikura has no conflicts of interest to report.

Figures

Fig. 1
Fig. 1
Study design. After the eligible patients arrived at each institute and informed consent was obtained, they were randomly allocated to the endovascular therapy group who received thrombectomy or to the medical therapy group without endovascular therapy. FLAIR negative: without hyperintensity on fluid-attenuated inversion recovery, MRI: magnetic resonance imaging, mRS: modified Rankin scale.
See this image and copyright information in PMC

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