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Randomized Controlled Trial
. 2024 Jul;55(7):1730-1738.
doi: 10.1161/STROKEAHA.124.046828. Epub 2024 May 28.

Expanding the Treatable Imaging Profile in Patients With Large Ischemic Stroke: Subanalysis From a Randomized Clinical Trial

Manabu Inoue  1   2 , Takeshi Yoshimoto  3 , Hiroshi Yamagami  4 , Kazunori Toyoda  2 , Nobuyuki Sakai  5 , Yuji Matsumaru  6 , Yasushi Matsumoto  7 , Kazumi Kimura  8 , Reiichi Ishikura  9 , Kazutaka Uchida  10   11 , Mikiya Beppu  10 , Fumihiro Sakakibara  10   11 , Takeshi Morimoto  11 , Shinichi Yoshimura  10 ; RESCUE-Japan LIMIT Investigators
Affiliations
Randomized Controlled Trial

Expanding the Treatable Imaging Profile in Patients With Large Ischemic Stroke: Subanalysis From a Randomized Clinical Trial

Manabu Inoue et al. Stroke. 2024 Jul.

Abstract

Background: We aimed to examine the boundary of the ischemic core volume in patients undergoing endovascular thrombectomy (EVT) versus those receiving medical management to determine the minimum optimal size for favorable treatment outcomes.

Methods: This is a prespecified substudy of the RESCUE-Japan LIMIT (Recovery by Endovascular Salvage for Cerebral Ultra-Acute Embolism-Japan Large Ischemic Core Trial). Patients with large vessel occlusion were enrolled between November 2018 and September 2021 with a National Institutes of Health Stroke Scale score of at least 6 on admission and an Alberta Stroke Program Early Computed Tomography Score value of 3 to 5. We investigated the correlation between optimal quantified ischemic core volume, assessed solely using magnetic resonance diffusion-weighted imaging, and functional outcomes (modified Rankin Scale score, 0-3) at 90 days by predictive marginal plots. Final infarct volume and safety outcomes (symptomatic intracerebral hemorrhage and mortality) were also assessed.

Results: Of the 203 cases, 168 patients (85 in the EVT group versus 83 in the medical management group) were included. The median (interquartile range) core volume was 94 (65-160) mL in patients with EVT and 115 (71-141) mL in the medical management group (P=0.72). The predictive marginal probabilities of the 2 groups intersected at 128 mL for estimating functional outcomes. Symptomatic intracerebral hemorrhage and mortality within 90 days had overlay margins through all core volumes in both groups. The median final infarct volume (interquartile range) was smaller in the EVT group (142 [80-223] mL versus 211 [123-289] mL in the medical management group; P<0.001).

Conclusions: In this prespecified analysis of a randomized clinical trial involving patients with large ischemic strokes, patients with an estimated core volume of up to 128 mL on diffusion-weighted imaging benefit from EVT.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03702413.

Keywords: diffusion magnetic resonance imaging; ischemic stroke; magnetic resonance imaging; thrombectomy.

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Conflict of interest statement

Disclosures Dr Inoue reports the lecturer’s fees from Bayer, Bristol-Myers Squibb, and Nippon Boehringer Ingelheim. Dr Yoshimoto reports lecture fees from Takeda Pharmaceutical and Nippon Boehringer Ingelheim. Dr Toyoda reports lecture fees from Bayer, Daiichi Sankyo, Takeda, and Bristol-Myers Squibb. Dr Yamagami discloses research grants from Bristol-Myers Squibb; lecturer’s fees from Stryker, Medtronic, Terumo, Johnson & Johnson, Biomedical Solutions, and Medico’s Hirata; and membership of the advisory boards for Daiichi Sankyo. Dr Sakai reports research grants from Biomedical Solutions, Daiichi Sankyo, and Terumo; 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 Matsumaru reports lecturer fees from Medtronic, Stryker, Terumo, Johnson & Johnson, Kaneka, and Jimro. Dr Matsumoto reports the lecturer’s fees from Kaneka, Medico’s Hirata, Fuji systems, GE Healthcare, Otsuka, Takeda, Century Medical, Terumo, Medtronic, and Stryker. Dr Kimura reports research grants from CSL Behring, Eisai, Kyowa Kirin, Daiichi Sankyo, Teijin, Medtronic, Bristol-Myers Squibb, Bayer, Boehringer Ingelheim, Helios; and lecturer’s fees from Daiichi Sankyo, Boehringer Ingelheim, Bristol-Myers Squibb, Bayer, Takeda, Medtronic, Otsuka, FP, Alexion, Sanofi, CSL Behring, Novartis, Toa Eiyo, Medico’s Hirata, and Helios. Dr Uchida reports lecturer’s fees from Daiichi Sankyo, Bristol-Myers Squibb, Stryker, and Medtronic. Dr Beppu reports manuscript fees from Medicus Shuppan. Dr Sakakibara reports manuscript fees from Medicus Shuppan. Dr Morimoto reports lecturer’s fees from AstraZeneca, Bristol-Myers Squibb, Daiichi Sankyo, Japan Lifeline, Kowa, Pfizer, and Tsumura; manuscript fees from Bristol-Myers Squibb and Pfizer; advisory board for Novartis and Teijin. Dr Yoshimura reports research grants from Medico’s Hirata, Medtronic, and Terumo; and lecturer fees from Medtronic, Kaneka, Stryker, Daiichi Sankyo, Bristol-Meyers Squibb, and Johnson & Johnson. The other author reports no conflicts.

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