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Randomized Controlled Trial
. 2022 Dec 1;79(12):1260-1266.
doi: 10.1001/jamaneurol.2022.3285.

Association Between Alberta Stroke Program Early Computed Tomography Score and Efficacy and Safety Outcomes With Endovascular Therapy in Patients With Stroke From Large-Vessel Occlusion: A Secondary Analysis of the Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism-Japan Large Ischemic Core Trial (RESCUE-Japan LIMIT)

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

Association Between Alberta Stroke Program Early Computed Tomography Score and Efficacy and Safety Outcomes With Endovascular Therapy in Patients With Stroke From Large-Vessel Occlusion: A Secondary Analysis of the Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism-Japan Large Ischemic Core Trial (RESCUE-Japan LIMIT)

Kazutaka Uchida et al. JAMA Neurol. .

Erratum in

  • Error in Table.
    [No authors listed] [No authors listed] JAMA Neurol. 2023 Feb 1;80(2):216. doi: 10.1001/jamaneurol.2022.4331. JAMA Neurol. 2023. PMID: 36508207 Free PMC article. No abstract available.

Abstract

Importance: 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.

Objective: To compare the efficacy and safety of EVT according to ASPECTS 3 or less vs 4 to 5.

Design, setting, and participants: 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.

Interventions: Patients were randomly assigned to EVT with medical therapy or medical therapy alone.

Main outcomes and measures: Modified Rankin Scale (mRS) score at 90 days and symptomatic and any intracranial hemorrhage within 48 hours.

Results: 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).

Conclusions and relevance: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT03702413.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Uchida reports lecturer fees from Daiichi Sankyo, Bristol Myers Squibb, Stryker, and Medtronic during the conduct of the study. Dr Shindo reports lecturer fees from Medtronic, Kaneka, Stryker, Daiichi Sankyo, Asahi-Intec, Ezai, Bayer, Abbott Medical, Medico’s Hirata, and Johnson & Johnson during the conduct of the study. Dr Yoshimura reports research grants from Stryker, Siemens Healthineers, Bristol Myers Squibb, Sanofi, Eisai, Daiichi Sankyo, Teijin Pharma, Chugai Pharmaceutical, Healios, Asahi Kasei Medical, Kowa, and CSL Behring and lecturer fees from Stryker, Medtronic, Johnson & Johnson, Kaneka, Terumo, Biomedical Solutions, Boehringer-Ingelheim, Daiichi Sankyo, Bayer, and Bristol Meyers Squibb during the conduct of the study. Dr Toyoda reports lecturer fees from Otsuka, Novartis, Bayer, Daiichi Sankyo, Bristol Myers Squibb, and Abbott Medical. Dr Sakai reports research grants from Biomedical Solutions, Medtronic, and Terumo; lecturer fees from Asahi-Intec, Biomedical Solutions, Medtronic, and Terumo; and membership on the advisory boards for Johnson & Johnson, Medtronic, and Terumo outside the submitted work. Dr Yamagami discloses research grants from Bristol Myers Squibb and lecturer fees from Stryker, Medtronic, Terumo, Johnson & Johnson, Biomedical Solutions, and Medico’s Hirata during the conduct of the study; and membership of the advisory boards for Daiichi Sankyo, grants from Bristol Myers Squibb, and personal fees from Daiichi Sankyo outside the submitted work. Dr Matsumaru reports lecturer fees from Medtronic, Stryker, Terumo, Johnson & Johnson, Kaneka, and Jimro during the conduct of the study and personal fees from EP Medical Consulting outside the submitted work. Dr Matsumoto reports lecturer 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, EP-CRSU, Amgen Astellas BioPharma, Alexion, Eisai, Kyowa Kirin, Daiichi Sankyo, Teijin, Medtronic, Bristol Myers Squibb, Bayer, Boehringer-Ingelheim, and Helios and lecturer fees from Daiichi Sankyo, Boehringer Ingelheim, Bristol Myers Squibb, Bayer, Takeda, Medtronic, Otsuka, Alexion, Nippon, Chugai, Kyowa Kirin, Abbott, Shire PLC, Sanofi, CSL Behring, Novartis, Toa Eiyo, Medico’s Hirata, and Helios. Dr Inoue reports lecturer fees from Bayer, Bristol Myers Squibb, and Medico’s Hirata and manuscript fees from Gakken and Hokuryukan. Dr Beppu reports manuscript fees from Medicus Shuppan during the conduct of the study. Dr Sakakibara reports manuscript fees from Medicus Shuppan during the conduct of the study. Dr Morimoto reports lecturer fees from AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, Japan Lifeline, Kowa, Toray, and Tsumura; manuscript fees from Bristol Myers Squibb and Kowa; and serving on advisory boards for Novartis and Teijin. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Study Flow Diagram
ASPECTS indicates Alberta Stroke Program Early Computed Tomography Score; EVT, endovascular therapy; RESCUE-Japan LIMIT, Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism—Japan Large Ischemic Core Trial.
Figure 2.
Figure 2.. Distribution of Modified Rankin Scale (mRS) Score at 90 Days
ASPECTS indicates Alberta Stroke Program Early Computed Tomography Score; EVT, endovascular therapy.
See this image and copyright information in PMC

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