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Abstract
Background The efficacy of endovascular therapy (EVT) in patients with large ischemic core has been reported, but it remains unclear whether IV alteplase (IVT) has beneficial effects in addition to EVT in such patients. We evaluated the efficacy and safety of EVT with or without IVT.
Methods The RESCUE-Japan LIMIT was an open-label, prospective, multicenter, randomized clinical trial to evaluate the efficacy and safety of EVT in stroke patients with large ischemic core, defined as Alberta Stroke Program Early CT Score (ASPECTS) 3–5. This subanalysis evaluated the differences in the effects of EVT with medical care (EVT group) compared with medical care alone (No-EVT group) between those who received IVT (IVT stratum) and those who did not (No-IVT stratum) before EVT.
Results Among 202 enrolled patients, 147 (73%) did not receive IVT. In the No-IVT stratum, the modified Rankin Scale (mRS) score of 0–3 at 90 days was significantly higher in the EVT group than in the No-EVT group (31.1% vs 12.3%, OR 3.21 (95% CI 1.37 to 7.53)). In the IVT stratum, the mRS score of 0–3 was 30.8% in the EVT group and 13.8% in the No-EVT group (OR 2.78 (95% CI 0.72 to 10.7)) (interaction p=0.77). The incidence of symptomatic intracranial hemorrhage was not different between the two groups in the No-IVT stratum (OR 1.20 (95% CI 0.35 to 4.12)), but it was significantly higher in the EVT group than in the No-EVT group in the IVT stratum (11.5% vs 0%, p=0.03).
Conclusions There was no difference in efficacy of EVT with or without IVT, while IVT before EVT might increase symptomatic intracranial hemorrhage in patients with large ischemic core.
Trial registration information NCT03702413.
- Stroke
- Thrombectomy
Data availability statement
The data that support the findings of this study are available from the corresponding author on reasonable request. Takeshi Morimoto had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
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Data availability statement
The data that support the findings of this study are available from the corresponding author on reasonable request. Takeshi Morimoto had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Footnotes
Contributors SS, KU, SY, KT, NS, HY, YM, YM, KK, and TM contributed to the conception and design of this study. SS, KU, SY, KT, NS, HY, YM, YM, KK, RI, MI, FS, MN, MU, and TM contributed to the acquisition and analysis of data. SS, KU, and TM contributed to drafting the text and preparing the figures. All authors critically revised the manuscript for important intellectual content. TM is responsible for the overall content as guarantor.
Competing interests SS reports lecturer fees from Medtronic, Kaneka, Stryker, Daiichi Sankyo, Asahi-Intec, Ezai, Bayer, Abbot Medical, Medico’s Hirata and Johnson and Johnson. KU reports lecturer fees from Daiichi Sankyo, Bristol-Myers Squibb, Stryker and Medtronic. SY 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; lecturer fees from Stryker, Medtronic, Johnson. NS reports research grants from Biomedical Solutions, Medtronic and Terumo; lecturer fees from Asahi-Intec, Biomedical Solutions, Medtronic, TG medical and Terumo; membership on the advisory boards for Johnson. HY discloses research grants from Bristol-Myers Squibb; lecturer fees from Stryker, Medtronic, Terumo, Johnson; membership of the advisory boards for Daiichi Sankyo. KT reports lecture fees from Otsuka, Novartis, Bayer, Daiichi Sankyo, Bristol Myers Squibb and Abbott Medical. YuM reports lecturer fees from Medtronic, Stryker, Terumo, Johnson. YaM reports royalty from Sumitomo Bakelite and lecturer fees from Kaneka, Medico’s Hirata, Fuji Systems, GE Healthcare, Otsuka, Takeda, Century Medical, Terumo, Medtronic and Stryker. KK 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; lecturer fees from Daiichi Sankyo, Boehringer Ingelheim, Bristol-Myers Squibb, Bayer, Takeda, Medtronic, Otsuka, FP, Alexion, Nippon, Chugai, Kyowa Kirin, Abbott, Shire PLC, Sanofi, CSL Behring, Novartis, Toa Eiyo, Medico’s Hirata and Helios. MI reports lecturer fees from Bayer, Bristol-Myers Squibb, Boehringer Ingelheim and Medico’s Hirata. FS reports manuscript fees from Medicus Shuppan. MN reports lecturer fees from Stryker, Daiichi Sankyo, Biojen, Ezai, Bayer, Otuska, Pfyser, Kowa, Takeda and Abbot Medical. MU reports research grants from Pfizer and Alnylam; lecturer fees from Pfizer, Alnylam, Janssen, CSL Behring, Eisai, Takeda, Daiichi Sankyo, Otsuka, Kyowa Kirin, Chugai, Mitsubishi Tanabe, Alexion, Novartis and Agrenx. TM reports lecturer fees from AstraZeneca, Bristol-Myers Squibb, Daiichi Sankyo, Japan Lifeline, Kowa, Toray and Tsumura; manuscript fees from Bristol-Myers Squibb and Kowa; advisory board for Novartis and Teijin. RI has no conflicts of interest to report.
Provenance and peer review Not commissioned; externally peer reviewed.
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