Background Stroke etiology might influence the clinical outcomes in patients with large vessel occlusion receiving endovascular treatment (EVT) with or without thrombolysis.
Objective To examine whether stroke etiology resulted in different efficacy and safety in patients treated with EVT-alone or EVT preceded by intravenous alteplase (combined therapy).
Methods We assessed the efficacy and safety of treatment strategy based on prespecified stroke etiology, cardioembolism (CE), large-artery atherosclerosis (LAA), and undetermined cause (UC) for patients enrolled in the DIRECT-MT trial. The primary outcome was the modified Rankin Scale (mRS) score at 90 days. Multivariate ordinal logistic regression analysis was used to calculate the adjusted common OR for a shift of better mRS score for EVT-alone versus combined therapy. A term was entered to test for interaction.
Results In this study, 656 patients were grouped into three prespecified stroke etiologic subgroups. The adjusted common ORs for improvement in the 90-day ordinal mRS score with EVT-alone were 1.2 (95% CI 0.8 to 1.8) for CE, 1.6 (95% CI 0.8 to 3.3) for LAA, and 0.8 (95% CI 0.5 to 1.3) for UC. Compared with CE, EVT-alone was more likely to result in an mRS score of 0–1 (pinteraction=0.047) and extended Thrombolysis in Cerebral Infarction ≥2b (pinteraction=0.041) in the LAA group. The differences in mortality and symptomatic intracranial hemorrhage within 90 days were not significant between the subgroups (p＞0.05).
Conclusions The results did not support the hypothesis that a specific treatment strategy based on stroke etiology should be used for patients with large vessel occlusion (NCT03469206).
Data availability statement
All data relevant to the study are included in the article or uploaded as supplementary information. Not applicable.
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PX and XZ contributed equally.
Contributors PFX and XXZ contributed equally to this work. PFX, XXZ, YWZ, PFY, and JML participated in the design of this paper, wrote the manuscript, and contributed to interpretation of the data. XXZ, HJS, FS, LZ, and ZFL participated in revising the paper critically for important intellectual content. YXZ, BH, HZS, and HXH contributed to data collection and the collection of the important background information. XFY independently contributed to the statistical analysis. PFY accepted full responsible for the overall content, and all authors critically reviewed the manuscript and approved the final version.
Funding The DIRECT-MT was funded by a grant (GN-2017R0001) from the Stroke Prevention Project of the National Health Commission of the People’s Republic of China and the Wu Jieping Medical Foundation.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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