Clinical Severity and Outcomes in Large Infarcts With Endovascular Therapy: A Post Hoc Analysis of the ANGEL-ASPECT Trial

医学 改良兰金量表 冲程(发动机) 析因分析 随机对照试验 优势比 内科学 临床试验 心脏病学 外科 缺血性中风 缺血 机械工程 工程类
作者
Qixuan Lu,Lina Zheng,Ximing Nie,Mengxing Wang,Wanying Duan,Xin Liu,Zhe Zhang,Miaowen Wen,Zhonghua Yang,Xinyi Leng,Yuesong Pan,Thanh N. Nguyen,Liping Liu
出处
期刊:Stroke [Lippincott Williams & Wilkins]
标识
DOI:10.1161/strokeaha.124.049315
摘要

BACKGROUND: Endovascular therapy (EVT) has been proven effective for patients with acute ischemic stroke with large infarcts. This study aimed to explore the impact of clinical severity on the efficacy of EVT in such patients. METHODS: This was a post hoc analysis of the ANGEL-ASPECT trial (Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients With a Large Infarct Core), a randomized controlled trial that enrolled patients from 46 centers across China between October 2, 2020, and May 18, 2022. These patients had large infarcts (defined as Alberta Stroke Program Early CT Score of 3–5 or infarct-core volume 70–100 mL) due to anterior-circulation large vessel occlusion within 24 hours after stroke onset with a National Institutes of Health Stroke Scale score of 6 to 30. Patients were randomized into either the EVT group or the medical management alone (MM) group. For this analysis, we categorized the patients into 2 subgroups: moderate stroke and severe stroke, based on a baseline National Institutes of Health Stroke Scale score of either <20 or ≥20. The primary outcome was the ordinal 90-day modified Rankin Scale score (0, no symptoms, to 6, death). RESULTS: Among 455 eligible patients, 347 (76.3%) presented with moderate stroke (170 received EVT, 177 underwent MM), and 108 (23.7%) had severe stroke (60 received EVT, 48 underwent MM). A significant shift toward better outcomes in the 90-day modified Rankin Scale distribution was observed in the EVT group compared with the MM group (generalized odds ratio, 1.66 [95% CI, 1.29–2.13]; P <0.001) among patients with moderate stroke. However, this was not the case for those with severe stroke (generalized odds ratio, 1.06 [95% CI, 0.54–2.10]; P =0.87), indicating a significant interaction ( P =0.03). CONCLUSIONS: In patients with acute large infarcts, EVT was associated with improved functional outcomes compared with MM in patients with moderate stroke. However, no significant difference was observed in patients with severe stroke. Therefore, stroke severity should be considered when selecting patients with large infarcts for EVT. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04551664.
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