晚期窗内大脑中动脉M2段闭塞的血管内治疗：CLEAR研究分析

Endovascular Therapy for Late-Window M2-Segment Middle Cerebral Artery Occlusion: Analysis of the CLEAR Study.

作者信息

Winzer Simon, Kaiser Daniel P O, Qureshi Muhammad M, Castonguay Alicia C, Strbian Daniel, Nogueira Raul G, Nagel Simon, Raymond Jean, Abdalkader Mohamad, Demeestere Jelle, Marto João Pedro, Yamagami Hiroshi, Tanaka Kanta, Sheth Sunil A, Dusart Anne, Michel Patrik, Olive Gadea Marta, Ribo Marc, Zaidat Osama O, Haussen Diogo C, Henon Hilde, Mohammaden Mahmoud H, Möhlenbruch Markus A, Siegler James E, Puri Ajit S, Kaesmacher Johannes, Klein Piers, Tomppo Liisa, Caparros Francois, Ramos João Nuno, Jumaa Mouhammad, Zaidi Syed, Martinez-Majander Nicolas, Nannoni Stefania, Vandewalle Lieselotte, Bellante Flavio, Galecio-Castillo Milagros, Salazar-Marioni Sergio, Virtanen Pekka, Wouters Anke, Ventura Rita, Jesser Jessica, Mujanovic Adnan, Shu Liqi, Qureshi Abiya, Qiu Zhongming, Masoud Hesham E, Requena Manuel, Sillanpää Mikko, Hu Wei, Lin Eugene, Cordonnier Charlotte, Roy Daniel, Yaghi Shadi, Strambo Davide, Fischer Urs, Ortega-Gutierrez Santiago, Lemmens Robin, Ringleb Peter A, Nguyen Thanh N, Puetz Volker

机构信息

Neurology (S.W., V.P.), Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany.

Dresden Neurovascular Center (S.W., D.P.O.K., V.P.), Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany.

出版信息

Stroke. 2025 Jul;56(7):1671-1680. doi: 10.1161/STROKEAHA.124.048840. Epub 2025 May 22.

DOI:10.1161/STROKEAHA.124.048840

PMID:40405459

Abstract

BACKGROUND

There is uncertainty about whether patients with M2 occlusion benefit from endovascular therapy (EVT) in the late (6-24-hour) time window. We evaluated the clinical outcomes of patients with M2 occlusion selected for EVT compared with those who received medical management (MM) in the late window.

METHODS

This multinational cohort study was conducted at 66 sites across 10 countries (January 2014 to May 2022). We included consecutive patients with late-window stroke due to M2 occlusion, baseline National Institutes of Health Stroke Scale score of ≥5, and premorbid modified Rankin Scale score of ≤2 who received EVT or MM alone. The primary end point was 90-day ordinal shift in the modified Rankin Scale score. Safety end points were symptomatic intracranial hemorrhage and 90-day mortality. Differences in outcomes were determined using inverse probability of treatment weighting-adjusted logistic regression models.

RESULTS

Among 5098 patients, 496 met inclusion criteria (median [interquartile range] age, 74 years [62-81 years]; baseline National Institutes of Health Stroke Scale score, 12 [8-17]), of whom 394 (79.4%) received EVT and 102 (20.6%) MM. In inverse probability of treatment weighting adjusted analyses, there was no favorable 90-day ordinal modified Rankin Scale shift (odds ratio, 1.39 [95% CI, 0.92-2.12]) and no difference of functional independence rates (modified Rankin Scale score of 0-2; odds ratio, 1.72 [95% CI, 0.93-3.15]) with EVT compared with MM. Moreover, symptomatic intracranial hemorrhage risk (odds ratio, 3.46 [95% CI, 0.50-23.92]) and 90-day mortality (odds ratio, 1.11 [95% CI, 0.66-1.87]) were not statistically different between treatment groups.

CONCLUSIONS

In patients with M2 occlusion in the 6- to 24-hour time window, there was no difference in disability outcomes or symptomatic intracranial hemorrhage risk between patients treated with EVT compared with MM. Results of ongoing randomized trials will provide further insight.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT04096248.

摘要

背景

对于大脑中动脉M2段闭塞的患者在晚期（6 - 24小时）时间窗内是否能从血管内治疗（EVT）中获益尚不确定。我们评估了在晚期时间窗内接受EVT治疗的M2段闭塞患者与接受药物治疗（MM）的患者的临床结局。

方法

这项多国队列研究在10个国家的66个地点进行（2014年1月至2022年5月）。我们纳入了因M2段闭塞导致晚期卒中、美国国立卫生研究院卒中量表基线评分≥5且病前改良Rankin量表评分≤2的连续患者，这些患者单独接受了EVT或MM治疗。主要终点是改良Rankin量表评分在90天时的序贯变化。安全性终点是有症状性颅内出血和90天死亡率。使用治疗权重逆概率调整的逻辑回归模型确定结局的差异。

结果

在5098例患者中，496例符合纳入标准（年龄中位数[四分位间距]为74岁[62 - 81岁]；美国国立卫生研究院卒中量表基线评分，12[8 - 17]），其中394例（79.4%）接受了EVT治疗，102例（20.6%）接受了MM治疗。在治疗权重逆概率调整分析中，与MM相比，EVT组在90天时改良Rankin量表评分没有出现有利的序贯变化（优势比，1.39[95%CI，0.92 - 2.12]），功能独立率（改良Rankin量表评分为0 - 2；优势比，1.72[95%CI，0.93 - 3.15]）也没有差异。此外，治疗组之间有症状性颅内出血风险（优势比，3.46[95%CI，0.50 - 23.92]）和90天死亡率（优势比，1.11[95%CI，0.66 - 1.87]）在统计学上没有差异。