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大缺血性卒中血管内血栓切除术结局的性别差异:SELECT2亚分析

Sex-Based Differences in Endovascular Thrombectomy Outcomes for Large Ischemic Stroke: A SELECT2 Subanalysis.

作者信息

Tsai Jenny P, Nguyen Thanh N, Pujara Deep K, Fifi Johanna T, Sundararajan Sophia, Schaafsma Joanna D, Pérez de la Ossa Natalia, Abraham Michael G, Chen Michael, Hussain Muhammad S, Ortega-Gutierrez Santiago, Johns Hannah T, Duncan Kelsey R, Churilov Leonid, Lechtenberg Colleen G, Slavin Sabreena J, Opaskar Amanda, de Lera Mercedes, Lara-Rodriguez Blanca, Quesada Helena, Fournier Lauren E, Defta Dana M, Shaker Faris, Sitton Clark W, Sharrief Anjail Z, Grotta James C, Hill Michael D, Ribo Marc, Hassan Ameer E, Campbell Bruce C V, Sila Cathy, Tjoumakaris Stavropoula I, Sarraj Amrou

机构信息

Neurosurgery, Cleveland Clinic, OH (J.P.T.).

Neurology, Boston Medical Center, MA (T.N.N.).

出版信息

Stroke. 2025 Feb;56(2):294-304. doi: 10.1161/STROKEAHA.124.049307. Epub 2025 Jan 2.

Abstract

BACKGROUND

Several social and biological factors are shown to differentially affect stroke outcomes between men and women. We evaluated whether clinical outcomes and endovascular thrombectomy (EVT) treatment effects differed between the sexes in patients presenting with large ischemic stroke.

METHODS

The SELECT2 trial (A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke) was a randomized controlled trial assessing the efficacy and safety of EVT in patients with large strokes across the United States, Canada, Europe, Australia, and New Zealand between October 2019 and September 2022. In this subanalysis, baseline characteristics and clinical and imaging outcomes were compared between women and men, each further divided into cohorts receiving medical treatment without and with EVT. Functional outcomes at 90-day and 1-year follow-ups were assessed using regression models, adjusting for potential confounders. Sex-related effect modification was examined.

RESULTS

Women accounted for 145 (41%) of 352 patients enrolled in the SELECT2 trial. Seventy-one (49%) of 145 women and 109 (53%) of 207 men underwent EVT. Endovascular intervention was associated with better functional outcomes (women: adjusted generalized odds ratio, 1.73 [1.22-2.45]; men: adjusted generalized odds ratio, 1.66 [1.24-2.23]; -int: 0.94), functional independence (women: EVT, 20% versus medical management, 4%; adjusted risk ratio [aRR], 5.04 [1.59-16.02]; men: EVT, 20% versus medical management, 9%; aRR, 1.99 [0.99-4.02]; -int: 0.20), and independent ambulation (women: EVT, 39% versus medical management, 16%; aRR, 2.44 [1.40-4.24]; men: EVT, 38% versus medical management, 20%; aRR, 1.98 [1.29-3.03]; -int: 0.67) in both men and women at 90-day follow-up, without significant heterogeneity. Similar results were observed at 1-year follow-up. In women, as age increased (aRR, 0.97 [95% CI, 0.95-0.99]; =0.004 per year) and core volume estimates increased (aRR, 0.99 [95% CI, 0.98-1.00]; =0.015 per mL increase), the rate of independent ambulation after EVT decreased. A similar association of age and core volume was seen in men.

CONCLUSIONS

EVT treatment benefit was maintained in both women and men, with higher rates of functional independence and independent ambulation as compared with medical management. Age and estimated core infarct volume were independently associated with independent ambulation in both male and female patients. EVT should be equally considered for patients of both sexes meeting large core eligibility criteria.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT03876457.

摘要

背景

多项社会和生物学因素显示对男性和女性的卒中结局有不同影响。我们评估了大面积缺血性卒中患者的临床结局和血管内血栓切除术(EVT)治疗效果在性别之间是否存在差异。

方法

SELECT2试验(一项优化急性缺血性卒中血管内治疗患者选择的随机对照试验)是一项随机对照试验,于2019年10月至2022年9月在美国、加拿大、欧洲、澳大利亚和新西兰评估EVT对大面积卒中患者的疗效和安全性。在这项亚分析中,比较了女性和男性的基线特征、临床和影像学结局,每组又进一步分为接受单纯药物治疗和接受EVT联合药物治疗的队列。使用回归模型评估90天和1年随访时的功能结局,并对潜在混杂因素进行校正。研究了性别相关的效应修饰。

结果

SELECT2试验纳入的352例患者中,女性有145例(41%)。145例女性中有71例(49%)、207例男性中有109例(53%)接受了EVT。血管内介入治疗与更好的功能结局相关(女性:校正后的广义优势比,1.73[1.22 - 2.45];男性:校正后的广义优势比,1.66[1.24 - 2.23];交互作用:0.94)、功能独立性(女性:EVT组为20%,单纯药物治疗组为4%;校正风险比[aRR],5.04[1.59 - 16.02];男性:EVT组为20%,单纯药物治疗组为9%;aRR,1.99[0.99 - 4.02];交互作用:0.20)以及90天随访时男性和女性的独立行走能力(女性:EVT组为39%,单纯药物治疗组为16%;aRR,2.44[1.40 - 4.24];男性:EVT组为38%,单纯药物治疗组为20%;aRR,1.98[1.29 - 3.03];交互作用:-0.67),且无显著异质性。1年随访时观察到类似结果。在女性中,随着年龄增加(aRR,0.97[95%可信区间,0.95 - 0.99];每年=-0.004)和核心体积估计值增加(aRR,0.99[95%可信区间,0.98 - 1.00];每增加1 mL=-0.015),EVT后独立行走的比例下降。在男性中也观察到年龄和核心体积的类似关联。

结论

EVT治疗对男性和女性均有益,与单纯药物治疗相比,功能独立性和独立行走能力的比例更高。年龄和估计的核心梗死体积在男性和女性患者中均与独立行走独立相关。对于符合大面积核心梗死标准的男女患者,均应同样考虑EVT治疗。

注册信息

网址:https://www.clinicaltrials.gov;唯一标识符:NCT03876457。

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