不同灌注不匹配特征下因中等血管闭塞所致急性卒中的血栓切除术：ESCAPE-MeVO试验的事后分析。
完整摘要 · 中文译文
重要性：近期试验尚未证明血管内血栓切除术（EVT）在中等血管闭塞（MeVO）所致急性卒中中优于药物治疗。然而，对于经选择的具有有利灌注特征的患者是否可能从EVT中获益，仍不确定。 目的：探讨MeVO卒中中灌注不匹配特征与功能结局之间的关联，并确定这些特征是否会改变EVT的效果。 设计、背景与参与者：本研究是对ESCAPE-MeVO（血管内治疗改善中等血管闭塞结局）试验的事后分析，该试验为一项多中心随机临床试验，于2022年4月至2024年6月在北美、欧洲和英国开展，随访90天。试验参与者包括在最后已知正常时间后12小时内就诊且存在可挽救脑组织证据的急性MeVO卒中患者。该分析仅纳入基线灌注成像可判读的患者。数据分析时间为2026年3月至7月。 干预措施：随机分配至EVT加常规治疗组或单纯常规治疗组。 主要结局与指标：主要结局为90天有序改良Rankin量表（mRS）评分。次要结局包括24小时随访梗死体积以及90天mRS评分0至1分和0至2分。灌注不匹配比值和体积定义为严重低灌注区与缺血核心之间的比值和差值，体积阈值由特定部位的后处理软件确定。 结果：在530例入组患者中，309例（58.3%）可 可获得基线灌注成像并被纳入本研究（EVT：n = 146；常规治疗：n = 163）。患者中位（IQR）年龄为73（63-82）岁，其中141例（45.6%）为女性。中位（IQR）灌注不匹配体积为37.2（22.1-57.2）mL，中位（IQR）不匹配比率为6.1（2.8-10.0）。90天mRS有序评分与灌注不匹配体积（校正比值比[AOR]，每增加10 mL为1.03 [95% CI, 0.99-1.07]）或灌注不匹配比率（AOR，每增加1个单位为1.03 [95% CI, 0.97-1.09]）均无相关性。在90天有序mRS上，EVT疗效未因灌注不匹配体积或比率而改变。次要结局和亚组的结果一致。 结论与相关性：在这项急性MeVO卒中的探索性事后分析中，灌注不匹配特征与功能结局无关，也未改变EVT的疗效。这些发现提示，在ESCAPE-MeVO试验中，基于当前所用阈值和截断值的灌注成像特征未能识别出可能从EVT中获益的患者。 试验注册：ClinicalTrials.gov标识符：NCT05151172。
完整摘要 · 英文原文
IMPORTANCE: Recent trials have not demonstrated a benefit of endovascular thrombectomy (EVT) over medical therapy in acute stroke due to medium vessel occlusion (MeVO). However, it remains uncertain whether selected patients with favorable perfusion may benefit from EVT. OBJECTIVE: To investigate the association between perfusion mismatch profiles and functional outcomes in MeVO stroke and to determine whether these profiles modify the effect of EVT. DESIGN, SETTING, AND PARTICIPANTS: This study was a post hoc analysis of ESCAPE-MeVO (Endovascular Treatment to Improve Outcomes for Medium Vessel Occlusion), a multicenter randomized clinical trial conducted in North America, Europe, and the United Kingdom between April 2022 and June 2024, with a 90-day follow-up. Trial participants included patients with acute MeVO stroke presenting within 12 hours from last known well and evidence of salvageable brain tissue. This analysis included only patients with interpretable baseline perfusion imaging. Data were analyzed from March to July 2026. INTERVENTIONS: Randomization to EVT plus usual care vs usual care alone. MAIN OUTCOMES AND MEASURES: The primary outcome was the 90-day ordinal modified Rankin Scale (mRS) score. Secondary outcomes included 24-hour follow-up infarct volume and 90-day mRS score of 0 to 1 and 0 to 2. Perfusion mismatch ratio and volume were defined as the ratio and difference between the critically hypoperfused area and the ischemic core, with volume thresholds defined by site-specific postprocessing software. RESULTS: Of 530 enrolled patients, 309 (58.3%) had available baseline perfusion imaging and were included in this study (EVT: n = 146; usual care: n = 163). Patient median (IQR) age was 73 (63-82) years, and 141 (45.6%) were women. Median (IQR) perfusion mismatch volume was 37.2 (22.1-57.2) mL, and the median (IQR) mismatch ratio was 6.1 (2.8-10.0). Ordinal 90-day mRS score was not associated with perfusion mismatch volume (adjusted odds ratio [AOR], 1.03 [95% CI, 0.99-1.07] per 10-mL increase) or perfusion mismatch ratio (AOR, 1.03 [95% CI, 0.97-1.09] per 1-unit increase). There was no modification of EVT effect by perfusion mismatch volume or ratio on ordinal 90-day mRS. Results were consistent across secondary outcomes and subgroups. CONCLUSIONS AND RELEVANCE: In this exploratory post hoc analysis of acute MeVO stroke, perfusion mismatch profiles were not associated with functional outcomes and did not modify the effect of EVT. These findings suggest that perfusion imaging profiles based on currently used thresholds and cutoffs did not identify patients likely to benefit from EVT in the ESCAPE-MeVO trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05151172.