美国库伯大学Tudor G Jovin团队对不同时间点血栓切除术治疗前循环卒中的临床益处进行了个体患者数据的荟萃分析。该项研究成果发表在2021年11月11日出版的《柳叶刀》上。

研究血栓切除术治疗前循环近端大血管闭塞卒中益处的试验纳入了被认为具有可挽救脑组织的患者，这些患者被随机分配到从最后一次观察良好起6小时内和24小时内（取决于研究方案）接受血栓切除术。该研究旨在通过对单个患者数据的荟萃分析，来评估整体和预先指定的亚组中血栓切除术的益处。

研究组检索2010年1月1日至2021年3月1日对血管内卒中治疗的随机对照试验，进行系统回顾和个体患者数据荟萃分析。主要结局是90天时改良Rankin量表（mRS）的失能，通过有序逻辑回归分析。关键安全性结局是症状性脑出血和90天内的死亡率。

在符合17项筛选已发表随机试验纳入标准的六项试验中共包括505名参与者，其中干预组266名，对照组239名，平均年龄为68.6岁，259名（51.3%）为女性。主要结局分析显示，血栓切除术未经校正的共同优势比（OR）为2.42，校正后的OR为2.54。

血栓切除术组患者在日常生活活动中的独立性（mRS 0-2）显著高于单纯最佳药物治疗组（分别为45.9%与19.3%）。干预组和对照组患者的90天死亡率分别为16.5%和19.3%，症状性脑出血发生率分别为5.3%和3.3%，组间差异均不显著。

根据年龄、性别、基线卒中严重程度、血管闭塞部位、基线阿尔伯塔卒中计划早期CT评分和表现方式确定的亚组之间未发现治疗效果的异质性；在12-24小时内血栓切除的治疗效果优于在6-12小时内血栓切除。

该发现加强了血管内血栓切除术对6-24小时可逆性脑缺血患者有益的证据，并与临床实践相关。研究结果表明，对于这些患者，不应根据6-24小时时间窗内的表现方式或表现时间点拒绝血栓切除术。

附：英文原文

Title: Thrombectomy for anterior circulation stroke beyond 6 h from time last known well (AURORA): a systematic review and individual patient data meta-analysis

Author: Tudor G Jovin, Raul G Nogueira, Maarten G Lansberg, Andrew M Demchuk, Sheila O Martins, J Mocco, Marc Ribo, Ashutosh P Jadhav, Santiago Ortega-Gutierrez, Michael D Hill, Fabricio O Lima, Diogo C Haussen, Scott Brown, Mayank Goyal, Adnan H Siddiqui, Jeremy J Heit, Bijoy K Menon, Stephanie Kemp, Ron Budzik, Xabier Urra, Michael P Marks, Vincent Costalat, David S Liebeskind, Gregory W Albers

Issue&Volume: 2021-11-11

Abstract:

Background

Trials examining the benefit of thrombectomy in anterior circulation proximal large vessel occlusion stroke have enrolled patients considered to have salvageable brain tissue, who were randomly assigned beyond 6 h and (depending on study protocol) up to 24 h from time last seen well. We aimed to estimate the benefit of thrombectomy overall and in prespecified subgroups through individual patient data meta-analysis.

Methods

We did a systematic review and individual patient data meta-analysis between Jan 1, 2010, and March 1, 2021, of randomised controlled trials of endovascular stroke therapy. In the Analysis Of Pooled Data From Randomized Studies Of Thrombectomy More Than 6 Hours After Last Known Well (AURORA) collaboration, the primary outcome was disability on the modified Rankin Scale (mRS) at 90 days, analysed by ordinal logistic regression. Key safety outcomes were symptomatic intracerebral haemorrhage and mortality within 90 days.

Findings

Patient level data from 505 individuals (n=266 intervention, n=239 control; mean age 68·6 years [SD 13·7], 259 [51·3%] women) were included from six trials that met inclusion criteria of 17 screened published randomised trials. Primary outcome analysis showed a benefit of thrombectomy with an unadjusted common odds ratio (OR) of 2·42 (95% CI 1·76–3·33; p<0·0001) and an adjusted common OR (for age, gender, baseline stroke severity, extent of infarction on baseline head CT, and time from onset to random assignment) of 2·54 (1·83–3·54; p<0·0001). Thrombectomy was associated with higher rates of independence in activities of daily living (mRS 0–2) than best medical therapy alone (122 [45·9%] of 266 vs 46 [19·3%] of 238; p<0·0001). No significant difference between intervention and control groups was found when analysing either 90-day mortality (44 [16·5%] of 266 vs 46 [19·3%] of 238) or symptomatic intracerebral haemorrhage (14 [5·3%] of 266 vs eight [3·3%] of 239). No heterogeneity of treatment effect was noted across subgroups defined by age, gender, baseline stroke severity, vessel occlusion site, baseline Alberta Stroke Program Early CT Score, and mode of presentation; treatment effect was stronger in patients randomly assigned within 12–24 h (common OR 5·86 [95% CI 3·14–10·94]) than those randomly assigned within 6–12 h (1·76 [1·18–2·62]; pinteraction=0·0087).

Interpretation

These findings strengthen the evidence for benefit of endovascular thrombectomy in patients with evidence of reversible cerebral ischaemia across the 6–24 h time window and are relevant to clinical practice. Our findings suggest that in these patients, thrombectomy should not be withheld on the basis of mode of presentation or of the point in time of presentation within the 6–24 h time window.

DOI: 10.1016/S0140-6736(21)01341-6

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01341-6/fulltext