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Thrombectomy for anterior circulation stroke beyond 6 h from time last known well (AURORA): a systematic review and individual patient data meta-analysis
The Lancet ( IF 98.4 ) Pub Date : 2021-11-11 , DOI: 10.1016/s0140-6736(21)01341-6
Tudor G Jovin 1 , Raul G Nogueira 2 , Maarten G Lansberg 3 , Andrew M Demchuk 4 , Sheila O Martins 5 , J Mocco 6 , Marc Ribo 7 , Ashutosh P Jadhav 8 , Santiago Ortega-Gutierrez 9 , Michael D Hill 10 , Fabricio O Lima 11 , Diogo C Haussen 2 , Scott Brown 12 , Mayank Goyal 4 , Adnan H Siddiqui 13 , Jeremy J Heit 14 , Bijoy K Menon 15 , Stephanie Kemp 3 , Ron Budzik 16 , Xabier Urra 17 , Michael P Marks 14 , Vincent Costalat 18 , David S Liebeskind 19 , Gregory W Albers 3
Affiliation  

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. 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. 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 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 46 [19·3%] of 238) or symptomatic intracerebral haemorrhage (14 [5·3%] of 266 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]; p=0·0087). 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. Stryker Neurovascular.

中文翻译:

距上次已知时间超过 6 小时的前循环卒中血栓切除术 (AURORA):系统评价和个体患者数据荟萃分析

研究血栓切除术治疗前循环近端大血管闭塞性中风的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距离最后一次康复时间超过 6 小时(取决于研究方案)最多 24 小时。我们的目的是通过个体患者数据荟萃分析来估计血栓切除术的总体益处和预先指定的亚组中的益处。我们对2010年1月1日至2021年3月1日期间血管内卒中治疗的随机对照试验进行了系统回顾和个体患者数据荟萃分析。在对上次已知良好后超过 6 小时的血栓切除术随机研究的汇总数据进行分析 (AURORA) 合作中,主要结局是 90 天时改良 Rankin 量表 (mRS) 的残疾情况,并通过序数逻辑回归进行分析。关键的安全性结果是 90 天内有症状的脑出血和死亡率。来自 505 名个体(n=266 干预组,n=239 对照;平均年龄 68·6 岁 [SD 13·7],259 [51·3%] 女性)的患者水平数据包含在 6 项试验中,符合纳入标准 17筛选已发表的随机试验。主要结果分析显示血栓切除术的益处,未调整的共同比值比 (OR) 为 2·42(95% CI 1·76–3·33;p<0·0001)和调整后的共同比值比(针对年龄、性别、基线卒中严重程度、基线头部 CT 梗塞范围以及从发病到随机分配的时间)为 2·54 (1·83–3·54;p<0·0001)。与单独最佳药物治疗相比,血栓切除术与较高的日常生活活动独立性 (mRS 0–2) 相关(266 例中的 122 例 [45·9%] 238 例中的 46 例 [19·3%];p<0·0001) 。在分析 90 天死亡率(266 中的 44 [16·5%] 238 中的 46 [19·3%])或症状性脑出血(238 中的 14 [5·3%])时,干预组和对照组之间没有发现显着差异。 266 八 [239 中的 3·3%])。根据年龄、性别、基线卒中严重程度、血管闭塞部位、基线艾伯塔省卒中计划早期 CT 评分和表现方式定义的亚组之间,未发现治疗效果存在异质性; 12-24 小时内随机分配的患者(常见 OR 5·86 [95% CI 3·14–10·94])比 6-12 小时内随机分配的患者(1·76 [1·18- 2·62];p=0·0087)。这些发现强化了血管内血栓切除术对 6-24 小时内出现可逆性脑缺血证据的患者有益的证据,并且与临床实践相关。我们的研究结果表明,对于这些患者,不应根据就诊方式或 6-24 小时时间窗内的就诊时间点而拒绝进行血栓切除术。史赛克神经血管。
更新日期:2021-11-11
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