Importance The optimal imaging approach for identifying patients who may benefit from endovascular thrombectomy (EVT) beyond 6 hours after they were last known well is unclear. Six randomized clinical trials (RCTs) have evaluated the efficacy of EVT vs standard medical care among patients with ischemic stroke. Objective To assess the benefits of EVT among patients with 3 baseline imaging profiles using a pooled analysis of RCTs. Data Sources The AURORA (Analysis of Pooled Data from Randomized Studies of Thrombectomy More Than 6 Hours After Last Known Well) Collaboration pooled patient-level data from the included clinical trials. Study Selection An online database search identified RCTs of endovascular stroke therapy published between January 1, 2010, and March 1, 2021, that recruited patients with ischemic stroke who were randomized between 6 and 24 hours after they were last known well. Data Extraction/Synthesis Data from the final locked database of each study were provided. Data were pooled, and analyses were performed using mixed-effects modeling with fixed effects for parameters of interest. Main Outcomes and Measures The primary outcome was reduction in disability measured by the modified Rankin Scale at 90 days. An evaluation was also performed to examine whether the therapeutic response differed based on imaging profile among patients who received treatment based on the time they were last known well. Treatment benefits were assessed among a clinical mismatch subgroup, a target perfusion mismatch subgroup, and an undetermined profile subgroup. The primary end point was assessed among these subgroups and during 3 treatment intervals (tercile 1, 360-574 minutes [6.0-9.5 hours]; tercile 2, 575-762 minutes [9.6-12.7 hours]; and tercile 3, 763-1440 minutes [12.8-24.0 hours]). Results Among 505 eligible patients, 266 (mean [SD] age, 68.4 [13.8] years; 146 women [54.9%]) were assigned to the EVT group and 239 (mean [SD] age, 68.7 [13.7] years; 126 men [52.7%]) were assigned to the control group. Among 295 patients in the clinical mismatch subgroup and 359 patients in the target perfusion mismatch subgroup, EVT was associated with reductions in disability at 90 days vs no EVT (clinical mismatch subgroup, odds ratio [OR], 3.57; 95% CI, 2.29-5.57; P < .001; target perfusion mismatch subgroup, OR, 3.13; 95% CI, 2.10-4.66; P = .001). Statistically significant benefits were observed in all 3 terciles for both subgroups, with the highest OR observed for tercile 3 (clinical mismatch subgroup, OR, 4.95; 95% CI, 2.20-11.16; P < .001; target perfusion mismatch subgroup, OR, 5.01; 95% CI, 2.37-10.60; P < .001). A total of 132 patients (26.1%) had an undetermined imaging profile and no significant treatment benefit (OR, 1.59; 95% CI, 0.82-3.06; P = .17). The interaction between treatment effects for the clinical and target perfusion mismatch subgroups vs the undetermined profile subgroup was significant (OR, 2.28; 95% CI, 1.11-4.70; P = .03). Conclusions and Relevance In this study, EVT was associated with similar benefit among patients in the clinical mismatch and target perfusion mismatch subgroups during the 6- to 24-hour treatment interval. These findings support EVT as a treatment for patients meeting the criteria for either of the imaging mismatch profiles within the 6- to 24-hour interval.

中文翻译：

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症状发作后 6 小时后血管内血栓切除术最佳患者选择的评估：AURORA 数据库的汇总分析。

重要性 确定在最后一次知晓后 6 小时后可能受益于血管内血栓切除术 (EVT) 的患者的最佳成像方法尚不清楚。六项随机临床试验 (RCT) 评估了 EVT 与标准医疗在缺血性卒中患者中的疗效。目的使用 RCT 的汇总分析评估具有 3 种基线影像学特征的患者 EVT 的益处。数据来源 AURORA（对最后一次知晓后 6 小时以上的血栓切除术随机研究的汇总数据的分析）协作汇总了来自所包含临床试验的患者水平数据。研究选择 在线数据库搜索确定了 2010 年 1 月 1 日至 2021 年 3 月 1 日之间发表的血管内卒中治疗的 RCT，该研究招募了缺血性中风患者，这些患者在他们最后一次被熟知后 6 到 24 小时内被随机分配。提供了来自每项研究的最终锁定数据库的数据提取/合成数据。汇总数据，并使用具有固定效应的混合效应模型对感兴趣的参数进行分析。主要结果和测量 主要结果是通过改良 Rankin 量表在 90 天时测量的残疾减少。还进行了一项评估，以检查治疗反应是否根据接受治疗的患者的成像特征而有所不同，这些患者基于他们最后一次熟悉的时间。在临床不匹配亚组、目标灌注不匹配亚组和未确定概况亚组中评估治疗益处。在这些亚组和 3 个治疗间隔期间评估主要终点（tercile 1，360-574 分钟 [6.0-9.5 小时]；tercile 2，575-762 分钟 [9.6-12.7 小时]；tercile 3，763-1440分钟 [12.8-24.0 小时]）。结果 在 505 名符合条件的患者中，266 名（平均 [SD] 年龄，68.4 [13.8] 岁；146 名女性 [54.9%]）被分配到 EVT 组，239 名（平均 [SD] 年龄，68.7 [13.7] 岁；126 名男性[52.7%]）被分配到对照组。在临床错配亚组的 295 名患者和目标灌注错配亚组的 359 名患者中，EVT 与 90 天时的残疾减少与无 EVT 相关（临床错配亚组，优势比 [OR]，3.57；95% CI，2.29- 5.57；P < .001；目标灌注不匹配亚组，OR，3.13；95% CI，2.10-4.66；P = .001）。两个亚组的所有 3 个三分位数均观察到统计学上显着的益处，三分位数 3 观察到的 OR 最高（临床不匹配亚组，OR，4.95；95% CI，2.20-11.16；P < .001；目标灌注不匹配亚组，OR， 5.01；95% CI，2.37-10.60；P < .001)。共有 132 名患者 (26.1%) 的影像学特征未确定，并且没有显着的治疗获益 (OR, 1.59; 95% CI, 0.82-3.06; P = .17)。临床和目标灌注不匹配亚组与未确定概况亚组的治疗效果之间的相互作用是显着的（OR，2.28；95% CI，1.11-4.70；P = .03）。结论和相关性 在这项研究中，EVT 与 6 至 24 小时治疗间隔期间临床不匹配和目标灌注不匹配亚组患者的相似益处相关。