Recent evidence suggests a beneficial effect of endovascular thrombectomy in acute ischaemic stroke with large infarct; however, previous trials have relied on multimodal brain imaging, whereas non-contrast CT is mostly used in clinical practice. In a prospective multicentre, open-label, randomised trial, patients with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and a large established infarct indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3–5 were randomly assigned using a central, web-based system (using a 1:1 ratio) to receive either endovascular thrombectomy with medical treatment or medical treatment (ie, standard of care) alone up to 12 h from stroke onset. The study was conducted in 40 hospitals in Europe and one site in Canada. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days, assessed by investigators masked to treatment assignment. The primary analysis was done in the intention-to-treat population. Safety endpoints included mortality and rates of symptomatic intracranial haemorrhage and were analysed in the safety population, which included all patients based on the treatment they received. This trial is registered with , . From July 17, 2018, to Feb 21, 2023, 253 patients were randomly assigned, with 125 patients assigned to endovascular thrombectomy and 128 to medical treatment alone. The trial was stopped early for efficacy after the first pre-planned interim analysis. At 90 days, endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better outcome (adjusted common OR 2·58 [95% CI 1·60–4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46–0·98]; p=0·038). Symptomatic intracranial haemorrhage occurred in seven (6%) patients with thrombectomy and in six (5%) with medical treatment alone. Endovascular thrombectomy was associated with improved functional outcome and lower mortality in patients with acute ischaemic stroke from large vessel occlusion with established large infarct in a setting using non-contrast CT as the predominant imaging modality for patient selection. EU Horizon 2020.

中文翻译：

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血管内血栓切除术治疗已形成大面积梗死的急性缺血性卒中：多中心、开放标签、随机试验

最近的证据表明，血管内血栓切除术对伴有大面积梗塞的急性缺血性卒中具有有益作用；然而，之前的试验依赖于多模态脑成像，而临床实践中主要使用非对比CT。在一项前瞻性多中心、开放标签、随机试验中，因前循环大血管闭塞而导致急性缺血性卒中的患者以及阿尔伯塔卒中计划早期计算机断层扫描评分 (ASPECTS) 为 3-5 分的大面积梗死患者被随机分组使用基于网络的中央系统（使用 1:1 的比例）分配接受血管内血栓切除术和药物治疗或仅在中风发作后 12 小时内接受单纯药物治疗（即标准护理）。该研究在欧洲 40 家医院和加拿大 1 家医院进行。主要结果是 90 天时改良 Rankin 量表整个范围的功能结果，由不了解治疗分配的研究人员进行评估。主要分析是在意向治疗人群中进行的。安全性终点包括死亡率和症状性颅内出血发生率，并在安全人群中进行分析，其中包括基于所接受治疗的所有患者。该试验已在 , 注册。从2018年7月17日到2023年2月21日，253名患者被随机分配，其中125名患者接受血管内血栓切除术，128名患者接受单纯药物治疗。在第一次预先计划的中期分析后，该试验因疗效而提前停止。90 天时，血管内血栓切除术与改良 Rankin 量表评分分布向更好结果的转变相关（调整后的共同 OR 2·58 [95% CI 1·60–4·15]；p=0·0001）且死亡率较低（风险比 0·67 [95% CI 0·46–0·98]；p=0·038）。七名（6%）接受血栓切除术的患者出现症状性颅内出血，六名（5%）接受单纯药物治疗的患者出现症状性颅内出血。在使用非增强 CT 作为患者选择的主要成像方式的情况下，血管内血栓切除术与因大血管闭塞并已形成大梗塞而导致的急性缺血性卒中患者的功能结果改善和死亡率降低相关。欧盟地平线 2020。