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Endovascular treatment in anterior circulation stroke beyond 6.5 hours after onset or time last seen well: results from the MR CLEAN Registry
Stroke and Vascular Neurology ( IF 5.9 ) Pub Date : 2021-12-01 , DOI: 10.1136/svn-2020-000803
Luuk Dekker 1 , Esmee Venema 2, 3 , F Anne V Pirson 4 , Charles B L M Majoie 5 , Bart J Emmer 5 , Ivo G H Jansen 5 , Maxim J H L Mulder 6 , Robin Lemmens 7, 8, 9 , Robert-Jan B Goldhoorn 4 , Marieke J H Wermer 1 , Jelis Boiten 10 , Geert J Lycklama À Nijeholt 11 , Yvo B W E M Roos 12 , Adriaan C G M van Es 11, 13 , Hester F Lingsma 3 , Diederik W J Dippel 6 , Wim H van Zwam 14 , Robert J van Oostenbrugge 4 , Ido R van den Wijngaard 1, 10 ,
Affiliation  

Background Randomised controlled trials with perfusion selection have shown benefit of endovascular treatment (EVT) for ischaemic stroke between 6 and 24 hours after symptom onset or time last seen well. However, outcomes after EVT in these late window patients without perfusion imaging are largely unknown. We assessed their characteristics and outcomes in routine clinical practice. Methods The Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands Registry, a prospective, multicentre study in the Netherlands, included patients with an anterior circulation occlusion who underwent EVT between 2014 and 2017. CT perfusion was no standard imaging modality. We used adjusted ordinal logistic regression analysis to compare patients treated within versus beyond 6.5 hours after propensity score matching on age, prestroke modified Rankin Scale (mRS), National Institutes of Health Stroke Scale, Alberta Stroke Programme Early CT Score (ASPECTS), collateral status, location of occlusion and treatment with intravenous thrombolysis. Outcomes included 3-month mRS score, functional independence (defined as mRS 0–2), and death. Results Of 3264 patients who underwent EVT, 106 (3.2%) were treated beyond 6.5 hours (median 8.5, IQR 6.9–10.6), of whom 93 (87.7%) had unknown time of stroke onset. CT perfusion was not performed in 87/106 (80.2%) late window patients. Late window patients were younger (mean 67 vs 70 years, p<0.04) and had slightly lower ASPECTS (median 8 vs 9, p<0.01), but better collateral status (collateral score 2–3: 68.3% vs 57.7%, p=0.03). No differences were observed in proportions of functional independence (43.3% vs 40.5%, p=0.57) or death (24.0% vs 28.9%, p=0.28). After matching, outcomes remained similar (adjusted common OR for 1 point improvement in mRS 1.04, 95% CI 0.56 to 1.93). Conclusions Without the use of CT perfusion selection criteria, EVT in the 6.5–24-hour time window was not associated with poorer outcome in selected patients with favourable clinical and CT/CT angiography characteristics. randomised controlled trials with lenient inclusion criteria are needed to identify more patients who can benefit from EVT in the late window. Individual patient data cannot be made available, because no patient approval has been obtained for sharing data, even in coded form. However, syntax and output files of statistical analyses can be made available upon reasonable request.

中文翻译:

前循环卒中发病后超过 6.5 小时或最后一次观察良好的血管内治疗:来自 MR CLEAN Registry 的结果

背景 灌注选择的随机对照试验表明,血管内治疗 (EVT) 在症状发作后 6 至 24 小时或最后一次观察良好时对缺血性卒中有益。然而,在这些没有灌注成像的晚期窗口患者中,EVT 后的结果在很大程度上是未知的。我们评估了他们在常规临床实践中的特征和结果。方法 荷兰登记处血管内治疗急性缺血性卒中的多中心随机临床试验是一项在荷兰进行的前瞻性、多中心研究,纳入了 2014 年至 2017 年间接受 EVT 的前循环闭塞患者。CT 灌注不是标准的成像方式。我们使用调整后的序数逻辑回归分析来比较接受治疗的患者在 6 以内和 6 岁以上。年龄倾向评分匹配后 5 小时,卒中前改良 Rankin 量表 (mRS)、美国国立卫生研究院卒中量表、艾伯塔省卒中计划早期 CT 评分 (ASPECTS)、侧支状态、闭塞位置和静脉溶栓治疗。结果包括 3 个月的 mRS 评分、功能独立性(定义为 mRS 0-2)和死亡。结果 在接受 EVT 的 3264 名患者中,106 名(3.2%)的治疗时间超过 6.5 小时(中位数 8.5,IQR 6.9-10.6),其中 93 名(87.7%)的卒中发病时间未知。87/106 (80.2%) 晚窗患者未进行 CT 灌注。晚窗患者更年轻(平均 67 岁 vs 70 岁,p<0.04),ASPECTS 略低(中位数 8 vs 9,p<0.01),但侧支状态更好(侧支评分 2-3:68.3% vs 57.7%,p =0.03)。在功能独立(43.3% vs 40.5%,p=0.57)或死亡(24.0% vs 28.9%,p=0.28)的比例上没有观察到差异。匹配后,结果保持相似(mRS 1.04 改善 1 点的调整共同 OR,95% CI 0.56 至 1.93)。结论 在不使用 CT 灌注选择标准的情况下,6.5-24 小时时间窗内的 EVT 与临床和 CT/CT 血管造影特征良好的选定患者的较差结果无关。需要具有宽松纳入标准的随机对照试验来确定更多可以在晚期窗口期从 EVT 中受益的患者。无法提供个人患者数据,因为共享数据未获得患者批准,即使是编码形式的数据也是如此。但是,可以根据合理要求提供统计分析的语法和输出文件。
更新日期:2021-12-24
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