Yuan Guangxiong, Sang Hongfei, Nguyen Thanh N, Huo Xiaochuan, Pan Yuesong, Wang Mengxing, Qiu Zhongming, Liu Lei, Xia Hong, Wu Junxiong, Long Chen, Xu Jun, Huang Feng, He Bo, Wu Derong, Wang Hailing, Feng Can, Liang Yong, Zhou Xianghong, Yang Wenbin, Huang Zhu, Xiang Youxi, Lei Libo, Saver Jeffrey L, Miao Zhongrong, Cai Xueli
From the Department of Emergency (G.Y., Lei Liu, H.X., J.W., C.L., J.X., F.H., B.H., D.W., H.W., C.F., Y.L., X.Z., W.Y., Z.H., Y.X., Libo Lei), Xiangtan Central Hospital (The Affiliated Hospital of Hunan University); Department of Neurology (H.S.), Affiliated Hangzhou First People's Hospital, Westlake University School of Medicine, China; Department of Neurology and Radiology (T.N.N.), Boston Medical Center, MA; Cerebrovascular Disease Department (X.H.), Beijing Anzhen Hospital, Capital Medical University; China National Clinical Research Center for Neurological Diseases (X.H., Y.P., M.W., Z.M.), Beijing; Interventional Neuroradiology (Y.P., M.W., Z.M.), Department of Neurology, Beijing Tiantan Hospital, Capital Medical University; Department of Neurology (Z.Q.), The 903rd Hospital of the People's Liberation Army, Hangzhou, China; Department of Neurology (J.L.S.), David Geffen School of Medicine at UCLA, Los Angeles, CA; and Department of Neurology (X.C.), the Central Hospital of Lishui, the Fifth Affiliated Hospital of Wenzhou Medical College, Lishui, Zhejiang, China.
Neurology. 2025 Jan 14;104(1):e210133. doi: 10.1212/WNL.0000000000210133. Epub 2024 Dec 9.
Randomized trials have proven the benefit of endovascular therapy (EVT) for acute large ischemic stroke. This study was to characterize the effect of time to treatment on benefit of EVT vs medical management (MM) among patients with large ischemic stroke.
This was a post hoc analysis of the Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core randomized trial. Patients who had an Alberta Stroke Program Early Computed Tomography Score of 3-5 or an ischemic core volume of 70-100 mL within 24 hours of symptom onset were treated with EVT plus MM or MM. Onset-to-expected arterial puncture time (OPT) was analyzed as a categorical variable (<6, 6-<12, and 12-24 hours) using binary logistic regression and as a continuous variable using a multivariable fractional polynomial interaction. The primary efficacy outcome was favorable outcomes (modified Rankin Scale scores 0-3) at 90 days. Safety outcomes included any intracranial hemorrhage (ICH), symptomatic ICH, and mortality.
Among 451 patients (median age 68 years; 61.4% were men; median OPT 487 minutes [interquartile range 328-802]), 226 patients received EVT and 225 patients received MM. The EVT group showed higher rates of favorable outcomes than the MM group within OPT of 6 hours (44.4% vs 29.9%, adjusted odds ratio [aOR] 2.78, 95% CI 1.22-6.32) and 6-12 hours (45.7% vs 29.6%, aOR 2.39 [95% CI 1.21-4.71]), but not in OPT beyond 12 hours (51.6% vs 41.4%, aOR 2.05 [95% CI 0.88-4.77]). The benefit became nonsignificant after OPT of 13 hours and 22 minutes. In 3 OPT intervals, the rates of symptomatic ICH and mortality were similar between EVT and MM although the rate of any ICH increased. However, no interaction effect was found (all interactions >0.10).
These findings strengthen the benefit of EVT initiated within 13 hours and 22 minutes after symptom onset compared with MM alone in patients with large ischemic stroke, but EVT should not be withheld for patients presenting beyond 13 hours and 22 minutes. Pooled analysis of larger sample sizes is needed.
ClinicalTrials.gov; NCT04551664.
This study provides Class II evidence that EVT is associated with improved functional outcomes for acute large ischemic stroke within 24 hours after last known well, with no interaction by time.
随机试验已证实血管内治疗（EVT）对急性大面积缺血性卒中有益。本研究旨在描述治疗时间对大面积缺血性卒中患者接受EVT与药物治疗（MM）疗效的影响。
这是一项对急性前循环大血管闭塞伴大面积梗死核心患者进行血管内治疗的随机试验的事后分析。症状发作24小时内阿尔伯塔卒中项目早期计算机断层扫描评分3 - 5或缺血核心体积70 - 100 mL的患者接受EVT联合MM或MM治疗。将发病至预期动脉穿刺时间（OPT）作为分类变量（<6、6 - <12和12 - 24小时），采用二元逻辑回归分析，作为连续变量采用多变量分数多项式交互分析。主要疗效结局为90天时的良好结局（改良Rankin量表评分0 - 3）。安全性结局包括任何颅内出血（ICH）、症状性ICH和死亡率。
在451例患者中（中位年龄68岁；61.4%为男性；中位OPT 487分钟[四分位间距328 - 802]），226例患者接受EVT，225例患者接受MM。在OPT为6小时内（44.4%对29.9%，调整优势比[aOR] 2.78，95% CI 1.22 - 6.32）和6 - 12小时内（45.7%对29.6%，aOR 2.39 [95% CI 1.21 - 4.71]），EVT组良好结局发生率高于MM组，但在OPT超过12小时时并非如此（51.6%对41.4%，aOR 2.05 [95% CI 0.88 - 4.77]）。在OPT为13小时22分钟后，这种益处变得不显著。在3个OPT时间段内，EVT和MM组的症状性ICH和死亡率相似，尽管任何ICH的发生率有所增加。然而，未发现交互作用（所有交互作用>0.10）。
这些发现强化了与单独MM相比，在症状发作后13小时22分钟内启动EVT对大面积缺血性卒中患者的益处，但对于发病超过13小时22分钟的患者不应拒绝使用EVT。需要对更大样本量进行汇总分析。
ClinicalTrials.gov；NCT04551664。
本研究提供了II类证据，表明EVT与最后一次已知健康状态后24小时内急性大面积缺血性卒中功能结局改善相关，且无时间交互作用。
