Kaveeta Chitapa, Alhabli Ibrahim, Bala Fouzi, Horn MacKenzie, Benali Faysal, Coutts Shelagh B, Zafar Atif, Bereznyakova Olena, Khaw Alexander, Khosravani Houman, Hunter Gary, Tkach Aleksander, Dowlatshahi Dar, Catanese Luciana, Bogiatzi Chrysi, Appireddy Ramana, Buck Brian H, Swartz Richard H, Sajobi Tolulope T, Almekhlafi Mohammed, Demchuk Andrew M, Ganesh Aravind, Menon Bijoy, Singh Nishita
Department of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Division of Neurology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Int J Stroke. 2025 Jan;20(1):64-74. doi: 10.1177/17474930241273561. Epub 2024 Sep 11.
Early ischemic changes on baseline imaging are commonly evaluated for acute stroke decision-making and prognostication.
We assess the association of early ischemic changes on clinical outcomes and whether it differs between intravenous tenecteplase and Alteplase.
Data are from the phase 3, Alteplase compared to Tenecteplase (AcT) trial. Subjects with anterior circulation stroke were included. Early ischemic changes were assessed using the Alberta Stroke Program Early CT score (ASPECTS). Efficacy outcomes included modified Rankin scale (mRS) 0-1, mRS 0-2, and ordinal mRS at 90 days. Safety outcomes included 24-h symptomatic intracerebral hemorrhage (sICH), any hemorrhage on follow-up scan, and 90-day mortality rate. Mixed-effects logistic regression was used to assess the association of ASPECTS (continuous and categorical (0-4 vs 5-7 vs 8-10)) with outcomes and if these associations were modified by thrombolytic type after adjusting for age, sex, and baseline stroke severity.
Of the 1577 patients in the trial, 901 patients (56.3%; median age 75 years (IQR 65-84), 50.8% females, median National Institute of Health Stroke Scale (NIHSS) 14 (IQR 17-19)) with anterior circulation stroke were included. mRS 0-1 at 90 days was achieved in 1/14 (0.3%), 43/160 (14.7%), and 252/726 (85.1%) in the ASPECTS 0-4, 5-7, and 8-10 groups respectively. Every one-point decrease in ASPECTS was associated with 2.7% and 1.9% decrease in chances of mRS 0-1 and mRS 0-2 at 90 days, respectively, and 1.9% chances of increase in mortality at 90 days. Subgroup analysis in endovascular thrombectomy (EVT)-treated population showed similar results. Thrombolytic type did not modify this association between ASPECTS and 90-day mRS 0-1 (P-interaction 0.75). There was no significant interaction by thrombolytic type with any other outcomes.
Similar to prior studies, we found that every one-point decrease in ASPECTS was associated with poorer clinical and safety outcomes. This effect did not differ between alteplase and tenecteplase.
Data shall made available on reasonable request from the PI (BMM).
基线影像学上的早期缺血性改变常用于急性卒中的决策制定和预后评估。
我们评估早期缺血性改变与临床结局之间的关联,以及这种关联在静脉注射替奈普酶和阿替普酶之间是否存在差异。
数据来自3期阿替普酶与替奈普酶对比试验(AcT试验)。纳入前循环卒中患者。使用阿尔伯塔卒中项目早期CT评分(ASPECTS)评估早期缺血性改变。疗效结局包括90天时改良Rankin量表(mRS)评分为0 - 1、mRS评分为0 - 2以及mRS序数评分。安全性结局包括24小时症状性颅内出血(sICH)、随访扫描时的任何出血以及90天死亡率。在调整年龄、性别和基线卒中严重程度后,采用混合效应逻辑回归评估ASPECTS(连续变量和分类变量(0 - 4 vs 5 - 7 vs 8 - 10))与结局之间的关联,以及这些关联是否因溶栓类型而改变。
在该试验的1577例患者中,纳入了901例(56.3%;中位年龄75岁(四分位间距65 - 84岁),女性占50.8%,中位美国国立卫生研究院卒中量表(NIHSS)评分为14分(四分位间距17 - 19分))前循环卒中患者。ASPECTS评分为0 - 4、5 - 7和8 - 10组在90天时mRS评分为0 - 1的比例分别为1/14(0.3%)、43/160(14.7%)和252/726(85.1%)。ASPECTS评分每降低1分,90天时mRS评分为0 - 1和mRS评分为0 - 2的概率分别降低2.7%和1.9%,90天死亡率增加1.9%。血管内血栓切除术(EVT)治疗人群的亚组分析显示了相似的结果。溶栓类型并未改变ASPECTS与90天mRS评分为0 - 1之间的这种关联(交互P值为0.75)。溶栓类型与任何其他结局之间均无显著交互作用。
与先前研究相似,我们发现ASPECTS评分每降低1分与较差的临床和安全性结局相关。这种效应在阿替普酶和替奈普酶之间没有差异。
数据将在主要研究者(BMM)合理请求时提供。