Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
JAMA Neurol. 2024 Jan 1;81(1):30-38. doi: 10.1001/jamaneurol.2023.4430.
Endovascular therapy (EVT) demonstrated better outcomes compared with medical management in recent randomized clinical trials (RCTs) of patients with large infarct.
To compare outcomes of EVT vs medical management across different strata of the Alberta Stroke Program Early Computed Tomography Score (ASPECTS) and infarct core volume in patients with large infarct.
DESIGN, SETTING, AND PARTICIPANTS: This prespecified secondary analysis of subgroups of the Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients With a Large Infarct Core (ANGEL-ASPECT) RCT included patients from 46 stroke centers across China between October 2, 2020, and May 18, 2022. Participants were enrolled within 24 hours of symptom onset and had ASPECTS of 3 to 5 or 0 to 2 and infarct core volume of 70 to 100 mL. Patients were divided into 3 groups: ASPECTS of 3 to 5 with infarct core volume less than 70 mL, ASPECTS of 3 to 5 with infarct core volume of 70 mL or greater, and ASPECTS of 0 to 2.
Endovascular therapy or medical management.
The primary outcome was the ordinal 90-day modified Rankin Scale (mRS) score.
There were 455 patients in the trial; median age was 68 years (IQR, 60-73 years), and 279 (61.3%) were male. The treatment effect did not vary significantly across the 3 baseline imaging subgroups (P = .95 for interaction). The generalized odds ratio for the shift in the 90-day mRS distribution toward better outcomes with EVT vs medical management was 1.40 (95% CI, 1.06-1.85; P = .01) in patients with ASPECTS of 3 to 5 and infarct core volume less than 70 mL, 1.22 (95% CI, 0.81-1.83; P = .23) in patients with ASPECTS of 3 to 5 and infarct core volume of 70 mL or greater, and 1.59 (95% CI, 0.89-2.86; P = .09) in patients with ASPECTS of 0 to 2.
In this study, no significant interaction was found between baseline imaging status and the benefit of EVT compared with medical management in patients with large infarct core volume. However, estimates within subgroups were underpowered. A pooled analysis of large core trials stratified by ASPECTS and infarct core volume strata is warranted.
ClinicalTrials.gov Identifier: NCT04551664.
最近的随机临床试验（RCT）表明，对于大梗死患者，血管内治疗（EVT）的结果优于药物治疗。
比较大梗死患者不同 Alberta 卒中项目早期计算机断层扫描评分（ASPECTS）和梗死核心体积分层中 EVT 与药物治疗的结果。
设计、地点和参与者：本 ANGEL-ASPECT RCT 亚组的预设二次分析包括来自中国 46 家卒中中心的患者，入组时间为 2020 年 10 月 2 日至 2022 年 5 月 18 日。患者在症状出现后 24 小时内入组，ASPECTS 评分为 3 至 5 或 0 至 2，梗死核心体积为 70 至 100ml。患者分为 3 组：ASPECTS 评分为 3 至 5 且梗死核心体积小于 70ml，ASPECTS 评分为 3 至 5 且梗死核心体积为 70ml 或更大，以及 ASPECTS 评分为 0 至 2。
血管内治疗或药物治疗。
主要结局是 90 天改良 Rankin 量表（mRS）评分的等级。
该试验共纳入 455 例患者，中位年龄为 68 岁（IQR，60-73 岁），279 例（61.3%）为男性。在 3 个基线影像学亚组中，治疗效果没有显著差异（交互 P 值=0.95）。在 ASPECTS 评分为 3 至 5 且梗死核心体积小于 70ml 的患者中，与药物治疗相比，EVT 改善 90 天 mRS 分布的总体优势比为 1.40（95%CI，1.06-1.85；P=0.01），ASPECTS 评分为 3 至 5 且梗死核心体积为 70ml 或更大的患者为 1.22（95%CI，0.81-1.83；P=0.23），ASPECTS 评分为 0 至 2 的患者为 1.59（95%CI，0.89-2.86；P=0.09）。
在这项研究中，没有发现基线影像学状态与 EVT 相对于药物治疗在大梗死核心体积患者中的获益之间存在显著的交互作用。然而，亚组内的估计值效能不足。需要对大核心试验进行基于 ASPECTS 和梗死核心体积分层的汇总分析。
ClinicalTrials.gov 标识符：NCT04551664。
