血管内治疗与药物治疗对大面积缺血性梗死的疗效：ANGEL-ASPECT试验的1年结果
Endovascular Therapy Versus Medical Management for Large Ischemic Infarct: 1-Year Outcomes of the ANGEL-ASPECT Trial.
作者信息
Huo Xiaochuan, Sun Dapeng, Nguyen Thanh N, Ma Gaoting, Pan Yuesong, Tong Xin, Yuan Guangxiong, Han Hongxing, Chen Wenhuo, Wei Ming, Zhang Jiangang, Zhou Zhiming, Yao Xiaoxi, Song Weigen, Cai Xueli, Nan Guangxian, Li Di, Wang Alvin Yi-Chou, Ling Wentong, Cai Chuwei, Wen Changming, Wang En, Zhang Liyong, Jiang Changchun, Liao Geng, Chen Xiaohui, Li Tianxiao, Liu Shudong, Li Jinglun, Sun Yaxuan, Xu Na, Gao Zong'en, Ju Dongsheng, Song Cunfeng, Zhou Feng, Shi Qing, Luo Jun, Liu Yan, Guo Zaiyu, Zheng Hongbo, Dai Linzhi, Zhao Junfeng, Geng Xiaokun, Tang Yufeng, Yin Congguo, Yang Hua, Zhang Xuelei, Li Shuo, Abdalkader Mohamad, Gao Feng, Ma Ning, Mo Dapeng, Ren Zeguang, Liu Liping, Wang Yongjun, Miao Zhongrong
机构信息
Cerebrovascular Disease Department, Neurological Disease Center, Beijing Anzhen Hospital (X.H., X.T., X.Z., S. Li), Capital Medical University, China.
Department of Neurology, Interventional Neuroradiology (D.S., Y.P., F.G., N.M., D.M., Z.M.), Beijing Tiantan Hospital, Capital Medical University, China.
出版信息
Stroke. 2025 Sep;56(9):2398-2407. doi: 10.1161/STROKEAHA.124.050086. Epub 2025 Aug 25.
BACKGROUND
Several trials have shown the benefit and safety of endovascular therapy (EVT) compared with medical management (MM) of patients with a large ischemic core in the 90-day follow-up. However, the 1-year outcome comparison between EVT and MM in Asian patients with a large ischemic core has not been investigated. Our aim was to evaluate the 1-year outcomes of patients in the ANGEL-ASPECT trial (Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core).
METHODS
In this phase 3, randomized, open-label, blinded end point assessment trial, patients with anterior circulation large vessel occlusion and an Alberta Stroke Program Early CT Score of 3 to 5 or an infarct core volume of 70 to 100 mL were enrolled across 46 hospitals in China. Patients were randomly assigned 1:1 to EVT or MM. The 90-day outcomes were previously reported. We report a prespecified analysis of the ANGEL-ASPECT trial, with 1-year functional outcome as the primary outcome in this study. The primary outcome was the shift of the modified Rankin Scale (mRS) score (range, 0-6, with a higher score reflecting greater disability) to better outcomes at 1-year. The secondary outcomes included functional independence (mRS score, 0-2), independent ambulation (mRS score, 0-3), and mortality. This trial is registered with https://www.clinicaltrials.gov (Unique identifier: NCT04551664).
RESULTS
One-year data were available for 425 of 455 (93%) patients for the primary outcome, with 214 patients in the EVT group and 211 in the MM group in the complete case analysis. The mean age was 66 years, and 38.1% were female. There was a greater likelihood of shift toward improved 1-year mRS distribution in the EVT compared with the MM group (generalized odds ratio, 1.25 [95% CI, 1.01-1.56]; =0.04). Functional independence and independent ambulation were higher in the EVT compared with MM groups (mRS score, 0-2: 30.4% [65/214] versus 17.1% [36/211]; relative risk, 1.87 [95% CI, 1.27-2.75]; mRS score, 0-3: 50.0% [107/214] versus 35.6% [75/211]; relative risk, 1.46 [95% CI, 1.15-1.85], respectively). The 1-year mortality rate was 31.3% (67/214) in the EVT group and 26.5% (56/211) in the MM group (relative risk, 1.12 [95% CI, 0.82-1.53]). In addition, no change was found in the rate of functional independence between 90 days and 1 year in the EVT group (29.4% [69/214] versus 30.4% [65/214], respectively); however, a gain in functional independence was observed in the MM group from 90 days to 1 year (10.9% [26/211] versus 17.1% [36/211]), narrowing the magnitude of EVT treatment effect from 18.5% at 90 days to 13.3% at 1 year.
CONCLUSIONS
In patients with large ischemic stroke from a proximal arterial occlusion presenting within 24 hours of onset, EVT reduced disability with durable 1-year benefit compared with MM.
REGISTRATION
URL: https://www.clinicaltrials.gov; Unique identifier: NCT04551664.
背景
多项试验表明，在90天的随访中，与药物治疗（MM）相比，血管内治疗（EVT）对大面积缺血核心患者有益且安全。然而，尚未对亚洲大面积缺血核心患者中EVT与MM的1年结局进行比较。我们的目的是评估ANGEL-ASPECT试验（急性前循环大血管闭塞伴大面积梗死核心患者的血管内治疗）中患者的1年结局。
方法
在这项3期、随机、开放标签、盲法终点评估试验中，中国46家医院招募了前循环大血管闭塞且阿尔伯塔卒中项目早期CT评分为3至5或梗死核心体积为70至100 mL的患者。患者按1:1随机分配至EVT组或MM组。90天结局已在之前报告。我们报告ANGEL-ASPECT试验的一项预先设定的分析，本研究以1年功能结局作为主要结局。主要结局是改良Rankin量表（mRS）评分（范围为0 - 6，评分越高表明残疾程度越高）在1年时向更好结局的转变。次要结局包括功能独立（mRS评分，0 - 2）、独立行走（mRS评分，0 - 3）和死亡率。本试验已在https://www.clinicaltrials.gov注册（唯一标识符：NCT04551664）。
结果
455例患者中有425例（93%）可获得1年数据用于主要结局分析，在完整病例分析中，EVT组有214例患者，MM组有211例患者。平均年龄为66岁，女性占38.1%。与MM组相比，EVT组1年mRS分布向改善方向转变的可能性更大（广义优势比，1.25 [95% CI，1.01 - 1.56]；P = 0.04）。与MM组相比，EVT组的功能独立和独立行走比例更高（mRS评分，0 - 2：30.4% [65/214] 对17.1% [36/211]；相对风险，1.87 [95% CI，1.27 - 2.75]；mRS评分，0 - 3：50.0% [107/214] 对35.6% [75/211]；相对风险，1.46 [95% CI，1.15 - 1.85]）。EVT组1年死亡率为31.3%（67/214），MM组为26.5%（56/211）（相对风险，1.12 [95% CI，0.82 - 1.53]）。此外，EVT组90天至1年的功能独立率无变化（分别为[69/214] 29.并与MM组相比，EVT组的功能独立和独立行走比例更高（mRS评分，0 - 2：30.4% [65/214] 对17.1% [36/211]；相对风险，1.87 [95% CI，1.27 - 2.75]；mRS评分，0 - 3：50.0% [107/214] 对35.6% [75/211]；相对风险，1.46 [95% CI，1.15 - 1.85]）。EVT组1年死亡率为31.3%（67/214），MM组为26.5%（56/211）（相对风险，1.12 [95% CI，0.82 - 1.53]）。此外，EVT组90天至1年的功能独立率无变化（分别为29.4% [69/214] 对30.4% [65/214]）；然而，MM组从90天到1年功能独立有所增加（10.9% [26/211] 对17.1% [36/211]），使EVT治疗效果从90天时相差18.5%缩小到1年时相差13.3%。
结论
对于发病24小时内出现的近端动脉闭塞所致大面积缺血性卒中患者，与MM相比，EVT可降低残疾程度并在1年时带来持久益处。
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