Endovascular Therapy Versus Medical Management for Large Ischemic Infarct: 1-Year Outcomes of the ANGEL-ASPECT Trial.
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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, ANGEL-ASPECT Investigators
Аннотация
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]; P=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.