Endovascular Therapy Versus Medical Management for Large Ischemic Infarct: 1-Year Outcomes of the ANGEL-ASPECT Trial
Xiaochuan Huo, Dapeng Sun, Thanh N. Nguyen, Gaoting Ma, Yuesong Pan, Xin Tong, Guangxiong Yuan, Hongxing Han, Wenhuo Chen, Ming Wei, Jiangang Zhang, Zhiming Zhou, Xiaoxi Yao, Weigen Song, Xueli Cai, Guangxian Nan, Di Li, Alvin Yi-Chou Wang, Wentong Ling, Chuwei Cai, Changming Wen, En Wang, Liyong Zhang, Changchun Jiang, Geng Liao, Xiaohui Chen, Tianxiao Li, Shudong Liu, Jinglun Li, Yaxuan Sun, Na Xu, Zongen Gao, Dongsheng Ju, Cunfeng Song, Feng Zhou, Qing Shi, Jun Luo, Yan Liu, Zaiyu Guo, Hongbo Zheng, Linzhi Dai, Junfeng Zhao, Xiaokun Geng, Yufeng Tang, Congguo Yin, Hua Yang, Xuelei Zhang, Shuo Li, Mohamad Abdalkader, Feng Gao, Ning Ma, Dapeng Mo, Zeguang Ren, Liping Liu, Yongjun Wang, Zhongrong Miao, on behalf of the ANGEL-ASPECT Investigators
Abstract
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: =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.