{ "abstract": "Abstract Objective To assess the efficacy and safety of edaravone dexborneol, a multitarget brain cytoprotectant composed of antioxidant and anti-inflammatory ingredients, in improving functional outcomes among patients with acute ischaemic stroke undergoing endovascular thrombectomy.Design Multicentre, double blind, randomised, placebo controlled trial.Setting 106 hospitals in China between March 2022 and May 2023.Participants 1362 patients with clinically diagnosed acute ischaemic stroke within 24 hours of symptom onset, aged 18-80 years, with a National Institutes of Health Stroke Scale (NIHSS) score of 6-25 and an Alberta Stroke Program Early Computed Tomography Score (ASPECTS) of 6-10, confirmed large vessel occlusion in the anterior circulation, and planned endovascular thrombectomy.Interventions Patients were randomly allocated in a 1:1 ratio to receive edaravone dexborneol 37.5 mg (edaravone, 30 mg; (+)−dexborneol, 7.5 mg; 690 patients) or placebo (672 patients) before endovascular thrombectomy and continued the regimen twice daily for a consecutive period of 10-14 days.Main outcome measures Functional independence at 90 days, defined as a modified Rankin Scale score (range 0 (no symptoms) to 6 (death)) of 0-2, and serious adverse events.Results One patient from each group was lost to follow-up at 90 days. Of the 1360 patients included in the intention-to-treat analysis, 379 (55.0%) of 689 patients in the edaravone dexborneol group and 333 (49.6%) of 671 patients in the placebo group achieved functional independence on day 90 (risk ratio 1.11, 95% confidence interval (CI) 1.00 to 1.23; P=0.05; risk difference 5.4%, 95% CI 0.1% to 10.7%). Patients with mismatch at admission (defined as NIHSS score ≥10 and ASPECTS ≥9 or NIHSS score ≥20 and ≥7) were more likely to achieve functional independence in the subgroup analysis (55.5% (178/321) versus 42.9% (134/312); risk ratio 1.29, 1.10 to 1.52; risk difference 13.0%, 5.6% to 20.3%; P for interaction=0.003). The rates of serious adverse events were similar in the two groups (27.2% (188/690) versus 25.7% (173/672); risk ratio 1.06, 0.89 to 1.26; risk difference 1.5%, −3.2% to 6.2%: P=0.53).Conclusions Among patients with acute ischaemic stroke within 24 hours of symptom onset who underwent endovascular thrombectomy, those treated with edaravone dexborneol, compared with placebo, were more likely to achieve functional independence at 90 days without increased safety concerns. This effect seemed to be primarily driven by the subgroup with mismatch present at admission, suggesting that dedicated trials in this population may be warranted.Trial registration ClinicalTrials.gov NCT05249920.", "authors": [ { "affiliations": [ "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China", "China National Clinical Research Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Chunjuan Wang" }, { "affiliations": [ "China National Clinical Research Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Hongqiu Gu" }, { "affiliations": [ "Department of Cerebrovascular Disease, Neurological Disease Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China" ], "name": "Xiaochuan Huo" }, { "affiliations": [ "China National Clinical Research Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Baoshi Yuan" }, { "affiliations": [ "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Shuo Li" }, { "affiliations": [ "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China", "China National Clinical Research Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Jie Xu" }, { "affiliations": [ "China National Clinical Research Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Yong Jiang" }, { "affiliations": [ "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China", "China National Clinical Research Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Jing Jing" }, { "affiliations": [ "Department of Neurology, The First People's Hospital of Chen Zhou City, Chenzhou, China" ], "name": "Xiaoxi Yao" }, { "affiliations": [ "Department of Neurology, The People's Hospital of Huazhou, Huazhou, China" ], "name": "Zhiliang Li" }, { "affiliations": [ "Department of Neurology, The Second Affiliated Hospital of Hainan Medical University, Haikou, China" ], "name": "Faqing Long" }, { "affiliations": [ "Department of Neurology, Suzhou Hospital of Anhui Medical University, Suzhou, China" ], "name": "Zhengfei Ma" }, { "affiliations": [ "Department of Neurology, Liaocheng Brain Hospital, Liaocheng, China" ], "name": "Xianbo Zhuang" }, { "affiliations": [ "Department of Neurology, Central Hospital of Jiamusi City, Heilongjiang Province, Jiamusi, China" ], "name": "Lihua Xu" }, { "affiliations": [ "Department of Neurology, The People's Hospital of Bozhou, Bozhou, China" ], "name": "Yu Jin" }, { "affiliations": [ "Department of Neurology, Maoming Hospital of Guangzhou University of Chinese Medicine, Maoming, China" ], "name": "Wenguo Huang" }, { "affiliations": [ "Department of Neurology, The First People's Hospital of Wenling, Wenling, China" ], "name": "Yongqiang Zhang" }, { "affiliations": [ "Department of Neurology, The First People's Hospital of Changde City, Changde, China" ], "name": "Jun Wen" }, { "affiliations": [ "China National Clinical Research Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Anxin Wang" }, { "affiliations": [ "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China", "China National Clinical Research Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Yuesong Pan" }, { "affiliations": [ "China National Clinical Research Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Wanxing Ye" }, { "affiliations": [ "China National Clinical Research Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Weiran Yu" }, { "affiliations": [ "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China", "China National Clinical Research Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Aichun Cheng" }, { "affiliations": [ "China National Clinical Research Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Meng Wang" }, { "affiliations": [ "Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China" ], "name": "Qiang Dong" }, { "affiliations": [ "Department of Neurology, The First Affiliated Hospital of Jinan University, Guangzhou, China" ], "name": "Anding Xu" }, { "affiliations": [ "Department of Neurology, The First Affiliated Hospital, Institute of Neuroscience, Fujian Medical University, Fuzhou, China" ], "name": "Ning Wang" }, { "affiliations": [ "Department of Neurology, the First Hospital of Jilin University, Changchun, China" ], "name": "Yi Yang" }, { "affiliations": [ "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China", "China National Clinical Research Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Xia Meng" }, { "affiliations": [ "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China", "China National Clinical Research Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Liping Liu" }, { "affiliations": [ "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China", "China National Clinical Research Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Xingquan Zhao" }, { "affiliations": [ "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Hao Li" }, { "affiliations": [ "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China", "China National Clinical Research Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Zhongrong Miao" }, { "affiliations": [ "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China", "China National Clinical Research Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China" ], "name": "Zixiao Li" }, { "affiliations": [ "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China", "China National Clinical Research Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China", "The Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China", "Research Unit of Artificial Intelligence in Cerebrovascular Disease, Chinese Academy of Medical Sciences, Beijing, China" ], "name": "Yongjun Wang" }, { "affiliations": [], "name": "on behalf of the TASTE-2 investigators" } ], "title": "Edaravone dexborneol versus placebo on functional outcomes in patients with acute ischaemic stroke undergoing endovascular thrombectomy (TASTE-2): randomised controlled trial", "uid": "ba7b4740-1c7e-54c9-8a8e-8c49864115e4" }