• Wenjie Zi, Zhongming Qiu, Fengli Li, Hongfei Sang, Deping Wu, Weidong Luo, Shuai Liu, Junjie Yuan, Jiaxing Song, Zhonghua Shi, Wenguo Huang, Min Zhang, Wenhua Liu, Zhangbao Guo, Tao Qiu, Qiang Shi, Peiyang Zhou, Li Wang, Xinmin Fu, Shudong Liu, Shiquan Yang, Shuai Zhang, Zhiming Zhou, Xianjun Huang, Yan Wang, Jun Luo, Yongjie Bai, Youlin Wu, Guoyong Zeng, Yue Wan, Changming Wen, Hongbin Wen, Wentong Ling, Zhuo Chen, Miao Peng, Zhibing Ai, Fuqiang Guo, Huagang Li, Jing Guo, Haitao Guan, Zhiyi Wang, Yong Liu, Jie Pu, Zhen Wang, Hansheng Liu, Luming Chen, Jiacheng Huang, Guoqiang Yang, Zili Gong, Jie Shuai, Raul G Nogueira, Qingwu Yang, and DEVT Trial Investigators.
• Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Shapingba District, Chongqing, China.
• JAMA. 2021 Jan 19; 325 (3): 234-243.

ImportanceFor patients with large vessel occlusion strokes, it is unknown whether endovascular treatment alone compared with intravenous thrombolysis plus endovascular treatment (standard treatment) can achieve similar functional outcomes.ObjectiveTo investigate whether endovascular thrombectomy alone is noninferior to intravenous alteplase followed by endovascular thrombectomy for achieving functional independence at 90 days among patients with large vessel occlusion stroke.Design, Setting, And ParticipantsMulticenter, randomized, noninferiority trial conducted at 33 stroke centers in China. Patients (n = 234) were 18 years or older with proximal anterior circulation intracranial occlusion strokes within 4.5 hours from symptoms onset and eligible for intravenous thrombolysis. Enrollment took place from May 20, 2018, to May 2, 2020. Patients were enrolled and followed up for 90 days (final follow-up was July 22, 2020).InterventionsA total of 116 patients were randomized to the endovascular thrombectomy alone group and 118 patients to combined intravenous thrombolysis and endovascular thrombectomy group.Main Outcomes And MeasuresThe primary end point was the proportion of patients achieving functional independence at 90 days (defined as score 0-2 on the modified Rankin Scale; range, 0 [no symptoms] to 6 [death]). The noninferiority margin was -10%. Safety outcomes included the incidence of symptomatic intracerebral hemorrhage within 48 hours and 90-day mortality.ResultsThe trial was stopped early because of efficacy when 234 of a planned 970 patients had undergone randomization. All 234 patients who were randomized (mean age, 68 years; 102 women [43.6%]) completed the trial. At the 90-day follow-up, 63 patients (54.3%) in the endovascular thrombectomy alone group vs 55 (46.6%) in the combined treatment group achieved functional independence at the 90-day follow-up (difference, 7.7%, 1-sided 97.5% CI, -5.1% to ∞)P for noninferiority = .003). No significant between-group differences were detected in symptomatic intracerebral hemorrhage (6.1% vs 6.8%; difference, -0.8%; 95% CI, -7.1% to 5.6%) and 90-day mortality (17.2% vs 17.8%; difference, -0.5%; 95% CI, -10.3% to 9.2%).Conclusions And RelevanceAmong patients with ischemic stroke due to proximal anterior circulation occlusion within 4.5 hours from onset, endovascular treatment alone, compared with intravenous alteplase plus endovascular treatment, met the prespecified statistical threshold for noninferiority for the outcome of 90-day functional independence. These findings should be interpreted in the context of the clinical acceptability of the selected noninferiority threshold.Trial RegistrationChinese Clinical Trial Registry: ChiCTR-IOR-17013568.

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