Intravenous Tenecteplase before Thrombectomy in Stroke
Zhongming Qiu, Fengli Li, Hongfei Sang, Guangxiong Yuan, Dongjing Xie, Kai Zhou, Maohua Li, Zhaoyou Meng, Zhenyu Kong, Zhongfan Ruan, Chaoqun Li, Guangui Yang, Junxiong Wu, Long Chen, Bo Yang, Hai Hu, Yanling Li, Jun Luo, Zhonghua Shi, Xianjun Huang, Shunfu Jiang, Tingyu Yi, Guoyong Zeng, Jincheng Liu, Xiao‐Jun Luo, Shudong Liu, Mingze Chang, Youlin Wu, Yufeng Tang, Zhenxuan Tian, Zhizhong Yan, Haojin Zhao, Yuqi Peng, Hongguo Dai, Peiyang Zhou, Huagang Li, Wenhua Liu, Dengwen Song, Bo Lei, Zhongbin Xia, Xiaolin Tan, Maojun Zhao, Xinggang Feng, Lingyu Cai, Qi Li, Yuelu Wu, Bingwu Jiang, Yan Tian, Linyu Li, Ling Jiang, Xing Long, Feng You, Jian Tao, Jin Zhou, Derong Wu, Chong Zheng, Congguo Yin, Duolao Wang, Mengjie Lu, Gregory W. Albers, Raul G. Nogueira, Bruce Campbell, Thanh N. Nguyen, Jeffrey L. Saver, Wenjie Zi, Qingwu Yang
Abstract
BACKGROUND: The safety and efficacy of treatment with intravenous tenecteplase before endovascular thrombectomy in patients with acute ischemic stroke due to large-vessel occlusion remain uncertain. METHODS: In this open-label trial conducted in China, we randomly assigned patients with acute ischemic stroke due to large-vessel occlusion who had presented within 4.5 hours after onset and were eligible for thrombolysis to receive either intravenous tenecteplase followed by endovascular thrombectomy or endovascular thrombectomy alone. The primary outcome was functional independence (a score of 0 to 2 on the modified Rankin scale; range, 0 to 6, with higher scores indicating more severe disability) at 90 days. Secondary outcomes included successful reperfusion before and after thrombectomy. Safety outcomes included symptomatic intracranial hemorrhage within 48 hours and death within 90 days. RESULTS: A total of 278 patients were randomly assigned to the tenecteplase-thrombectomy group and 272 to the thrombectomy-alone group. Functional independence at 90 days was observed in 147 patients (52.9%) in the tenecteplase-thrombectomy group and in 120 patients (44.1%) in the thrombectomy-alone group (unadjusted risk ratio, 1.20; 95% confidence interval, 1.01 to 1.43; P = 0.04). A total of 6.1% of the patients in the tenecteplase-thrombectomy group and 1.1% of those in the thrombectomy-alone group had successful reperfusion before thrombectomy, and 91.4% and 94.1%, respectively, had successful reperfusion after thrombectomy. Symptomatic intracranial hemorrhage within 48 hours occurred in 8.5% of the patients in the tenecteplase-thrombectomy group and in 6.7% of those in the thrombectomy-alone group; mortality at 90 days was 22.3% and 19.9%, respectively. CONCLUSIONS: Among patients with acute ischemic stroke due to large-vessel occlusion who had presented within 4.5 hours after onset, the percentage of patients with functional independence at 90 days was higher with intravenous tenecteplase plus endovascular thrombectomy than with endovascular thrombectomy alone. (Funded by the Chongqing Science and Health Joint Medical Research Project and others; BRIDGE-TNK ClinicalTrials.gov number, NCT04733742.).