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Intravenous Tenecteplase Prior to Endovascular Treatment for Ischemic Stroke at 4.5 to 24 Hours: The TNK-PLUS Randomized Clinical Trial.

作者:Yunyun Xiong, Feng-Yuan Che, Hao Wang, M. Hao, Thanh N. Nguyen, Marc Fisher, Aoming Jin, Zhixin Cao, Ziran Wang, Xiaoxi Yao, Gang-Hua Feng, Yue-Long Xu, Shi-chang Guo, Hao Qin, Xianjun Huang, Jianxin Xu, Zhongjun Chen, Jinglin Yuan, Wenshuai Li, Wei Hu, Xueyan Feng, Lixia Zong, Wanxing Ye, C. Duan, Li-Yuan Wang, Shuangzhe Wu, Bruce C. V. Campbell, Yongjun Wang · 发表于:Journal of the American Medical Association (JAMA) · 年份:2026 · DOI:10.1001/jama.2026.4292 · 被引用次数:5 · 研究领域:Medicine

Importance Whether intravenous tenecteplase prior to endovascular treatment (EVT) for ischemic stroke reduces disability in the late time window is unclear. Objective To investigate the adverse events and efficacy of tenecteplase prior to EVT in patients 4.5 to 24 hours after ischemic stroke onset due to proximal middle cerebral artery (MCA) occlusion. Design, Setting, and Participants Multicenter, phase 3, randomized, open-label, blinded end point, superiority trial conducted at 40 centers in China. Adult (≥18 years) patients with acute ischemic stroke 4.5 to 24 hours after last known to be well due to MCA-M1 or proximal M2 occlusion with salvageable brain tissue (ischemic core volume <70 mL, mismatch ratio ≥1.8, and mismatch volume ≥15 mL) identified on computed tomography-perfusion or magnetic resonance-perfusion-diffusion imaging were enrolled from January 25, 2024, through July 21, 2025, and followed up for 90 days. Final follow-up occurred on October 14, 2025. Interventions Eligible patients were randomly assigned in a 1:1 ratio to receive intravenous tenecteplase (0.25 mg/kg; maximum dose, 25 mg) before EVT (n = 199) or EVT alone (n = 192). Main Outcomes and Measures The primary outcome was functional independence, defined as a score of 0 to 2 on the modified Rankin Scale (range, 0-6, with higher scores indicating greater disability) at 90 days. Adverse events outcomes included symptomatic intracranial hemorrhage and death. Results All of the 391 patients enr...