Outcomes associated to the time to treatment with intravenous tenecteplase for acute ischaemic stroke: subgroup analysis of the TRACE-2 randomised controlled clinical trial

作者：Shuya Li, Runqi Wangqin, Yuesong Pan, Aoming Jin, Hao Li, Lee H. Schwamm, Marc Fisher, Bruce Campbell, Mark Parsons, Ziran Wang, Hongguo Dai, Deyang Li, Runhui Li, Junhai Wang, David Wang, Yilong Wang, Yilong Wang, Xingquan Zhao, Zixiao Li, Huaguang Zheng, Yunyun Xiong, Xia Meng, Yongjun Wang, Yongjun Wang · 发表于：Stroke and Vascular Neurology · 年份：2024 · DOI：10.1136/svn-2023-002694 · 被引用次数：20 · 研究领域：Acute Ischemic Stroke Management、S100 Proteins and Annexins、Intracerebral and Subarachnoid Hemorrhage Research

BACKGROUND: The benefit of intravenous alteplase in acute ischaemic stroke (AIS) is time-dependent. Tenecteplase is non-inferior to alteplase among patients with AIS. We aimed to delineate the association of the stroke onset to treatment time (OTT) with tenecteplase compared with alteplase on therapeutic benefit and clinical risks. METHODS: This is a post hoc analysis of the Tenecteplase Reperfusion therapy in Acute ischaemic Cerebrovascular Events-2 an open-label, randomised, controlled, non-inferior trial. A total of 1430 AIS within 4.5 hours onset at 53 sites in China from 12 June 2021 to 29 May 2022 were randomly assigned (1:1) to receive either tenecteplase 0.25 mg/kg or alteplase 0.9 mg/kg. The primary efficacy outcome was the proportion of participants with a modified Rankin Scale score of 0-1 at 90 days. A post hoc subgroup analysis was conducted with the OTT divided into three intervals (0-90 min, 91-180 min and 181-270 min). The primary safety outcome was symptomatic intracranial haemorrhage within 36 hours post-thrombolytic treatment. RESULTS: Treatment was initiated within 270 min of stroke onset in 1412 patients who were randomly allocated to either tenecteplase (n=707) or alteplase (n=705). The OR of primary efficacy outcome was similar as OTT increased (p=0.84). Adjusted odds of an excellent functional outcome were 0.99 (95% CI 0.37 to 2.67) for 0-90 min, 1.23 (95% CI 0.88 to 1.71) for 91-180 min and 1.21 (95% CI 0.88 to 1.65) for 181-270 min. All were in favou...