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

Shuya Li, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Runqi Wangqin, Department of Neurology, Duke University Medical Center, Durham, NC, USA.
Yuesong Pan, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Aoming Jin, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Hao Li, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Lee H. Schwamm, Department of Neurology and Comprehensive Stroke Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Marc Fisher, Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Bruce C. Campbell, Department of Medicine and Neurology, Melbourne Brain Centre at Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia.
Mark W. Parsons, Department of Neurology, Liverpool Hospital, University of New South Wales South Western Sydney Clinical School, Sydney, New South Wales, Australia.
Ziran Wang, Department of Neurology, Linyi People's Hospital, Linyi, Shandong, China.
Hongguo Dai, Department of Neurology, Linfen Central Hospital, Linfen, China.
Deyang Li, Department of Neurology, Tengzhou Central People's Hospital, Tengzhou, Shandong, China.
Runhui Li, Central Hospital Affiliated to Shenyang Medical College, Shenyang, China.
Junhai Wang, Department of Neurology, General Hospital of DaTong Coal Mine Group, Datong, Shanxi, China.
David Wang, Department of Neurology, Petznick Stroke Center, Barrow Neurological Institute, Phoenix, Arizona, USA.Follow
Yilong Wang, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Xingquan Zhao, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Zixiao Li, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Huaguang Zheng, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Yunyun Xiong, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Xia Meng, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Yongjun Wang, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China yongjunwang@ncrcnd.org.cn.

Document Type

Article

Abstract

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 favour of the tenecteplase group. Meta-analysis of 2949 patients yielded a pooled risk difference of 5.54 (95% CI -0.18 to 11.26; p=0.82) in favour of tenecteplase for more than 180 min and 1.77 (95% CI -2.66 to 6.20; p=0.58) for 0-180 min. CONCLUSIONS: In AIS patients who were treated with either tenecteplase or alteplase within 4.5 hours onset, there was no difference observed in the efficacy and safety between the two groups at the three different OTT time intervals.

Publication Date

1-31-2024

Publication Title

Stroke and vascular neurology

E-ISSN

2059-8696

PubMed ID

38296586

Digital Object Identifier (DOI)

10.1136/svn-2023-002694

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