Tenecteplase versus standard medical treatment for basilar artery occlusion within 24 h (TRACE-5): a multicentre, prospective, randomised, open-label, blinded-endpoint, superiority, phase 3 trial
Xiong Y, Et al. Lancet. 2026 Feb 21;407(10530):763-772. doi: 10.1016/S0140-6736(25)02633-9.
Editorial:
Intravenous tenecteplase for acute ischaemic stroke within 24 h due to basilar artery occlusion
Tsivgoulis G, et al. Lancet. 2026 Feb 21;407(10530):734-735. doi: 10.1016/S0140-6736(26)00139-X.
Methodology: 4/5
Usefulness: 3/5
Question and Methods: TRACE-5 randomised 452 patients with confirmed basilar artery occlusion (BAO) to IV tenecteplase (TNK) versus standard care within 24 hours, across 66 Chinese stroke centres.
Findings: Tenecteplase improved excellent functional outcome (mRS 0–1) at 90 days: 38% vs. 29% (NNT ≈ 11), with no increase in symptomatic hemorrhage or mortality.
Limitations: Single-ethnicity Chinese population, biosimilar TNK formulation only available in China, no perfusion imaging, and significant secondary endpoints did not reach statistical significance.
Interpretation: TRACE-5 supports considering IV TNK within 24 hours for confirmed BAO, particularly for rural/community emergency physicians managing patients before transfer to a stroke centre.
