Intravenous tenecteplase for acute ischaemic stroke within 24 h due to basilar artery occlusion.

# Intravenous tenecteplase for acute ischaemic stroke within 24 h due to basilar artery occlusion *The Lancet 2026* Comment Intravenous tenecteplase for acute ischaemic stroke within 24 h due to basilar artery occlusion Basilar artery occlusion is a devastating condition with in the ordinal (shift) analysis of mRS scores and dismal prognosis and constitutes the most severe with higher rates of substantial reperfusion at initial presentation of acute ischaemic stroke due to large- angiography. No significant benefit of tenecteplase was vessel occlusion.1 Randomised evidence on the safety observed in the secondary endpoints of early neurological and efficacy of intravenous thrombolysis in this stroke improvement within 72 h, good functional outcome subtype is scarce, especially outside the conventional (mRS scores of 0–2), and independent ambulation 0–4·5 h window.1,2 Tenecteplase is a third-generation (mRS scores of 0–3) at 3 months. With regard to safety tissue plasminogen activator with higher fibrin specificity outcomes, the incidence of symptomatic intracranial Published Online and longer half-life than alteplase.3 Accruing randomised haemorrhage, parenchymal haematoma, asymptomatic February 5, 2026 and observational evidence supports the superiority of intracranial haemorrhage, and 3-month mortality https://doi.org/10.1016/ S0140-6736(26)00139-X tenecteplase over alteplase in patients who have had an were similar in the two treatment groups. Predefined See Articles page 763 acute ischaemic stroke, particularly those with large-vessel subgroup analyses suggested consistent treatment occlusion, in improving 3-month functional outcome effect regardless of age, stroke severity, underlying assessed by the modified Rankin scale (mRS) score.3–8 cause of stroke, baseline imaging (CT vs MRI), use of Intravenous thrombolysis with tenecteplase has also been alteplase in the control group, intention for endovascular shown to be superior to no intravenous thrombolysis for thrombectomy, and multiple other potential treatment anterior circulation large-vessel occlusion in patients with effect modifiers. an acute ischaemic stroke not receiving endovascular Xiong and colleagues should be commended in thrombectomy in the extended time window of 4·5–24 h.9 conducting swiftly and efficiently a phase 3 pragmatic In The Lancet, Yunyun Xiong and colleagues trial that underscores the efficacy and safety of single- report the results of a multicentre, prospective, bolus tenecteplase administration in patients with basilar randomised, open-label, blinded-endpoint, superiority, artery occlusion who were selected without advanced phase 3 trial, TRACE-5.10 This trial was conducted in neuroimaging in both settings with endovascular China and compared intravenous thrombolysis with thrombectomy capability and with restricted tenecteplase versus standard medical treatment within capability. Nevertheless, there are certain limitations 24 h of onset of an acute ischaemic stroke in patients with that should be taken into account when interpreting basilar artery occlusion. Advanced neuroimaging was the results of TRACE-5. First, only about half of all not requested for patient selection. In both treatment enrolled patients received endovascular thrombectomy groups, the use of endovascular thrombectomy was (112 [51%] of 221 patients in the tenecteplase group left at the discretion of the treating physician. Patients and 125 [48%] of 231 patients in the standard medical randomly assigned to standard medical treatment could treatment group), which is the current standard of care receive intravenous thrombolysis with alteplase within in comprehensive stroke centres offering endovascular 4·5 h of symptom onset. A total of 452 patients (mean thrombectomy services 24 h a day. In addition, age 66·4 years [SD 11·2], 321 [71%] men, and median 66 (29%) of 230 patients with a baseline NIHSS score of National Institutes of Health Stroke Scale [NIHSS] 10 or higher (meeting international recommendations score of 12 [IQR 7–23]) were enrolled at 66 stroke centres for endovascular thrombectomy1) did not receive with endovascular thrombectomy capability. The trial was endovascular thrombectomy because of patient or positive with regard to the primary endpoint (proportion family refusal. One possible reason for this refusal might of patients with excellent functional outcome [mRS be the out-of-pocket cost given that patients or families scores of 0–1] or return to the pre-stroke mRS score currently need to cover a variable portion of endovascular [for patients with baseline mRS scores of 2–3] at thrombectomy expenses in the Chinese health system. 3 months after adjustment for prespecified confounders). Second, there was no evidence of a significant benefit Tenecteplase was also associated with reduced disability in post-hoc crude intention-to-treat and per-protocol 734 segamI ytteG aiv yoT eiluJ Comment analyses of all primary and secondary clinical endpoints. GTs has received unrestricted research or education grants (paid to institution) Third, the tenecteplase administered in the trial was a from Novartis, Genesis Pharma, Teva, Shore, Merck, Abbott, Allergan, Boehringer Ingelheim, Medtronic, Amicus, AbbVie, Ipsen, Bayer, Roche, Novalis, Bristol Myers biosimilar formulation that does not have marketing Squibb, Rare Disease Greece, Attica Rehab, and CSL Behring; received payment or authorisation in Europe, North America, and Australia. honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Novartis, Sanofi, Biogen, Genesis Pharma, Teva, Shire, Fourth, differences in underlying stroke risk factors and Merck, Bayer, Daichii-Sankyo, Allergan, Specifar, Boehringer Ingelheim, Medtronic, aetiologies across different ethnicities might limit the CSL Behring, Abbott, Taekda, AbbVie, Ipsen, ITF, Shionogi, Novasignal, Bristol Myers Squibb, AstraZeneca, Medison, Biomarin, Chiesi, UCB, Viatris, and Sandoz; generalisability of the study findings outside China. Fifth, and participated on data safety monitoring boards for DISTAL (NCT05029414), there was substantial variation in the recruitment rates ZODIAC (NCT03728738), and ADAPT II (NCT02281838). LP has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or across different centres, with 34 sites being unable to educational events from AstraZeneca, Biomarin, Boehringer Ingelheim, and Sanofi; recruit any patient and 14 sites enrolling a single patient, and support for attending meetings or travel from the European Stroke Organisation (Emerging Leader Programme). GTu has received consulting fees in contrast to a sole centre that enrolled 91 patients with from Neurologica, served on an advisory board for IA-Stroke, and received lecture basilar artery occlusion over 18 months. This variation fees from Guerbet France. might raise concerns regarding disparities in recruitment, *Georgios Tsivgoulis, Lina Palaiodimou, Guillaume Turc performance, and patient representativeness across tsivgoulisgiorg@yahoo.gr the different participating centres. Finally, TRACE-5 was Second Department of Neurology, National and Kapodistrian University of Athens, School of Medicine, “Attikon” University Hospital, Athens 12462, Greece not powered to demonstrate a significant benefit in the (GTs, LP); Department of Neurology, GHU Paris Psychiatrie et Neurosciences, subgroup of patients who were intended for endovascular Paris, France (GTu); Institute of Psychiatry and Neuroscience of Paris, Université Paris Cité, INSERM U1266, Paris, France (GTu) thrombectomy. However, there was no evidence of a 1 Strbian D, Tsivgoulis G, Ospel J, et al. European Stroke Organisation and differential treatment effect. The ongoing POST-ETERNAL European Society for Minimally Invasive Neurological Therapy guideline on acute management of basilar artery occlusion. Eur Stroke J 2024; 9: 835–84. trial (NCT05105633) and the planned individual patient 2 Berge E, Whiteley W, Audebert H, et al. European Stroke Organisation (ESO) data pooled analysis will shed more light on this question. guidelines on intravenous thrombolysis for acute ischaemic stroke. Eur Stroke J 2021; 6: I-LXII. In conclusion, this phase 3 trial provides evidence 3 Tsivgoulis G, Katsanos AH, Sandset EC, et al. Thrombolysis for acute ischaemic that intravenous thrombolysis with tenecteplase stroke: current status and future perspectives. Lancet Neurol 2023; 22: 418–29. 4 Alamowitch S, Turc G, Palaiodimou L, et al. European Stroke Organisation within 24 h from symptom onset is effective and safe (ESO) expedited recommendation on tenecteplase for acute ischaemic in patients with acute ischaemic stroke and basilar stroke. Eur Stroke J 2023; 8: 8–54. 5 Palaiodimou L, Katsanos AH, Turc G, et al. Tenecteplase vs alteplase in acute artery occulsion, particularly in the subgroup of ischemic stroke within 4.5 hours: a systematic review and meta-analysis of randomized trials. Neurology 2024; 103: e209903. patients not treated with endovascular thrombectomy. 6 Katsanos AH, Psychogios K, Turc G, et al. Off-label use of tenecteplase for The treatment effect of tenecteplase in basilar artery the treatment of acute ischemic stroke: a systematic review and meta- analysis. JAMA Netw Open 2022; 5: e224506. occlusion seemed to be analogous to the treatment 7 Gerschenfeld G, Turc G, Obadia M, et al. Functional outcome and effect of tenecteplase in anterior circulation large- hemorrhage rates after bridging therapy with tenecteplase or alteplase in patients with large ischemic core. Neurology 2024; 103: e209398. vessel occlusion,9 while patient selection was based 8 Rousseau JF, Weber JM, Alhanti B, et al. Short-term safety and effectiveness on a pragmatic approach without mandatory use of for tenecteplase and alteplase in acute ischemic stroke. JAMA Netw Open 2025; 8: e250548. advanced neuroimaging. Should the results of TRACE-5 9 Xiong Y, Campbell BCV, Schwamm LH, et al. Tenecteplase for ischemic stroke be independently confirmed in non-Asian populations at 4.5 to 24 hours without thrombectomy. N Engl J Med 2024; 391: 203–12. 10 Xiong Y, Alemseged F, Cao Z, et al. Tenecteplase versus standard medical harbouring different risk factors and diverse underlying treatment for basilar artery occlusion within 24 h (TRACE-5): a multicentre, prospective, randomised, open-label, blinded-endpoint, superiority, mechanisms of acute ischaemic stroke, they have the phase 3 trial. Lancet 2026; published online Feb 5. https://doi.org/10.1016/ potential to revise stroke guidelines worldwide. S0140-6736(25)02633-9. Testing early haemostatic therapy for acute intracerebral haemorrhage The clinical severity, narrow time window to reduce overcome by treatments for this serious condition. Published Online bleeding, and variable care pathways for patients In this issue of The Lancet, Joseph P Broderick and February 4, 2026 https://doi.org/10.1016/ with spontaneous (non-traumatic) intracerebral colleagues1 present the results of the FASTEST trial, S0140-6736(26)00146-7 haemorrhage (ICH) are enormous challenges to be a monumental effort to establish the safety and See Articles page 773 --- [PDF原文](https://sci-net.xyz/storage/7932541/2403710a532505cd11326e3400011406f654ea5a1a7fb5d874c617d448c35caf/Intravenous-tenecteplase-for-acute-ischaemic-stroke-within-24-h-due-to-basilar-artery-occlusion.pdf) DOI: 10.1016/S0140-6736(26)00139-X