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Current guideline recommendations

European Stroke Organisation (ESO) expedited recommendation on tenecteplase for acute ischaemic stroke (AIS)

Following the publication of several randomized controlled trials comparing tenecteplase with alteplase for intravenous thrombolysis (IVT) in patients with AIS, an expedited recommendation process was initiated by ESO following the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework.1 If insufficient evidence was available to provide recommendations, expert consensus statements were provided regarding the use of intravenous tenecteplase in patients with AIS eligible for IVT. The expedited recommendations for tenecteplase update the 2021 ESO Guidelines on IVT and the 2019 ESO-ESMINT Guidelines on mechanical thrombectomy.2,3

Evidence-based recommendations for patients eligible for IVT with AIS of duration within 4.5 hours include:

  • In light of safety and efficacy data, tenecteplase 0.25 mg/kg can be used as an alternative to alteplase 0.9 mg/kg.

  • In a mobile stroke unit, tenecteplase 0.25 mg/kg is suggested over alteplase 0.9 mg/kg to increase the rate of early reperfusion and shorten the time from imaging to treatment initiation.

  • In patients with large vessel occlusion (LVO), tenecteplase 0.25 mg/kg is recommended over alteplase 0.9 mg/kg (note: IVT should not delay mechanical thrombectomy).

Expert consensus statements for patients eligible for IVT with AIS of duration within 4.5 hours include: 

  • Tenecteplase 0.25 mg/kg may be favoured over alteplase 0.9 mg/kg in light of safety and efficacy data and because tenecteplase can be administered with a single bolus rather than a 1‑hr infusion. 

  • In patients with LVO, tenecteplase 0.25 mg/kg is recommended over alteplase 0.9 mg/kg (note: IVT should not delay mechanical thrombectomy, and the Expert Consensus Statement suggests IVT with tenecteplase 0.25 mg/kg over skipping IVT). 

  • For patients with LVO admitted to a centre without mechanical thrombectomy capability, tenecteplase is suggested, followed by rapid transfer to a thrombectomy-capable centre.

Considering these recommendations and the EMA and FDA approval of tenecteplase (in January 20244 and February 20255 respectively), tenecteplase is expected to become the new standard of care for systemic thrombolysis in patients with acute ischaemic stroke.6

An educational slide-kit on the topic of Guidelines for early management of Acute Ischaemic Stroke is provided in Medical education resources | Slide-kits

References

  1. Alamowitch S, et al. European Stroke Organisation (ESO) expedited recommendation on tenecteplase for acute ischaemic stroke. Eur Stroke J 2023; 8(1): 8-54.

  2. Berge E, et al. European Stroke Organisation (ESO) guidelines on intravenous thrombolysis for acute ischaemic stroke. Eur Stroke J 2021; 6: I–LXII.

  3. Turc G, et al. European Stroke Organisation - European Society for minimally Invasive Neurological Therapy expedited recommendation on indication for intravenous thrombolysis before mechanical thrombectomy in patients with acute ischaemic stroke and anterior circulation large vessel occlusion. Eur Stroke J 2022; 7: I–XXVI.

  4. European Summary of Product Characteristics. Boehringer Ingelheim International GmbH. January 2024. Metalyse | European Medicines Agency (europa.eu)

  5. Highlights of Prescribing Information for TNKase®. February 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/103909s5197lbl.pdf

  6. A new standard for thrombolysis in acute ischaemic stroke. Palaiodimou et al. Lancet Neurology 2024; 23(11): 1064-1065

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