Implementation of tenecteplase for acute ischemic stroke: workflow and safety in routine care including off-label use
- 1Department of Neurology, University Hospital Erlangen
- 2Department of Neuroradiology, University Hospital Erlangen
Abstract
Introduction: Tenecteplase is increasingly adopted as an alternative to alteplase for intravenous thrombolysis in acute ischemic stroke. However, real-world data describing complete institutional transitions, particularly in extended treatment windows and off-label clinical scenarios, remain limited.
Methods: We conducted a retrospective cohort study of consecutive patients treated with intravenous thrombolysis during the 12 months before and after a complete institutional transition from alteplase to tenecteplase (June 2023–May 2025). Primary endpoints were in-hospital workflow metrics (door-to-needle, door-to-imaging, imaging-to-needle, door-to-groin, and door-to-recanalization times). Safety outcomes included any intracranial hemorrhage and symptomatic intracranial hemorrhage according to the SITS-MOST definition. Outcomes were analyzed in the overall cohort, in patients treated beyond 4.5 h after symptom onset, and in patients receiving oral anticoagulation. Multivariable-adjusted and propensity score–based analyses, including augmented inverse probability of treatment weighting, were applied to account for baseline differences.
Results: Among 591 thrombolyzed patients (rt-PA n = 278; TNK n = 313), 31% were treated beyond 4.5 h and 14% under oral anticoagulation. Tenecteplase was associated with significantly shorter door-to-needle times (31 vs. 35 min; p = 0.004), primarily driven by reduced imaging-to-needle intervals (13 vs. 16 min; p = 0.004). Door-to-groin times were numerically shorter with tenecteplase but did not differ significantly (70 vs. 76 min; p = 0.07). Rates of any intracranial hemorrhage (8% vs. 7%; p = 0.61) and symptomatic intracranial hemorrhage (3% vs. 1%; p = 0.34) were comparable. Similar safety findings were observed in patients treated beyond 4.5 h after symptom onset and in those receiving oral anticoagulation, with consistent results across multivariable-adjusted and propensity score–based analyses.
Conclusion: Institutional transition to tenecteplase was associated with improved in-hospital workflow without evidence of increased hemorrhagic complications. These findings support the feasibility of implementing tenecteplase as the standard thrombolytic agent in routine comprehensive stroke center practice, including in extended treatment windows and selected off-label clinical scenarios.
Related
- The comparison of short-term outcome between tenecteplase and alteplase in minor acute ischemic stroke based on neutrophil-to-lymphocyte ratio stratification
- Tenecteplase for Acute Ischemic Stroke: From Molecular Bioengineering to Phase III Pivotal Trials.
- Low-Dose Tenecteplase for Acute Ischemic Stroke Treatment in Aging Patients DATE-AGING Trial: Rationale and Design
- Efficacy and Safety of Tenecteplase versus Alteplase in Acute Ischemic Stroke: A Systematic Review and Meta-Analysis
- Early prediction of 3-month functional outcome after acute ischemic stroke: an explainable model based on routine clinical data
BibTeX
@article{sekita2026implementation,
title = {{Implementation of tenecteplase for acute ischemic stroke: workflow and safety in routine care including off-label use}},
author = {Alexander Sekita and Kosmas Macha and Matthias C. Borutta and Maximilian I. Sprügel and Ludwig Singer and Tobias Engelhorn and Lena Mers and Anna Bogdanova and Stefan Schwab and Stefan T. Gerner},
journal = {Frontiers in Neurology},
year = {2026},
month = oct,
doi = {10.3389/fneur.2026.1882561},
url = {https://www.frontiersin.org/articles/10.3389/fneur.2026.1882561/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Implementation of tenecteplase for acute ischemic stroke: workflow and safety in routine care including off-label use
AU - Alexander Sekita
AU - Kosmas Macha
AU - Matthias C. Borutta
AU - Maximilian I. Sprügel
AU - Ludwig Singer
AU - Tobias Engelhorn
AU - Lena Mers
AU - Anna Bogdanova
AU - Stefan Schwab
AU - Stefan T. Gerner
PY - 2026
DA - 2026/10/28
JO - Frontiers in Neurology
DO - 10.3389/fneur.2026.1882561
UR - https://www.frontiersin.org/articles/10.3389/fneur.2026.1882561/full
AB - Introduction: Tenecteplase is increasingly adopted as an alternative to alteplase for intravenous thrombolysis in acute ischemic stroke. However, real-world data describing complete institutional transitions, particularly in extended treatment windows and off-label clinical scenarios, remain limited. Methods: We conducted a retrospective cohort study of consecutive patients treated with intravenous thrombolysis during the 12 months before and after a complete institutional transition from alteplase to tenecteplase (June 2023–May 2025). Primary endpoints were in-hospital workflow metrics (door-to-needle, door-to-imaging, imaging-to-needle, door-to-groin, and door-to-recanalization times). Safety outcomes included any intracranial hemorrhage and symptomatic intracranial hemorrhage according to the SITS-MOST definition. Outcomes were analyzed in the overall cohort, in patients treated beyond 4.5 h after symptom onset, and in patients receiving oral anticoagulation. Multivariable-adjusted and propensity score–based analyses, including augmented inverse probability of treatment weighting, were applied to account for baseline differences. Results: Among 591 thrombolyzed patients (rt-PA n = 278; TNK n = 313), 31% were treated beyond 4.5 h and 14% under oral anticoagulation. Tenecteplase was associated with significantly shorter door-to-needle times (31 vs. 35 min; p = 0.004), primarily driven by reduced imaging-to-needle intervals (13 vs. 16 min; p = 0.004). Door-to-groin times were numerically shorter with tenecteplase but did not differ significantly (70 vs. 76 min; p = 0.07). Rates of any intracranial hemorrhage (8% vs. 7%; p = 0.61) and symptomatic intracranial hemorrhage (3% vs. 1%; p = 0.34) were comparable. Similar safety findings were observed in patients treated beyond 4.5 h after symptom onset and in those receiving oral anticoagulation, with consistent results across multivariable-adjusted and propensity score–based analyses. Conclusion: Institutional transition to tenecteplase was associated with improved in-hospital workflow without evidence of increased hemorrhagic complications. These findings support the feasibility of implementing tenecteplase as the standard thrombolytic agent in routine comprehensive stroke center practice, including in extended treatment windows and selected off-label clinical scenarios.
SN - 1664-2295
ER -