Efficacy and Safety of Tenecteplase for Acute Ischemic Stroke Within an Extended Treatment Window: A Systematic Review, Meta-Analysis, and Trial Sequential Analysis of Randomized Controlled Trials

Authors

• Hesham Kelani, SUNY Downstate Health Sciences University
• Mohamed R. Abdelraouf, Faculty of Medicine
• Hazem Mohamed Salamah, Zagazig University, Faculty of Medicine
• Eli Berglas, SUNY Downstate Health Sciences University
• Toka Elboraay, Zagazig University, Faculty of Medicine
• Abdelrahman Mahmoud, Faculty of Medicine
• Mohamed Abugdida, Faculty of Medicine
• Nadia Albaramony, School of Medicine
• Ahmed Abd Elazim, Sanford USD Medical Center
• Diana Greene-Chandos, Saint Louis University School of Medicine
• Mohammad El-Ghanem, Tilman J. Fertitta Family College of Medicine
• Volodymyr Vulkanov, Rutgers New Jersey Medical School
• Artem Sunik, SUNY Downstate Health Sciences University
• Amit Khaneja, SUNY Downstate Health Sciences University
• David P. Lerner, SUNY Downstate Health Sciences University
• Fawaz Al-Mufti, New York Medical College

DOI

10.18700/jnc.250030

Journal Title

Journal of Neurocritical Care

First Page

52

Last Page

63

Document Type

Article

Publication Date

12-29-2025

Department

Surgery

Keywords

Extended time window, Ischemic stroke, Meta-analysis, Plasminogen activators, Tenecteplase, Thrombolytic therapy

Disciplines

Medicine and Health Sciences

Abstract

Background: In acute ischemic stroke (AIS), the treatment window for thrombolytics is 4.5 hours from symptom onset. Tenecteplase, a modified tissue plasminogen activator, may be effective over an extended treatment window (4.5–24 hours). Hence, a meta-analysis was performed to evaluate tenecteplase use within an extended treatment window. Methods: Databases were searched for articles published before July 3, 2024. Randomized controlled trials (RCTs) that compared tenecteplase treatment in an extended treatment window with the current standard of care were included. The endpoints were excellent functional outcomes (modified Rankin Scale [mRS] 0–1) at 90 days, National Institutes of Health Stroke Scale (NIHSS) score change at 24 hours and 7 days, and symptomatic intracranial hemorrhage (sICH) at 90 days. The pooled risk ratio (RR) and mean difference (MD) were calculated for categorical and continuous outcomes, respectively. Results: Four RCTs involving 1,629 patients with AIS were included. High-quality evidence indicated that tenecteplase achieved a higher likelihood of mRS 0–1 at 90 days (RR, 1.21; 95% confidence interval [CI], 1.06 to 1.38; P=0.004) and a lower NIHSS score change at 24 hours (MD, −0.84; 95% CI, −1.40 to −0.27; P=0.003) than that of the placebo. Low-quality evidence showed that tenecteplase reduced the NIHSS score change at 7 days (MD, −0.79; 95% CI, −1.56 to −0.03; P=0.04). No differences in sICH or mortality were observed. Conclusion: Tenecteplase compared favorably with non-thrombolytic therapy in an extended treatment window. Future RCTs may establish tenecteplase as the standard of care for up to 24 hours.

Recommended Citation

Kelani, H., Abdelraouf, M., Salamah, H., Berglas, E., Elboraay, T., Mahmoud, A., Abugdida, M., Albaramony, N., Elazim, A., Greene-Chandos, D., El-Ghanem, M., Vulkanov, V., Sunik, A., Khaneja, A., Lerner, D., & Al-Mufti, F. (2025). Efficacy and Safety of Tenecteplase for Acute Ischemic Stroke Within an Extended Treatment Window: A Systematic Review, Meta-Analysis, and Trial Sequential Analysis of Randomized Controlled Trials. Journal of Neurocritical Care, 18 (2), 52-63. https://doi.org/10.18700/jnc.250030