Comparative Efficacy and Safety of Tenecteplase Versus Alteplase in Acute Ischemic Stroke: A Systematic Review and Meta-analysis of Randomized Controlled Trials
Meghana Chennupati1, Shradha Kakde2, Rakhshanda Khan3, Harshawardhan Ramteke4
1Mamata Academy of Medical Sciences, 2MGM medical college and hospital, 3Ayaan Institute of medical sciences, 4Anhui medical university
Objective:
To systematically evaluate and compare the efficacy, functional outcomes, and safety profiles of Tenecteplase and Alteplase in the management of acute ischemic stroke (AIS) using evidence from randomized controlled trials
Background:
Acute ischemic stroke (AIS) is a major global cause of death and disability. Tenecteplase, a modified tissue plasminogen activator, offers pharmacologic and practical advantages over Alteplase, including single-bolus administration and greater fibrin specificity. Recent FDA approval in 2025 highlights its potential as an alternative thrombolytic for AIS treatment.
Design/Methods:
A systematic search of MEDLINE, EMBASE, CENTRAL and SCOPUS was conducted up to October 2025 for Randomized Control Trials (RCTS). Meta-analysis was performed using Stata 18.0, and ROBS 2.0 assessed the risk of bias.
Results:
A total of 2,896 studies were screened, and 18 randomized controlled trials met inclusion criteria, involving 11,347 patients (1,710 Tenecteplase, 6,841 Alteplase, 3,068 controls). Tenecteplase showed a significant survival benefit (OR = 0.07; 95% CI 0.02–0.12) and reduced mortality compared to Alteplase (OR = 0.49; 95% CI 0.21–0.78). Rates of symptomatic cranial hemorrhage were comparable (Tenecteplase OR = 0.12; 95% CI –0.29–0.54; Alteplase OR = 0.88; 95% CI –0.24–1.86). Functional recovery favored Alteplase, showing greater improvement on the modified Rankin Scale (OR = 0.27; 95% CI 0.11–0.65) and Barthel Index (OR = 0.48; 95% CI 0.37–1.32), while Tenecteplase showed modest, non-significant effects. Infection and adverse event rates were similar, though Tenecteplase showed slightly higher injection site reactions (RR = 0.63; 95% CI 0.42–1.62). Overall, both thrombolytics demonstrated comparable safety profiles.
Conclusions:
Tenecteplase showed superior survival with comparable safety to Alteplase, while Alteplase provided better functional recovery in acute ischemic stroke. Overall, the included studies had a low risk of bias, with adequate randomization and reliable outcome reporting, supporting the robustness of the findings
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