The comparison of tenecteplase and alteplase in acute stroke treatment: meta-analysis of 5 randomized clinical trials

Thrombolysis with the use of intravenously administrated alteplase is the only approved thrombolytic treatment of acute ischemic stroke. Tenecteplase is a fibrinolytic protein bioengineered from human tissue plasminogen activator with higher fibrin specificity, enhanced affinity to fibrin-rich clots, faster clot lysis and prolonged plasma half-life. The aim of this study was to determine which thrombolytic therapy (tenecteplase versus alteplase) provides better efficacy and safety outcomes. Eligible studies for meta-analysis published from their inception to May 2018 were identified through a search of PubMed database and two clinical trial registries websites: ClinicalTrials.gov and EU Clinical Trials Register. A meta-analysis was conducted with the use of Statistica software version 13.1. Five studies comprising 1529 patients were included. Tenecteplase 0,25mg/kg administration resulted in significantly higher number of patients with excellent score (0-1) in modified Rankin Scale at 90 days compared to alteplase group (RR 1,30, p=0,0215, 95% CI 1,04–1,62). Additionally, more patients treated with tenecteplase 0,25 mg/kg tended to develop favorable score changes in NIHSS at 24 hours after stroke onset (>8 point improvement, scale quantifying stroke severity) compared to alteplase treatment (RR 1,60, p=0,0545, 95% CI 0,99–2,58). No above correlation were observed in higher dose of tenecteplase group (0,4 mg/kg). There were no significant differences in the frequency of symptomatic intracerebral hemorrhage (ICH) and the mortality rates within 90 days after stroke onset in comparison of tenecteplase and alteplase groups. Tenecteplase 0,25 mg/kg administration in acute ischemic stroke resulted in better functional outcome at 90 days after ischemic stroke onset and tended to restrict the severity of stroke at 24 hours in NIHSS compared to alteplase 0,9 mg/kg. The frequency of symptomatic ICH occurrence and mortality within 3 months between tenecteplase and alteplase were comparable.