Efficacy and Safety of Tenecteplase in Acute Ischemic Stroke: A Meta‐Analysis of Randomized Controlled Trials

Abstract

ABSTRACT

Introduction

Acute ischemic stroke (AIS) is the most common type of stroke, with increasing incidence and significant healthcare costs. Tenecteplase (TNK), a modified variant of tissue plasminogen activator (tPA), offers advantages such as a longer half‐life and single‐bolus administration. This meta‐analysis evaluates the safety and efficacy of TNK compared to non‐thrombolytic management in AIS to guide clinical decision‐making.

Methodology

A comprehensive literature search across major databases identified randomized controlled trials (RCTs) comparing tenecteplase with non‐thrombolytic care in ischemic stroke. Data extraction and bias assessment were conducted independently, using RoB 2.0 and the GRADE framework. Meta‐analysis was performed using RevMan 5.4.1, applying random‐effects models and assessing heterogeneity with the I² statistic.

Results

This meta‐analysis included seven studies with 3266 patients and found no significant difference between tenecteplase and standard medical care in terms of the mRS score at 90 days (mean difference = −0.16, p = 0.58), functional independence (mRS 0–2 at 90 days) (odds ratio = 1.07, p = 0.51), and reperfusion (TICI 2b‐3 at 24 h) (odds ratio = 1.33, p = 0.39). However, tenecteplase was associated with significantly higher mRS 0–1 at 90 days (odds ratio = 1.22, p = 0.01), better recanalization at 24 h (odds ratio = 3.28, p = 0.04), and improved NIHSS scores at 7 days (mean difference = −0.71, p = 0.003). On the downside, tenecteplase showed a significantly higher incidence of symptomatic intracranial hemorrhage (SICH) within 36 h (odds ratio = 2.24, p = 0.04) and any ICH (odds ratio = 1.40, p = 0.04), with no significant differences in mortality at 90 days (odds ratio = 1.18, p = 0.33) or stroke recurrence (odds ratio = 1.23, p = 0.55) and Barthel Index Score (odds ratio = 1.09, p = 0.69) and quality of life. Serious adverse events were slightly higher in the tenecteplase group but did not reach statistical significance (odds ratio = 1.18, p = 0.23).

Conclusion

Tenecteplase improves early neurological recovery and recanalization and provides excellent functional outcomes in acute ischemic stroke. However, it is associated with a higher risk of symptomatic and overall intracranial hemorrhage. Mortality, stroke recurrence, and overall functional independence remain unaffected.