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

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.

Keywords: acute ischemic stroke (AIS); hemorrhage; recanalization; tenecteplase (TNK); thrombolysis.

FIGURE 1

PRISMA flowchart of screening process.

FIGURE 2

Forest plots for EVT‐based subgroup analysis of outcomes comparing tenecteplase with standard medical treatment (SMT): (A) no disability (mRS 0–1 at 90 days), (B) functional independence (mRS 0–2 at 90 days), and (C) change in the NIHSS score at 7 days.

FIGURE 6

Forest plots of EVT‐based subgroup analysis of outcomes comparing tenecteplase with standard medical treatment (SMT): (A) serious adverse events and (B) mortality at 90 Days.

FIGURE 3

Forest plots of dosed‐based subgroup analysis of outcomes comparing tenecteplase with standard medical treatment (SMT): (A) mean mRS score at 90 days, (B) no disability(mRS 0–1 at 90 days), and (C) functional independence (mRS 0–2 at 90 days).

FIGURE 5

Forest plots for dosed‐based subgroup analysis of outcomes comparing standard medical treatment (SMT): (A) change in the NIHSS score at 7 days and (B) mortality at 90 days.

FIGURE 4

Forest plots of secondary outcomes comparing tenecteplase with standard medical treatment (SMT): (A) recanalization at 24 h, (B) reperfusion (TICI 2b‐3) at 24 h, (C) SICH within 36 h, (D) SICH within 48 h, (E) any ICH, (F) Barthel index score >95, (G) EQ‐5D‐5L (quality of life) at 90 days, and (H) stroke recurrence.