The Safety of Early Intravenous Tirofiban in Acute Ischemic Stroke: A Meta-Analysis of Randomized Controlled Trials

Introduction: The aim of this study was to evaluate the hemorrhagic and mortality risks associated with early intravenous tirofiban in patients with acute ischemic stroke. Methods: We searched PubMed, Embase, Cochrane, from inception to December 23, 2025, evaluating the safety outcomes of tirofiban in acute ischemic stroke patients. The primary outcome was symptomatic intracranial hemorrhage. Results: Eleven studies (3, 635 patients) were included, with data availability varying by specific safety outcomes. Tirofiban was associated with a significant increase in the risk of any intracranial hemorrhage (risk ratios (RRs), 1.19; 95% CI, 1.02–1.38). However, there was no significant difference in the risk of the primary outcome, symptomatic intracranial hemorrhage (RR, 1.12; 95% CI, 0.56–2.22), systemic bleeding (RR, 1.20; 95% CI, 0.79–1.83), or mortality (RR, 0.93; 95% CI, 0.67–1.27). Subgroup analysis for symptomatic intracranial hemorrhage stratified by initial treatment strategy revealed no significant interaction (p = 0.29). Conclusion: Early intravenous tirofiban is associated with a significantly increased risk of any intracranial hemorrhage. Although no statistically significant increases in symptomatic intracranial hemorrhage or mortality were detected, the wide confidence intervals preclude the definitive exclusion of clinically meaningful harm.