IMPORTANCE

Tirofiban is a nonpeptide antagonist of the glycoprotein IIb/IIIa receptor that inhibits platelet aggregation selectively. Despite widespread use in acute ischemic stroke in conjunction with endovascular treatment, the role of tirofiban is uncertain.

OBJECTIVE

To assess whether intravenous tirofiban initiated before endovascular thrombectomy improves thrombectomy outcomes by achieving first-pass recanalization without intracranial hemorrhagic risk.

DESIGN, SETTING, AND PARTICIPANTS: This was a multicenter, prospective, open-label, blinded, end point phase 2 randomized clinical trial that enrolled patients from 7 Chinese hospital stroke centers between April 30, 2021, and July 16, 2023. Eligible patients were aged 18 to 85 years with large vessel occlusion (internal carotid artery or M1 or M2 segment of middle cerebral artery) and were considered for endovascular thrombectomy within 24 hours of ischemic stroke onset or last known well time. Patients with a history of atrial fibrillation or treated with intravenous thrombolysis were excluded.

INTERVENTION

Patients were randomly assigned (1:1) to intravenous tirofiban (10 μg/kg bolus plus 0.1 μg/kg per minute infusion for 24 hours) or standard care before endovascular thrombectomy using a web-based, computer-generated randomization procedure.

MAIN OUTCOMES AND MEASURES

The primary outcome was the proportion of patients achieving first-pass recanalization without symptomatic intracranial hemorrhage. First-pass recanalization was assessed by reviewers blinded to treatment allocation and predefined as successful recanalization of a targeted vessel after a single pass of thrombectomy. The primary outcome was analyzed by modified Poisson regression with robust error estimation, adjusting for time from onset or last known well time to randomization and vessel occlusion site.

RESULTS

Among 200 patients randomized (median age, 66 years [IQR, 58-72 years]; 146 male [73%]), 102 were allocated to receive intravenous tirofiban, and 98 were allocated to receive standard care before endovascular thrombectomy. In the intention-to-treat analysis, 64 of 99 patients receiving tirofiban (65%) and 46 of 95 control patients (48%) achieved the primary outcome of first-pass recanalization without symptomatic intracranial hemorrhage (adjusted risk ratio, 1.34 [95% CI, 1.04-1.73]; P = .03). Incidence of symptomatic intracranial hemorrhage was 0% (0 of 101 patients) in the tirofiban group vs 6% (6 of 98 patients) in the control group (unadjusted risk difference, -0.06 [95% CI, -0.11 to -0.01]).

CONCLUSIONS AND RELEVANCE

In this randomized clinical trial of patients who had acute ischemic stroke with no history of atrial fibrillation and no prior intravenous thrombolysis, intravenous tirofiban administered before endovascular thrombectomy increased the likelihood of first-pass recanalization without symptomatic intracranial hemorrhage. These findings suggest that neurointerventionalists may consider this pre-procedure antiplatelet treatment to facilitate endovascular thrombectomy.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04851457.