Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair (TEAR): A Phase 2, Randomized, Open-Label, Blinded End Point, Controlled Trial.

BACKGROUND

Thromboembolism is a common complication after interventional treatment of unruptured intracranial aneurysms. Glycoprotein IIb/IIIa inhibitor tirofiban may reduce thromboembolic complications during neurointerventional therapy for unruptured intracranial aneurysms. We aim to assess the efficacy and safety of prophylactic tirofiban in this clinical setting.

METHODS

In this investigator-initiated, phase 2, prospective, randomized, open-label, blinded end point trial (TEAR [Thromboembolic Events in Endovascular Unruptured Aneurysm Repair]), adults aged 18 years to 80 years with unruptured intracranial aneurysms suitable for neurointerventional therapy were enrolled at 2 comprehensive stroke centers in China. Patients were randomly assigned (1:1) to receive intravenous tirofiban combined with dual antiplatelet therapy or dual antiplatelet therapy alone during endovascular aneurysm repair. The primary outcome was the number and volume of new ischemic lesions on diffusion-weighted imaging within 48 hours postprocedure. Key secondary outcomes included the incidence of symptomatic stroke and hemorrhagic events within 48 hours and at 30 days.

RESULTS

Between March 2024 and October 2025, 228 patients were screened; we randomly allocated 192 patients to treatment-one individual did not receive magnetic resonance imaging because of intensive care unit hospitalization before imaging; 191 patients were enrolled (95 in the tirofiban group, 96 in the control group). Median age of the patients was 58 years; 22.0% were men, and 78.0% were women. Adjunctive tirofiban significantly reduced the median volume of new infarcts (48.6 versus 88.2 mm3, P=0.007) and showed a downward trend in the number of new infarction lesions (P=0.046). There were no significant differences between groups in symptomatic stroke, intracranial hemorrhage, or major bleeding rates at either 48 hours or 30 days (all P>0.05).

CONCLUSIONS

In this randomized, phase 2 trial, prophylactic intravenous tirofiban combined with dual antiplatelet therapy significantly reduced the new postoperative infarct lesions, without increasing hemorrhagic complications and mortality. These findings warrant validation in a multicenter, large-sample trial.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT06238115.