Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair (TEAR): Rationale and Design of a Randomized Trial

Abstract

Backgrounds and Objective: New embolic events following stent-assisted coiling (SAC) and flow diverting (FD) procedures for unruptured intracranial aneurysms (UIA) pose a significant challenge, and the optimal perioperative antithrombotic approach remains inconsistent. This trial aims to investigate the efficacy and safety of tirofiban in reducing new diffusion-weighted imaging (DWI)-positive ischemic lesions following SAC/FD for UIA. Hypothesis: Compared to standard medical care alone, the prophylactic addition of tirofiban can reduce the DWI-positive ischemic lesions following SAC/FD for UIA without increasing the risk of bleeding. Methods: The Tirofiban for reduction of Thromboembolic Events in Endovascular unruptured Aneurysm Repair (TEAR) trial is an investigator-initiated, two-armed (1:1), prospective, randomized, open-label, masked-endpoint, superiority study. A total of 192 UIA patients receiving SAC/FD at a national stroke center will be recruited and randomized into two groups: Tirofiban group—after the femoral artery puncture, initial infusion of 0.4μg/kg/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg/minute for 24 hours. Meanwhile, routine dual antiplatelet therapy will be administered. Control group—routine dual antiplatelet therapy. The 3-T thin-slice (2mm) MRI, including diffusion weighted imaging, will be arranged for all participants within 48 hours after interventional therapy. Outcomes: The primary efficacy outcome is the number and volume of ischemic lesions on postoperative DWI within 48 hours following the procedure. The secondary efficacy outcomes include any new strokes, ischemic stroke, transient ischemic attack at postoperative 48-hour and 30-day, and disabling stroke at 30-day. The primary safety outcome is moderate and severe bleeding events, according to the GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries) criteria, within 48 hours of postoperative. Discussion: TEAR-trial will be the first randomized controlled trial to provide evidence-based recommendations for triple antiplatelet therapy (routine dual antiplatelet combined with tirofiban) to reduce DWI-positive lesions in patients with UIA who underwent SAC and FD. Trial registration: NCT06238115.