Abstract TP123: Open-label Phase I Clinical Study to Assess the Safety and Efficacy of Cilostazol in Patients Undergoing Carotid Artery Angioplasty and Stent Placement

Abstract

Background: One month dual antiplatelet therapy, with Aspirin and Clopidogrel, following intra- and/or extra-cranial stent placement is the standard of care to prevent in- stent thrombosis. Cilostazol, a novel antiplatelet drug, with vasodilatory effects and smooth muscle cell proliferation inhibition, has recently been demonstrated to be safe and efficacious in secondary stroke prevention and has a safety profile comparable to both Aspirin and Clopidogrel. Objective: To evaluate the safety and clinical efficacy of Cilostazol and Aspirin therapy following internal carotid angioplasty and stent placement prior to and one month post-procedure. Methods: We conducted a Phase I open label, non-randomized single center prospective study. All patients received Aspirin (325 mg/day) and Cilostazol (200 mg/day) for at least 3 days before internal carotid stenting. The two anti-platelet agents were continued for one month after the procedure and then patients were continued on aspirin daily. The primary efficacy end point was the 30-day composite occurrence of death, stroke, TIA, and unplanned endovascular revascularization. The primary safety end point was bleeding. Bleeding complications were classified as major (hemoglobin decrease >5 g/dl), minor (hemoglobin decrease 3-5 g/dl), or insignificant. Results: Twelve patients (mean age 66±12 years; 10 men) were enrolled and underwent internal carotid angioplasty and stent placement. One patient discontinued Cilostazol after the first dose, prior to stent placement, secondary to non-specific dizziness. Another patient did not follow study protocol and continued anticoagulation dose enoxoparin with Aspirin and Cilostazol resulting in symptomatic intracerebral hemorrhage 15 hours following successful stent placement; ultimately leading to withdrawal of care. None of the patients that successfully completed the study, and followed protocol, experienced any complications at 1-month and 3-month follow up. Conclusion: The use of Cilostazol and Aspirin for carotid angioplasty and stent placement appears to be safe but protocol compliance needs to be emphasized. Further studies are required to analyze the effectiveness and role of Cilostazol in neurointerventional procedures.