Abstract 12823: Efficacy, Optimal Duration and Safety of Adjunctive Cilostazol in Acute ST-elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention With Drug-Eluting Stents; a Multicenter, Randomized, Open Label, Phase 4 Trial

Abstract

Background: Previous studies showed that the triple antiplatelet therapy (TAT) which is an addition of cilostazol on the top of conventional dual antiplatelet therapy (DAT, aspirin + clopidogrel) was associated with better clinical outcomes in ST-elevation MI (STEMI) patients as compared with DAPT but the optimal duration of TAT was not determined yet. Method: A total 985 patients underwent primary percutaneous coronary intervention (PCI) with drug-eluting stents (DES) were prospectively enrolled in 14 medical centers in Korea. We randomly assigned patients into 3 groups of DAT (aspiring and clopidogrel) for 12 months, TAT (aspirin, clopidogrel and cilostazol) for 1month or 6months. The primary end point was 1-year major adverse cardiovascular events (MACE), defined as the composite of all-cause death, non-fatal myocardial infarction (MI), stroke or repeat revascularization. The secondary endpoints were the incidence of cardiac death, stent thrombosis, bleeding events and each component of primary end point. Results: The primary end point was not different among the 3 groups (8.4% in the DAT, 11.0% in the TAT for 1month, 11.3% in the TAT for 6 months, p=0.427). However, incidence of cardiac death was significantly higher in TAT groups (0.3% vs 2.5% vs 1.3%, respectively, p=0.047). Regarding in-hospital outcomes, higher bleeding events occurred in TAT groups than DAT group (0.3% vs 3.2% vs 1.9%, p=0.027) without significant difference in major bleeding. Conclusion: TAT strategy with cilostazol on the top of DAT did not associated with reduced incidence of 1-year MACE as compared with DAT but may be associated with increased cardiovascular death and bleeding risk. Whether routine additional use of cilostazol for STEMI patients would be beneficial need further studies with larger study population.