Adjunctive cilostazol in patients with acute ST-elevation myocardial infarction: a multicenter, randomized, open-label, phase 4 trial

Abstract

Abstract Background/Aims Previous studies showed that triple antiplatelet therapy (TAT), involving the addition of cilostazol to conventional dual antiplatelet therapy (DAT; aspirin + clopidogrel), has better clinical outcomes in patients with ST-elevation myocardial infarction (STEMI) than that with DAT; however, the optimal duration of TAT has not yet been determined. Methods Altogether, 985 patients who 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 three groups: DAT (aspirin and clopidogrel for 12 months), TAT 1M (aspirin, clopidogrel, and cilostazol for 1 month), and TAT 6M (aspirin, clopidogrel, and cilostazol for six months). The primary endpoint was 1-year major adverse cardiovascular events (MACEs), defined as the composite of all-cause death, recurrent myocardial infarction (MI), stroke, or repeat revascularization. Results The primary endpoint was not different among the three groups (8.8% in the DAT, 11.0% in the TAT 1M, and 11.6% in the TAT 6M; hazard ratio for TAT 1M vs. DAT, 1.302; 95% confidence interval [CI], 0.792–2.141; p=0.297; hazard ratio for TAT 6M vs. DAT, 1.358; 95% CI, 0.829–2.225; p=0.225). With in-hospital outcomes, more bleeding events occurred in the TAT group than in the DAT group (1.3% vs. 4.7% vs. 2.6%, p=0.029) without significant differences in major bleeding. Besides, the TAT groups had higher incidence of headache (0% vs. 1.6% vs. 2.6%, p=0.020). Conclusions The addition of cilostazol to the DAT did not reduce the incidence of 1-year MACE compared to that with DAT alone. Instead, it may be associated with an increased risk of cumbersome side effects such as in-hospital bleeding and headaches.