Comparison of One-Year Outcomes of Triple (Aspirin + Clopidogrel + Cilostazol) Versus Dual Antiplatelet Therapy (Aspirin + Clopidogrel + Placebo) After Implantation of Second-Generation Drug-Eluting Stents into One or More Coronary Arteries: From the DECREASE-PCI trial

Abstract

Objective: This study sought to evaluate the impact of triple antiplatelet therapy on clinical outcomes in patients treated with second-generation drug-eluting stents (DES) for coronary artery disease. There are limited data regarding the impact of triple antiplatelet therapy in patients undergoing implantation of second-generation DES. Methods: We planned to randomly assign 2,110 patients treated with second-generation DES to triple (aspirin, clopidogrel, and cilostazol) and dual (aspirin, clopidogrel, and placebo) antiplatelet therapy groups. The primary endpoint was a composite of death, myocardial infarction (MI), ischemic stroke, or target vessel revascularization (TVR) at 1 year since randomization. Results: The study was stopped early owing to slow enrollment. In total, 404 patients (202 patients each in the triple and dual antiplatelet therapy groups) were finally enrolled. At 1 year, the primary endpoint had occurred in 3.6% and 9.4% of patients in the triple and dual antiplatelet therapy group, respectively (hazard ratio [HR] of the triple group, 0.396; 95% confidence interval [CI]: 0.166–0.949; p = 0.038). There was no significant difference between the two groups regarding the occurrence of a composite of all-cause death, MI, or ischemic stroke (HR, 0.583; 95% CI: 0.229–1.481; p = 0.256). However, the rates of TVR were significantly lower in the triple antiplatelet therapy group than in the dual antiplatelet therapy group (HR, 0.118; 95% CI: 0.015–0.930; p = 0.043). Conclusion: In conclusion, Triple antiplatelet therapy with cilostazol after implantation of second-generation DES improved clinical outcomes, mainly by reducing TVR.