Abstract 14940: Impact of Cilostazol on Major Adverse Cardiac and Cerebrovascular Events in Patients with Coronary Stent Implantation: First Report of Cilostazol and Aspirin versus Aspirin Therapy against Vascular Events after Coronary Stent Implantation (CATS-I) Trial
Background: The optimal duration of combination antiplatelet therapy for prevention of vascular events in patients undergoing percutaneous coronary intervention is unclear. We performed a prospective randomized trial to evaluate the long-term efficacy and safety of cilostazol plus aspirin compared with aspirin in patients with coronary stent placement.
Methods: From May 2008 to May 2009, a total of 200 patients who had received coronary stent placement more than 6 months previously were enrolled and randomly assigned to receive cilostazol plus aspirin (cilostazol group, n=100) or aspirin (aspirin group, n=100). The use of thienopyridine was discontinued at the time of randomization. The primary efficacy endpoint was a composite of death, myocardial infarction, stroke, transient ischemic attack, or coronary or carotid revascularization at 2 years after randomization. The primary safety endpoint was hemorrhagic events, including intracranial hemorrhage and hemorrhage requiring hospital admission.
Results: The median duration of follow-up was 30.4 months. Baseline characteristics were well balanced between the two groups. At 2 years, the primary efficacy endpoint occurred in 10.4% of patients in the cilostazol group and 24.5% of patients in the aspirin group (P=0.01). There was no significant difference in the incidence of the primary safety endpoint between the cilostazol group and the aspirin group (4.2% versus 2.0%; P=0.43). In multivariate Cox regression analysis, cilostazol was the most powerful predictor for the primary efficacy endpoint (hazard ratio for the cilostazol group versus the aspirin group, 0.39; 95% confidence interval, 0.18 to 0.81; P=0.01).
Conclusions: Treatment with cilostazol plus aspirin in patients with coronary stent placement, as compared with aspirin monotherapy, resulted in reduced rates of major adverse cardiac and cerebrovascular events at 2 years.
- © 2011 by American Heart Association, Inc.