Abstract 2812: A Prospective Randomized Antiplatelet Trial of Cilostazol versus Clopidogrel in Patients with Diabetes who Underwent Drug Eluting Stent Implantation (Cilostazol For Diabetic Patients In Drug-Eluting Stent CIDES trial)
Background: Previous studies have shown that cilostazol not only prevent subacute stent thrombosis, but also have positive effect in the prevention of restenosis in bare stent. However, the effect of cilostazol on restenosis after successful deployment of drug-eluting stent (DES) in patients with diabetes mellitus was not evaluated. The prospective randomized trial was designed for this purpose.
Methods: A total of 320 patients at 8 clinical sites were included. The patients who underwent successful stenting were randomized to aspirin (100 mg/day) and cilostazol (200 mg/day) (group I, n=160, 60.1±9.8 years old) vs. aspirin and clopidogrel (75 mg/day) (group II, n=160, 62.8±9.8 years old) after one month of aspirin, cilostazol, and clopidogrel combination treatment.
Results: Baseline patient characteristics were not different between the groups. The type of DES implanted was not different between the groups. There were no differences in angiographic and procedural characteristics between the groups. Acute (within 24 hours) and subacute (from 24 hours to 30 days) stent thrombosis were not observed. Late stent (>30 days) thrombosis by angiographic evidence were observed in two patients in both groups. There were no differences in bleeding, myocardial infarction, rehospitalization, or death between the groups during 1-year follow-up time. The follow-up quantitative coronary angiography (mean time ± 6.7±1.2 months) was performed in 154 patients until now. The angiographic in-stent restenosis occurred in 5.3 % of patients in cilostazol group and in 13.3 % of patients in clopidogrel group (p=0.03). Follow-up minimum lumen diameter were 2.84±0.56 mm in cilostazol group and 2.68±0.61 mm in clopidogrel group (p=NS). Late lumen loss were 0.32±0.18 mm in cilostazol group and 0.37±0.31 mm in clopidogrel group (p=NS).
Conclusion: Our results demonstrated that the effects of combination therapy with aspirin and cilostazol for the prevention of restenosis were comparable or superior to those of aspirin and clopidogrel.