Background: Previous studies have shown that cilostazol may not only prevent stent thrombosis, but may also have positive effect in the prevention of restenosis. However, the effect of cilostazol on restenosis after successful deployment of drug-eluting stent (DES) in patients with diabetes mellitus has not been evaluated.
Methods and results: A total of 280 patients at 8 clinical sites were randomized. The patients (61.7+/-9.9 years old, 163 males) who underwent successful stenting were randomized to aspirin and cilostazol (group I, n=141, 61.2+/-9.6 years old) vs aspirin and clopidogrel (group II, n=139, 62.0+/-10.0 years old) after 1 month of aspirin, cilostazol, and clopidogrel combination treatment. There were no significant differences in baseline characteristics of the groups. The type of DES implanted did not differ between the groups. There were no differences in angiographic and procedural characteristics of the groups. Major adverse cardiac events, including acute and subacute stent thrombosis within 1 month, did not occur in either group. Cases of angiographic late stent thrombosis were 1 (0.9%) in group I and 1 (0.8%) in group II. Follow-up coronary angiography was performed in 237 patients (84.6%). Mean follow-up duration was 7.1 months. The rate of angiographic restenosis (stent plus 5-mm borders) was 9 (8.0%) in group I and 20 (16.1%) in group II, p=0.041). The minimal luminal diameter at follow-up period in group I was 2.55+/-0.63 mm compared with 2.41+/-0.83 mm in group II (p=NS).
Conclusions: Combination therapy with aspirin and cilostazol for the prevention of stent restenosis is comparable or superior to that of aspirin and clopidogrel in diabetic patients who undergo DES implantation.