Abstract 2355: A Randomized Comparison of Triple Antiplatelet Therapy with Dual Antiplatelet Therapy after Drug-Eluting Stent Implantation: Drug-Eluting Stenting Followed by Cilostazol treatment reduces LAte REstenosis in Patients with DIABETES mellitus: DECLARE - DIABETES Trial
Objectives: To determine whether cilostazol improves the efficacy of drug-eluting stent (DES) in patients with diabetes mellitus (DM).
Background: Cilostazol has been reported to reduce neointimal hyperplasia and restenosis after bare-metal stent (BMS) implantation. But it is not known that its effect is extrapolated to drug eluting stent (DES) in patients with DM.
Methods: This randomized, multicenter, prospective study compared triple antiplatelet therapy (aspirin, clopidogrel and cilostazol, triple group, n=200) and dual antiplatelet therapy (aspirin and clopidogrel, standard group, n=200) for 6 months in patients with DM receiving DES. The primary end point was in-stent late loss at 6-month angiography according to the intention-to-treat principle.
Results: The both groups had similar baseline clinical and angiographic characteristics. The in-stent (0.25±0.53 mm vs. 0.38±0.54 mm, p=0.025) and in-segment (0.42±0.48 mm vs. 0.53±0.49 mm, p=0.031) late loss were significantly lower in the triple versus standard group. Six-month in-segment restenosis (8.0% vs. 15.6%, p=0.033) and 9-month target lesion revascularization (TLR) (2.5% vs. 7.0%, p=0.034) was significantly lower in triple group versus standard group. At 9 months, major adverse cardiac events (MACE) including death, myocardial infarction, and TLR had a lower tendency in triple group versus standard group (3.0% vs. 7.0%, p=0.066). Subgroup analysis showed that triple plus SES patients had significantly lower in-segment restenosis (0%, 0/88) than standard plus SES (8%, 7/88, p=0.014), triple plus PES (17.3% 13/75, p<0.001), and standard plus PES (24.1%, 19/79, p<0.001) patients. On the multivariate analysis, SES and the use cilostazol were strong predictors of restenosis and TLR.
Conclusions: In patients with DM, compared with dual antiplatelet therapy, triple antiplatelet therapy after DES implantation is associated with a decrease in angiographic restenosis as well as the extent of late luminal loss, resulting in reduced risk of 9-monthTLR.