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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients With Diabetes Mellitus

The DECLARE-DIABETES Trial (A Randomized Comparison of Triple Antiplatelet Therapy With Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Diabetic Patients)

Seung-Whan Lee, MD, PhD^_*, Seong-Wook Park, MD, PhD, FACC^_*,_*, Young-Hak Kim, MD, PhD^_*, Sung-Cheol Yun, PhD^_*, Duk-Woo Park, MD, PhD^_*, Cheol Whan Lee, MD, PhD^_*, Myeong-Ki Hong, MD, PhD^_*, Hyun-Sook Kim, MD, PhD, Jae-Ki Ko, MD, PhD, Jae-Hyeong Park, MD, PhD, Jae-Hwan Lee, MD, Si Wan Choi, MD, In-Whan Seong, MD, PhD, Yoon Haeng Cho, MD, PhD, Nae-Hee Lee, MD, PhD, June Hong Kim, MD, PhD^||, Kook-Jin Chun, MD^|| and Seung-Jung Park, MD, PhD, FACC^_*

^_* Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Chonbuk National University Hospital, Jeonju, Korea
Chungnam National University Hospital, Daejeon, Korea
Soonchunhyang University Bucheon Hospital, Bucheon, Korea
^|| Busan National University Hospital, Busan, Korea.

Manuscript received August 6, 2007; revised manuscript received November 12, 2007, accepted November 13, 2007.

^_* Reprint requests and correspondence: Dr. Seong-Wook Park, Department of Medicine, University of Ulsan College of Medicine, Asan Medical Center, 388–1 Poongnap–dong, Songpa-gu, Seoul, 138-736, Korea. (Email: swpark{at}amc.seoul.kr).

Objectives: We sought to evaluate the impact of cilostazol on neointimal hyperplasia after drug-eluting stent (DES) implantation in patients with diabetes mellitus (DM).

Background: Although cilostazol has reduced the extent of neointimal hyperplasia and restenosis in patients after bare-metal stent implantation, it is not known whether this effect occurs after DES implantation in diabetic patients.

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 months.

Results: The 2 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 ± 0.50 mm vs. 0.53 ± 0.49 mm, p = 0.031) late loss were significantly lower in the triple versus standard group, as were 6-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). At 9 months, major adverse cardiac events, including death, myocardial infarction, and TLR, tended to be lower in the triple than in the standard group (3.0% vs. 7.0%, p = 0.066). Multivariate analysis showed that sirolimus-eluting stents and the use of cilostazol were strong predictors of reduced restenosis or TLR.

Conclusions: Triple antiplatelet therapy after DES implantation decreased angiographic restenosis and extent of late loss, resulting in a reduced risk of 9-month TLR compared with dual antiplatelet therapy in diabetic patients.

Abbreviations and Acronyms   BMS = bare-metal stent(s)   DES = drug-eluting stent(s)   MACE = major adverse cardiac events   MI = myocardial infarction   PES = paclitaxel-eluting stent(s)   QCA = quantitative coronary angiography   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization   TVR = target vessel revascularization

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