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).

Abstract

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.

• Authors: Seung-Whan Lee, Seong-Wook Park, Young-Hak Kim, Sung-Cheol Yun, Duk-Woo Park, Cheol Whan Lee, Myeong-Ki Hong, Hyun-Sook Kim, Jae-Ki Ko, Jae-Hyeong Park, Jae-Hwan Lee, Si Wan Choi, In-Whan Seong, Yoon Haeng Cho, Nae-Hee Lee, June Hong Kim, Kook-Jin Chun, Seung-Jung Park
• Journal: Journal of the American College of Cardiology (J Am Coll Cardiol) Vol. 51 Issue 12 Pg. 1181-7 (Mar 25 2008) ISSN: 1558-3597 [Electronic] United States
• PMID: 18355656 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Platelet Aggregation Inhibitors
• Tetrazoles
• Clopidogrel
• Cilostazol
• Ticlopidine
• Aspirin

Topics

• Aged
• Aspirin (administration & dosage)
• Cilostazol
• Clopidogrel
• Coronary Angiography
• Coronary Artery Disease (diagnostic imaging, therapy)
• Coronary Restenosis (complications, drug therapy)
• Coronary Vessels (drug effects)
• Diabetes Mellitus
• Diabetic Angiopathies (complications)
• Drug Therapy, Combination
• Drug-Eluting Stents
• Female
• Humans
• Hyperplasia
• Male
• Middle Aged
• Platelet Aggregation Inhibitors (administration & dosage)
• Tetrazoles (administration & dosage)
• Ticlopidine (administration & dosage, analogs & derivatives)
• Treatment Outcome
• Tunica Intima (drug effects)