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).
OBJECTIVE
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.
Lee
Seung-Whan
SW
Asan Medical Center, University of Ulsan College of Medicine, Songpa-gu, Seoul, 138-736, Korea.
Park
Seong-Wook
SW
Kim
Young-Hak
YH
Yun
Sung-Cheol
SC
Park
Duk-Woo
DW
Lee
Cheol Whan
CW
Hong
Myeong-Ki
MK
Kim
Hyun-Sook
HS
Ko
Jae-Ki
JK
Park
Jae-Hyeong
JH
Lee
Jae-Hwan
JH
Choi
Si Wan
SW
Seong
In-Whan
IW
Cho
Yoon Haeng
YH
Lee
Nae-Hee
NH
Kim
June Hong
JH
Chun
Kook-Jin
KJ
Park
Seung-Jung
SJ
D000368:Aged; D001241:Aspirin / Q000008:administration & dosage; D000077407:Cilostazol; D000077144:Clopidogrel; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy; D023903:Coronary Restenosis / Q000150:complications / Q000188:drug therapy*; D003331:Coronary Vessels / Q000187:drug effects*; D003920:Diabetes Mellitus; D003925:Diabetic Angiopathies / Q000150:complications*; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D006965:Hyperplasia; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D013777:Tetrazoles / Q000008:administration & dosage*; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D016896:Treatment Outcome; D017539:Tunica Intima / Q000187:drug effects
D010975:Platelet Aggregation Inhibitors; D013777:Tetrazoles; D000077144:Clopidogrel; D000077407:Cilostazol; D013988:Ticlopidine; D001241:Aspirin