Clinical Research
Antithrombotic Therapy
A Randomized, Double-Blind, Multicenter Comparison Study of Triple Antiplatelet Therapy With Dual Antiplatelet Therapy to Reduce Restenosis After Drug-Eluting Stent Implantation in Long Coronary Lesions: Results From the DECLARE-LONG II (Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients with Long Coronary Lesions) Trial

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Objectives

The purpose of this study was to determine whether cilostazol reduces intimal hyperplasia in patients undergoing long zotarolimus-eluting stent implantation (stent length: ≥30 mm) for native long coronary lesions (length: ≥25 mm).

Background

Restenosis after drug-eluting stent implantation remains a significant clinical problem in long coronary lesions.

Methods

Patients (n = 499) were assigned randomly to triple (aspirin, clopidogrel, and cilostazol, triple group: n = 250) or dual antiplatelet therapy (aspirin and clopidogrel and placebo, dual group: n = 249) for 8 months after long zotarolimus-eluting stent implantation. The primary end point was in-stent late loss at the 8-month angiography according to the intention-to-treat principle.

Results

The 2 groups had similar baseline characteristics. The in-stent (0.56 ± 0.55 mm vs. 0.68 ± 0.59 mm, p = 0.045) and in-segment (0.32 ± 0.54 mm vs. 0.47 ± 0.54 mm, p = 0.006) late loss were significantly lower in the triple versus dual group, as were 8-month in-stent restenosis (10.8% vs. 19.1%, p = 0.016), in-segment restenosis (12.2% vs. 20.0%, p = 0.028), and 12-month ischemic-driven target lesion revascularization (5.2% vs. 10.0%, p = 0.042) rates. At 12 months, major adverse cardiac events including death, myocardial infarction, and ischemic-driven target lesion revascularization tended to be lower in the triple group than the dual group (7.2% vs. 12.0%, p = 0.07). Percent intimal hyperplasia volume by volumetric intravascular ultrasound analysis was reduced from 27.1 ± 13.2% for the dual group to 22.1 ± 9.9% for the triple group (p = 0.017).

Conclusions

Patients receiving triple antiplatelet therapy after long zotarolimus-eluting stent implantation had decreased extent of late luminal loss, percent intimal hyperplasia volume, and angiographic restenosis, resulting in a reduced risk of 12-month target lesion revascularization compared with patients receiving dual antiplatelet therapy. (Triple Versus Dual Antiplatelet Therapy after ABT578-Eluting Stent; NCT00589927)

Key Words

cilostazol
coronary artery disease
triple antiplatelet therapy
zotarolimus-eluting stent

Abbreviations and Acronyms

BMS
bare-metal stent(s)
CI
confidence interval
DES
drug-eluting stent(s)
EEM
external elastic membrane
IVUS
intravascular ultrasound
MI
myocardial infarction
QCA
quantitative coronary angiography
TLR
target lesion revascularization
TVR
target vessel revascularization
ZES
zotarolimus-eluting stent(s)

Cited by (0)

DECLARE-LONG II was supported by Korea Otsuka Pharmaceutical Co., Ltd (funding source), and the Cardiovascular Research Foundation, Seoul, Korea. Korea Otsuka Pharmaceutical Co., Ltd., had no role in the study design, data collection, data analysis, or data interpretation; had no access to the clinical trial database; and did not have the opportunity to review or comment on the report.

For full author disclosures, please see the end of this paper.