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.

Abstract

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).

• Authors: Seung-Whan Lee, Seong-Wook Park, Young-Hak Kim, Sung-Cheol Yun, Duk-Woo Park, Cheol Whan Lee, Soo-Jin Kang, Seung-Jung Park, Jae-Hwan Lee, Si Wan Choi, In-Whan Seong, Nae-Hee Lee, Yoon Haeng Cho, Won-Yong Shin, Seung-Jin Lee, Se-Whan Lee, Min-Su Hyon, Duk-Won Bang, Young-Jin Choi, Hyun-Sook Kim, Bong-Ki Lee, Keun Lee, Hoon-Ki Park, Chang-Bum Park, Sang-Gon Lee, Min-Kyu Kim, Kyoung-Ha Park, Woo-Jung Park, DECLARE-LONG II Study Investigators
• Journal: Journal of the American College of Cardiology (J Am Coll Cardiol) Vol. 57 Issue 11 Pg. 1264-70 (Mar 15 2011) ISSN: 1558-3597 [Electronic] United States
• PMID: 21392640 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Chemical References

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

Topics

• Aged
• Aspirin (administration & dosage)
• Cilostazol
• Clopidogrel
• Coronary Artery Disease (diagnostic imaging, therapy)
• Coronary Restenosis (diagnostic imaging, etiology, prevention & control)
• Double-Blind Method
• Drug Therapy, Combination
• Drug-Eluting Stents (adverse effects)
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Platelet Aggregation Inhibitors (administration & dosage)
• Prospective Studies
• Radiography
• Tetrazoles (administration & dosage)
• Ticlopidine (administration & dosage, analogs & derivatives)
• Treatment Outcome