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

作者:Lee Seung Whan; Park Seong Wook*; Kim Young Hak; Yun Sung Cheol; Park Duk Woo; Lee Cheol Whan; Kang Soo Jin; Park Seung Jung; Lee Jae Hwan; Choi Si Wan; Seong In Whan; Lee Nae Hee; Cho Yoon Haeng; Shin Won Yong; Lee Seung Jin; Lee Se Whan; Hyon Min Su; Bang Duk Won; Choi Young Jin; Kim Hyun Sook; Lee Bong Ki; Lee Keun; Park Hoon Ki; Park Chang Bum; Lee Sang Gon; Kim Min Kyu; Park Kyoung Ha; Park Woo Jung
来源:Journal of the American College of Cardiology, 2011, 57(11): 1264-1270.
DOI:10.1016/j.jacc.2010.10.035

摘要

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.

  • 出版日期2011-3-15