Differential impact of cilostazol on restenosis according to implanted stent type (from a pooled analysis of three DECLARE randomized trials).

Abstract

Even in the drug-eluting stent era, restenosis has remained an unresolved issue, particularly in the treatment of complex coronary lesions. In this study, patient-level data from 3 randomized trials (Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients With Diabetes Mellitus [DECLARE-DIABETES] and Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients With Long Native Coronary Lesions [DECLARE-LONG] I and II) were pooled to estimate the differential antirestenotic efficacy of add-on cilostazol according to the implanted drug-eluting stent in patients at high risk for restenosis. A total of 1,399 patients underwent sirolimus-eluting stent (SES; n = 450), paclitaxel-eluting stent (n = 450), and zotarolimus-eluting stent (n = 499) implantation and received triple-antiplatelet therapy (TAT; aspirin, clopidogrel, and cilostazol, n = 700) and dual-antiplatelet therapy (aspirin and clopidogrel, n = 699). Randomization of antiplatelet regimen was stratified by stent type. In-stent late loss after TAT was significantly lower than that after dual-antiplatelet therapy, regardless of implanted stent type. However, the incidence of in-segment restenosis after TAT was significantly lower with SES (0.5% vs 6.7%, p = 0.014) and zotarolimus-eluting stent (12.2% vs 20.0%, p = 0.028) implantation but not paclitaxel-eluting stent implantation (14.4% vs 20.0%, p = 0.244). A significant interaction was present between stent type and antiplatelet regimen for the risk for in-segment restenosis (p = 0.004). Post hoc analysis using bootstrap resampling methods showed that the relative risk reduction for in-segment restenosis after TAT was most prominent with SES implantation. In conclusion, add-on cilostazol effectively reduced restenosis in patients at high risk for restenosis, particularly in those receiving SES, suggesting the sustainable utility of add-on cilostazol therapy in newer generation drug-eluting stents with comparable efficacy with that of SES.

• Authors: Seung-Whan Lee, Jung-Min Ahn, Seungbong Han, Gyung-Min Park, Young-Rak Cho, Woo-Seok Lee, Jeong-Yoon Jang, Chang-Hee Kwon, Jong-Young Lee, Won-Jang Kim, Soo-Jin Kang, Young-Hak Kim, Cheol-Whan Lee, Jae-Joong Kim, Seong-Wook Park, Seung-Jung Park
• Journal: The American journal of cardiology (Am J Cardiol) Vol. 112 Issue 9 Pg. 1328-34 (Nov 01 2013) ISSN: 1879-1913 [Electronic] United States
• PMID: 23890573 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 Elsevier Inc. All rights reserved.

Chemical References

• Phosphodiesterase 3 Inhibitors
• Platelet Aggregation Inhibitors
• Tetrazoles
• Cilostazol

Topics

• Cilostazol
• Coronary Angiography
• Coronary Artery Disease (surgery)
• Coronary Restenosis (diagnostic imaging, epidemiology, prevention & control)
• Dose-Response Relationship, Drug
• Drug Therapy, Combination
• Drug-Eluting Stents
• Female
• Follow-Up Studies
• Humans
• Incidence
• Male
• Middle Aged
• Phosphodiesterase 3 Inhibitors (administration & dosage, therapeutic use)
• Platelet Aggregation Inhibitors (therapeutic use)
• Prospective Studies
• Registries
• Republic of Korea (epidemiology)
• Tetrazoles (administration & dosage, therapeutic use)
• Treatment Outcome