Rationale and design of the randomized, multicenter, cilostazol for RESTenosis (CREST) trial

• Type of Material: Article
• Authors: John S Douglas Jr., Emory University; William Seth Weintraub, Emory University; David Holmes, Emory University
• Language: English
• Date: 2003-10-01
• Publisher: Wiley Open Access: Various Creative Commons Licenses
• Publication Version: Final Published Version
• Copyright Statement: Copyright © 2003 Wiley Periodicals, Inc.
• Final Published Version (URL): http://dx.doi.org/10.1002/clc.4960261004
• Title of Journal or Parent Work: Clinical Cardiology
• ISSN: 0160-9289
• Volume: 26
• Issue: 10
• Start Page: 451
• End Page: 454
• Grant/Funding Information: This work was supported by unrestricted educational grants from Otsuka America Pharmaceutical, Inc., and Pharmacia Corporation
• Keywords: TICLOPIDINE; ARTERY DISEASE; Life Sciences & Biomedicine; THERAPY; PLACEMENT; Cardiac & Cardiovascular Systems; CORONARY STENT IMPLANTATION; cilostazol; restenosis; BALLOON ANGIOPLASTY; coronary stent; Science & Technology; Cardiovascular System & Cardiology
• Research Categories: Health Sciences, Medicine and Surgery

Abstract

Restenosis of a segment of diseased coronary artery following metallic stenting is a common clinical problem and a major limitation of the procedure. Systemic pharmacologic interventions to deal with this problem have met with little success. Several small studies suggest that cilostazol, a phosphodiesterase III inhibitor whose pharmacologic properties include antiplatelet, antithrombotic, and vasodilatory effects; a beneficial effect on serum lipids; and in vitro inhibition of smooth muscle cell proliferation, may help prevent platelet aggregation and impede the accumulation of new intimal tissue in the stented artery. The Cilostazol for RESTenosis (CREST) trial will aim to evaluate more definitively the ability of cilostazol to prevent restenosis following uncomplicated stent implantation for de novo coronary artery stenosis. In this randomized, double-blind, multicenter study, 700 patients will receive clopidogrel, aspirin, and either cilostazol or placebo after successful intracoronary stent implantation. The primary endpoint is minimal luminal diameter (MLD) of the first lesion stented after 6 months; secondary endpoints include MLD in all lesions, mean percent diameter stenosis, target lesion revascularization, and major angiographic endpoints. Safety endpoints are abnormal complete blood count and liver function tests at 1, 3, and 6 months. The trial has been initiated, and enrollment is anticipated to be concluded in 2003. Cilostazol has properties that may reduce or avert in-stent coronary restenosis. The CREST trial is a large, rigorously conducted trial that may corroborate the favorable effects of cilostazol on coronary stent restenosis suggested by earlier studies.