Rationale and design of the randomized, multicenter, cilostazol for RESTenosis (CREST) trial.
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.
Division of Cardiology, Emory Center for Outcomes Research, Emory University School of Medicine, Atlanta, Georgia, USA. john_douglas@emoryhealthcare.org
John S
JS
Douglas
William S
WS
Weintraub
David
D
Holmes
D000293:Adolescent; D001241:Aspirin / Q000627:therapeutic use; D000077407:Cilostazol; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D015607:Stents; D013777:Tetrazoles / Q000627:therapeutic use*
D010726:Phosphodiesterase Inhibitors; D010975:Platelet Aggregation Inhibitors; D013777:Tetrazoles; D000077407:Cilostazol; D001241:Aspirin