Methods for the economic and quality of life supplement to the cilostazol for RESTenosis (CREST) trial

To determine economic and quality of life outcomes for the Cilostazol for RESTenosis (CREST) trial, which is investigating the efficacy of cilostazol vs. placebo in preventing post-stent restenosis. CREST is a prospective, multicenter, randomized, placebo-controlled, double-blind trial. 20 clinical...

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Bibliographic Details
Published in:The Journal of invasive cardiology 2004-05, Vol.16 (5), p.257-259
Main Authors: Weintraub, William S, Foster, Jovonne, Culler, Steven D, Becker, Edmund R, Parker, Kar, Zhang, Zefeng, Kolm, Paul, Douglas, Jr, John S
Format: Article
Language:English
Subjects:
Angioplasty, Balloon, Coronary
Chemoprevention - economics
Coronary Restenosis - economics
Coronary Restenosis - prevention & control
Cost-Benefit Analysis
Female
Health Care Costs
Humans
Male
Middle Aged
Phosphodiesterase Inhibitors - economics
Phosphodiesterase Inhibitors - therapeutic use
Placebos
Platelet Aggregation Inhibitors - economics
Platelet Aggregation Inhibitors - therapeutic use
Quality-Adjusted Life Years
Randomized Controlled Trials as Topic - methods
Research Design
Surveys and Questionnaires
Tetrazoles - economics
Tetrazoles - therapeutic use
Treatment Outcome
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Summary:To determine economic and quality of life outcomes for the Cilostazol for RESTenosis (CREST) trial, which is investigating the efficacy of cilostazol vs. placebo in preventing post-stent restenosis. CREST is a prospective, multicenter, randomized, placebo-controlled, double-blind trial. 20 clinical sites; the Emory Center for Outcomes Research (ECOR) will serve as the economic and data coordinating center. 705 patients (>18 years) who have undergone successful, uncomplicated placement of an intracoronary stent in a native coronary artery. Cilostazol (100 mg twice daily) or placebo for 6 months. Primary endpoint, total direct medical costs at 6 months; secondary endpoints, initial hospital costs and follow-up costs. QOL: Health-related quality of life (QOL) will be assessed using the EQ-5D and the Seattle Angina Questionnaire at baseline and at 1, 3, and 6 months. Cost-effectiveness analysis: Preliminary data show that cilostazol is clinically superior to placebo and if the mean cost for the cilostazol arm is higher than that for placebo, cost-effectiveness analysis will be determined for the cost per episode of restenosis prevented, the cost per episode of major clinical and angiographic endpoints averted, and the cost per quality-adjusted life-years gained.
ISSN:1042-3931