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


METHODS
CREST is a prospective, multicenter, randomized, placebo-controlled, double-blind trial.


METHODS
20 clinical sites; the Emory Center for Outcomes Research (ECOR) will serve as the economic and data coordinating center.


METHODS
705 patients (>18 years) who have undergone successful, uncomplicated placement of an intracoronary stent in a native coronary artery.


METHODS
Cilostazol (100 mg twice daily) or placebo for 6 months.


METHODS



RESULTS
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.
Weintraub
William S
WS
Division of Cardiology, Emory University, Atlanta, Georgia, USA. wweintr@emory.edu
Foster
Jovonne
J
Culler
Steven D
SD
Becker
Edmund R
ER
Parker
Kar
K
Zhang
Zefeng
Z
Kolm
Paul
P
Douglas
John S
JS
D015906:Angioplasty, Balloon, Coronary; D018890:Chemoprevention / Q000191:economics; D000077407:Cilostazol; D023903:Coronary Restenosis / Q000191:economics / Q000517:prevention & control*; D003362:Cost-Benefit Analysis; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000191:economics / Q000627:therapeutic use*; D010919:Placebos; D010975:Platelet Aggregation Inhibitors / Q000191:economics / Q000627:therapeutic use*; D019057:Quality-Adjusted Life Years; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D011795:Surveys and Questionnaires; D013777:Tetrazoles / Q000191:economics / Q000627:therapeutic use*; D016896:Treatment Outcome
D010726:Phosphodiesterase Inhibitors; D010919:Placebos; D010975:Platelet Aggregation Inhibitors; D013777:Tetrazoles; D000077407:Cilostazol