title: Methods for the economic and quality of life supplement to the cilostazol for RESTenosis (CREST) trial.
abstract: 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.
authors.affiliation: Division of Cardiology, Emory University, Atlanta, Georgia, USA. wweintr@emory.edu
authors.forename: William S
authors.initials: WS
authors.lastname: Weintraub
authors.forename: Jovonne
authors.initials: J
authors.lastname: Foster
authors.forename: Steven D
authors.initials: SD
authors.lastname: Culler
authors.forename: Edmund R
authors.initials: ER
authors.lastname: Becker
authors.forename: Kar
authors.initials: K
authors.lastname: Parker
authors.forename: Zefeng
authors.initials: Z
authors.lastname: Zhang
authors.forename: Paul
authors.initials: P
authors.lastname: Kolm
authors.forename: John S
authors.initials: JS
authors.lastname: Douglas
mesh_terms: 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
chemical_list: D010726:Phosphodiesterase Inhibitors; D010919:Placebos; D010975:Platelet Aggregation Inhibitors; D013777:Tetrazoles; D000077407:Cilostazol