title: Randomized comparison of 6- versus 24-month clopidogrel therapy after balancing anti-intimal hyperplasia stent potency in all-comer patients undergoing percutaneous coronary intervention Design and rationale for the PROlonging Dual-antiplatelet treatment after Grading stent-induced Intimal hyperplasia study (PRODIGY).
abstract: BACKGROUND
  The optimal duration of clopidogrel therapy after coronary stenting is debated because of the scarcity of randomized controlled trials and inconsistencies arising from registry data. Although prolonged clopidogrel therapy after bare metal stenting is regarded as an effective secondary prevention measure, the safety profile of drug-eluting stents itself has been questioned in patients not receiving ≥ 12 months of dual-antiplatelet therapy.
  
  
  OBJECTIVE
  Twenty-four months of clopidogrel therapy after coronary stenting reduces the composite of death, myocardial infarction, or stroke compared with 6 months of treatment.
  
  
  METHODS
  PRODIGY is an unblinded, multicenter, 4-by-2 randomized trial. All-comer patients with indication to coronary stenting are randomly treated-balancing randomization-with bare metal stent (no active late loss inhibition), Endeavor Sprint zotarolimus-eluting stent (Medtronic, Santa Rosa, CA) (mild late loss inhibition), Taxus paclitaxel-eluting stent (Boston Scientific, Natick, MA) (moderate late loss inhibition), or Xience V everolimus-eluting stent (Abbott Vascular, Santa Clara, CA) (high late loss inhibition). At 30 days, patients in each stent group are randomly allocated to receive 24 or up to 6 months of clopidogrel therapy-primary end point randomization. With 1,700 individuals, this study will have >80% power to detect a 40% difference in the primary end point after sample size augmentation of 5% and a background event rate of 8%.
  
  
  CONCLUSIONS
  The PRODIGY trial aims to assess whether 24 months of clopidogrel therapy improves cardiovascular outcomes after coronary intervention in a broad all-comer patient population receiving a balanced mixture of stents with various anti-intimal hyperplasia potency.
authors.affiliation: Cardiology Department, University of Ferrara, Ferrara, Italy. vlgmrc@unife.it
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.forename: Gianluca
authors.initials: G
authors.lastname: Campo
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Percoco
authors.forename: Monia
authors.initials: M
authors.lastname: Monti
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Ferrari
authors.forename: Carlo
authors.initials: C
authors.lastname: Tumscitz
authors.forename: Andrea
authors.initials: A
authors.lastname: Zuffi
authors.forename: Federico
authors.initials: F
authors.lastname: Colombo
authors.forename: Moh'd
authors.initials: M
authors.lastname: Kubbajeh
authors.forename: Caterina
authors.initials: C
authors.lastname: Cavazza
authors.forename: Elisa
authors.initials: E
authors.lastname: Cangiano
authors.forename: Matteo
authors.initials: M
authors.lastname: Tebaldi
authors.forename: Monica
authors.initials: M
authors.lastname: Minarelli
authors.forename: Chiara
authors.initials: C
authors.lastname: Arcozzi
authors.forename: Antonella
authors.initials: A
authors.lastname: Scalone
authors.forename: Alice
authors.initials: A
authors.lastname: Frangione
authors.forename: Marco
authors.initials: M
authors.lastname: Borghesi
authors.forename: Jlenia
authors.initials: J
authors.lastname: Marchesini
authors.forename: Giovanni
authors.initials: G
authors.lastname: Parrinello
authors.forename: Roberto
authors.initials: R
authors.lastname: Ferrari
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000077144:Clopidogrel; D003327:Coronary Disease / Q000188:drug therapy / Q000473:pathology / Q000601:surgery*; D023903:Coronary Restenosis / Q000209:etiology / Q000473:pathology / Q000517:prevention & control*; D003331:Coronary Vessels / Q000187:drug effects / Q000473:pathology*; D004305:Dose-Response Relationship, Drug; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005500:Follow-Up Studies; D006801:Humans; D006965:Hyperplasia / Q000209:etiology / Q000473:pathology / Q000517:prevention & control; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome; D017539:Tunica Intima / Q000187:drug effects / Q000473:pathology*
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine