title: Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation: a randomised, multicentre, open-label, controlled trial.
abstract: BACKGROUND
  We sought to compare the long-term safety of two devices with different antiproliferative properties: the Endeavor zotarolimus-eluting stent (E-ZES; Medtronic, Inc) and the Cypher sirolimus-eluting stent (C-SES; Cordis, Johnson & Johnson) in a broad group of patients and lesions.
  
  
  METHODS
  Between May 21, 2007 and Dec 22, 2008, we recruited 8791 patients from 36 recruiting countries to participate in this open-label, multicentre, randomised, superiority trial. Eligible patients were those aged 18 years or older undergoing elective, unplanned, or emergency procedures in native coronary arteries. Patients were randomly assigned to either receive E-ZES and C-SES (ratio 1:1). Randomisation was stratified per centre with varying block sizes of four, six, or eight patients, and concealed with a central telephone-based or web-based allocation service. The primary outcome was definite or probable stent thrombosis at 3 years and was analysed by intention to treat. Patients and investigators were aware of treatment assignment. This trial is registered with ClinicalTrials.gov, number NCT00476957.
  
  
  RESULTS
  PROTECT randomised 8791 patients, of whom 8709 provided consent to participate and were eligible: 4357 were allocated to the E-ZES group and 4352 patients to the C-SES group. At 3 years, rates of definite or probable stent thrombosis did not differ between groups (1·4% for E-ZES [predicted: 1·5%] vs 1·8% [predicted: 2·5%] for C-SES; hazard ratio [HR] 0·81, 95% CI 0·58-1·14, p=0·22). Dual antiplatelet therapy was used in 8402 (96%) patients at discharge, 7456 (88%) at 1 year, 3041 (37%) at 2 years, and 2364 (30%) at 3 years.
  
  
  CONCLUSIONS
  No evidence of superiority of E-ZES compared with C-SES in definite or probable stent thrombosis rates was noted at 3 years. Time analysis suggests a difference in definite or probable stent thrombosis between groups is emerging over time, and a longer follow-up is therefore needed given the clinical relevance of stent thrombosis.
  
  
  BACKGROUND
  Medtronic, Inc.
authors.affiliation: University of Geneva, Switzerland. edoardo@camenzind-cardio.net
authors.forename: Edoardo
authors.initials: E
authors.lastname: Camenzind
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
authors.forename: Volkhard
authors.initials: V
authors.lastname: Kurowski
authors.forename: Keyur
authors.initials: K
authors.lastname: Parikh
authors.forename: Runlin
authors.initials: R
authors.lastname: Gao
authors.forename: Christoph
authors.initials: C
authors.lastname: Bode
authors.forename: John P
authors.initials: JP
authors.lastname: Greenwood
authors.forename: Eric
authors.initials: E
authors.lastname: Boersma
authors.forename: Pascal
authors.initials: P
authors.lastname: Vranckx
authors.forename: Eugene
authors.initials: E
authors.lastname: McFadden
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: William W
authors.initials: WW
authors.lastname: O'Neil
authors.forename: Brenda
authors.initials: B
authors.lastname: Jorissen
authors.forename: Frank
authors.initials: F
authors.lastname: Van Leeuwen
authors.forename: Ph Gabriel
authors.initials: PG
authors.lastname: Steg
mesh_terms: D000368:Aged; D003324:Coronary Artery Disease / Q000473:pathology / Q000628:therapy; D023903:Coronary Restenosis / Q000209:etiology*; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives; D013927:Thrombosis / Q000209:etiology*
chemical_list: C489443:zotarolimus; D020123:Sirolimus