title: Comparison of zotarolimus-eluting and everolimus-eluting coronary stents.
abstract: BACKGROUND
  New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the Food and Drug Administration.
  
  
  METHODS
  In this multicenter, noninferiority trial with minimal exclusion criteria, we randomly assigned 2292 patients to undergo treatment with coronary stents releasing either zotarolimus or everolimus. Twenty percent of patients were randomly selected for repeat angiography at 13 months. The primary end point was target-lesion failure, defined as a composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel), or clinically indicated target-lesion revascularization within 12 months. The secondary angiographic end point was the extent of in-stent stenosis at 13 months.
  
  
  RESULTS
  At least one off-label criterion for stent placement was present in 66% of patients. The zotarolimus-eluting stent was noninferior to the everolimus-eluting stent with respect to the primary end point, which occurred in 8.2% and 8.3% of patients, respectively (P<0.001 for noninferiority). There were no significant between-group differences in the rate of death from cardiac causes, any myocardial infarction, or revascularization. The rate of stent thrombosis was 2.3% in the zotarolimus-stent group and 1.5% in the everolimus-stent group (P=0.17). The zotarolimus-eluting stent was also noninferior regarding the degree (+/-SD) of in-stent stenosis (21.65+/-14.42% for zotarolimus vs. 19.76+/-14.64% for everolimus, P=0.04 for noninferiority). In-stent late lumen loss was 0.27+/-0.43 mm in the zotarolimus-stent group versus 0.19+/-0.40 mm in the everolimus-stent group (P=0.08). There were no significant between-group differences in the rate of adverse events.
  
  
  CONCLUSIONS
  At 13 months, the new-generation zotarolimus-eluting stent was found to be noninferior to the everolimus-eluting stent in a population of patients who had minimal exclusion criteria. (ClinicalTrials.gov number, NCT00617084.)
authors.affiliation: Department of Cardiology, Erasmus Medical Center, Molewaterplein 40, Ba-583, 3015 GD Rotterdam, The Netherlands. p.w.j.c.serruys@erasmusmc.nl
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Sigmund
authors.initials: S
authors.lastname: Silber
authors.forename: Scot
authors.initials: S
authors.lastname: Garg
authors.forename: Robert Jan
authors.initials: RJ
authors.lastname: van Geuns
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
authors.forename: Pawel E
authors.initials: PE
authors.lastname: Buszman
authors.forename: Henning
authors.initials: H
authors.lastname: Kelbaek
authors.forename: Adrianus Johannes
authors.initials: AJ
authors.lastname: van Boven
authors.forename: Sjoerd H
authors.initials: SH
authors.lastname: Hofma
authors.forename: Axel
authors.initials: A
authors.lastname: Linke
authors.forename: Volker
authors.initials: V
authors.lastname: Klauss
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.forename: Carlos
authors.initials: C
authors.lastname: Macaya
authors.forename: Philippe
authors.initials: P
authors.lastname: Garot
authors.forename: Carlo
authors.initials: C
authors.lastname: DiMario
authors.forename: Ganesh
authors.initials: G
authors.lastname: Manoharan
authors.forename: Ran
authors.initials: R
authors.lastname: Kornowski
authors.forename: Thomas
authors.initials: T
authors.lastname: Ischinger
authors.forename: Antonio
authors.initials: A
authors.lastname: Bartorelli
authors.forename: Jacintha
authors.initials: J
authors.lastname: Ronden
authors.forename: Marco
authors.initials: M
authors.lastname: Bressers
authors.forename: Pierre
authors.initials: P
authors.lastname: Gobbens
authors.forename: Manuela
authors.initials: M
authors.lastname: Negoita
authors.forename: Frank
authors.initials: F
authors.lastname: van Leeuwen
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
mesh_terms: D000368:Aged; D017023:Coronary Angiography; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis; D054855:Drug-Eluting Stents / Q000009:adverse effects; D000068338:Everolimus; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000628:therapy*; D011474:Prosthesis Design; D019233:Retreatment; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D017211:Treatment Failure
chemical_list: D000068338:Everolimus; C489443:zotarolimus; D020123:Sirolimus