title: Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI): a randomised non-inferiority trial.
abstract: BACKGROUND
  New-generation drug-eluting coronary stents have reduced the risk of coronary events, especially in patients with complex disease or lesions. To what extent different stent platforms, polymers, and antiproliferative drugs affect outcomes, however, is unclear. We investigated the safety and efficacy of a third-generation stent by comparing a highly biocompatible durable-polymer-coated zotarolimus-eluting stent with a biodegradable-polymer-coated biolimus-eluting stent.
  
  
  METHODS
  This open-label, randomised, multicentre, non-inferiority trial was done at three sites across western Denmark. All patients who presented with stable coronary artery disease or acute coronary syndromes and at least one coronary artery lesion (more than 50% stenosis) from March, 2011, to August, 2012, were assessed for eligibility. Patients were randomly assigned in a 1:1 ratio to receive either the durable-polymer zotarolimus-eluting stent or the biodegradable-polymer biolimus-eluting stent. The primary endpoint was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target-lesion revascularisation) at 12 months, analysed by intention to treat. The trial was powered to assess non-inferiority of durable-polymer zotarolimus-eluting stent compared with the biodegradable-polymer biolimus-eluting stent with a predetermined non-inferiority margin of 0·025. This trial is registered with ClinicalTrials.gov, number NCT01956448.
  
  
  RESULTS
  Of 7103 screened, 1502 patients with 1883 lesions were assigned to receive the durable-polymer zotarolimus-eluting stent and 1497 patients with 1791 lesions to receive the biodegradable-polymer biolimus-eluting stent. 79 (5·3%) and 75 (5·0%) patients, respectively, met the primary endpoint (absolute risk difference 0·0025, upper limit of one-sided 95% CI 0·016%; p=0·004). The individual components of the primary endpoint did not differ significantly between stent types at 12 months.
  
  
  CONCLUSIONS
  The durable-polymer-coated zotarolimus-eluting stent was non-inferior to the biodegradable-polymer-coated biolimus-eluting stent in unselected patients.
  
  
  BACKGROUND
  Medtronic Cardiovascular and Biosensors Interventional Technologies.
authors.affiliation: Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark. Electronic address: rau@dadlnet.dk.
authors.forename: Bent
authors.initials: B
authors.lastname: Raungaard
authors.affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors.forename: Lisette Okkels
authors.initials: LO
authors.lastname: Jensen
authors.affiliation: Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
authors.forename: Hans-Henrik
authors.initials: HH
authors.lastname: Tilsted
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
authors.forename: Evald Høj
authors.initials: EH
authors.lastname: Christiansen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
authors.forename: Michael
authors.initials: M
authors.lastname: Maeng
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
authors.forename: Christian Juhl
authors.initials: CJ
authors.lastname: Terkelsen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
authors.forename: Lars Romer
authors.initials: LR
authors.lastname: Krusell
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
authors.forename: Anne
authors.initials: A
authors.lastname: Kaltoft
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
authors.forename: Steen Dalby
authors.initials: SD
authors.lastname: Kristensen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
authors.forename: Hans Erik
authors.initials: HE
authors.lastname: Bøtker
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
authors.forename: Leif
authors.initials: L
authors.lastname: Thuesen
authors.affiliation: Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
authors.forename: Jens
authors.initials: J
authors.lastname: Aarøe
authors.affiliation: Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
authors.forename: Svend Eggert
authors.initials: SE
authors.lastname: Jensen
authors.affiliation: Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
authors.forename: Anton Boel
authors.initials: AB
authors.lastname: Villadsen
authors.affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors.forename: Per
authors.initials: P
authors.lastname: Thayssen
authors.affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors.forename: Karsten Tange
authors.initials: KT
authors.lastname: Veien
authors.affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors.forename: Knud Nørregaard
authors.initials: KN
authors.lastname: Hansen
authors.affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors.forename: Anders
authors.initials: A
authors.lastname: Junker
authors.affiliation: Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Morten
authors.initials: M
authors.lastname: Madsen
authors.affiliation: Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
authors.forename: Jan
authors.initials: J
authors.lastname: Ravkilde
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
authors.forename: Jens Flensted
authors.initials: JF
authors.lastname: Lassen
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D020099:Coated Materials, Biocompatible; D003718:Denmark; D054855:Drug-Eluting Stents; D004867:Equipment Design; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D062645:Percutaneous Coronary Intervention; D011108:Polymers; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D020099:Coated Materials, Biocompatible; D007166:Immunosuppressive Agents; D011108:Polymers; C489443:zotarolimus; C518022:umirolimus; D020123:Sirolimus