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

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  • Bent Raungaard
  • Lisette Okkels Jensen, Department of Cardiology, Odense University Hospital, Odense, Denmark., Denmark
  • Hans-Henrik Tilsted, Aalborg University, Denmark
  • Evald Høj Christiansen
  • Michael Maeng
  • Christian Juhl Terkelsen
  • Lars Romer Krusell, Denmark
  • Anne Kaltoft, Denmark
  • Steen Dalby Kristensen
  • Hans Erik Bøtker
  • Leif Thuesen, Denmark
  • Jens Aarøe, Aalborg University, Denmark
  • Svend Eggert Jensen, Aalborg University, Denmark
  • Anton Boel Villadsen
  • Per Thayssen, Department of Cardiology, Odense University Hospital, Denmark
  • Karsten Tange Veien, Department of Cardiology, Odense University Hospital, Denmark
  • Knud Nørregaard Hansen, Department of Cardiology, Odense University Hospital, Denmark
  • Anders Junker, Department of Cardiology, Odense University Hospital, Denmark
  • Morten Madsen
  • Jan Ravkilde, Aalborg University, Denmark
  • Jens Flensted Lassen, Denmark
  • for the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT)

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.

FINDINGS: 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.

INTERPRETATION: The durable-polymer-coated zotarolimus-eluting stent was non-inferior to the biodegradable-polymer-coated biolimus-eluting stent in unselected patients.

FUNDING: Medtronic Cardiovascular and Biosensors Interventional Technologies.

Original languageEnglish
JournalLancet
Volume385
Issue9977
Pages (from-to)1527–1535
ISSN0140-6736
DOIs
Publication statusPublished - 15 Jan 2015

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