Comparison of Durable-Polymer Zotarolimus-Eluting and Biodegradable-Polymer Biolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: 3-Year Clinical Outcomes in the Randomized SORT OUT VI Trial

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  • Bent Raungaard, Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark. Electronic address: b.raungaard@rn.dk.
  • ,
  • Evald H Christiansen
  • Hans Erik Bøtker
  • Henrik S Hansen, Department of Cardiology, Odense University Hospital, Denmark.
  • ,
  • Jan Ravkilde, Aalborg University
  • ,
  • Leif Thuesen, Aalborg University
  • ,
  • Jens Aarøe, Aalborg University
  • ,
  • Anton B Villadsen, Aalborg University
  • ,
  • Christian J Terkelsen
  • ,
  • Lars R Krusell
  • ,
  • Michael Maeng
  • Steen D Kristensen
  • Karsten T Veien, Department of Cardiology, Odense University Hospital, Odense, Denmark.
  • ,
  • Knud N Hansen, Department of Cardiology, Odense University Hospital, Odense, Denmark.
  • ,
  • Anders Junker, Department of Cardiology, Odense University Hospital, Odense, Denmark.
  • ,
  • Morten Madsen
  • Søren L Andersen
  • ,
  • Svend E Jensen, Aalborg University
  • ,
  • Lisette O Jensen, Department of Cardiology, Odense University Hospital, Denmark.
  • ,
  • SORT OUT VI Investigators

OBJECTIVES: The authors sought to compare the safety and efficacy of the biocompatible durable-polymer zotarolimus-eluting stent with the biodegradable-polymer biolimus-eluting stent in unselected coronary patients.

BACKGROUND: Biodegradable-polymer biolimus-eluting stents are superior to first-generation durable-polymer drug-eluting stents in long-term randomized all-comer trials. Long-term data comparing them to second-generation durable-polymer drug-eluting stents are lacking.

METHODS: The study was a randomized, multicenter, all-comer, noninferiority trial in patients with chronic stable coronary artery disease or acute coronary syndromes and at least 1 coronary artery lesion requiring treatment with a drug-eluting stent. Endpoints included major adverse cardiac events (MACE), a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target lesion revascularization); the individual endpoints of MACE; all-cause mortality; any myocardial infarction; target vessel revascularization; and definite or probable stent thrombosis at 36 months.

RESULTS: From March 2011 to August 2012, 2,999 patients were randomly assigned (1:1) to receive either the zotarolimus-eluting (1,502 patients) or the biolimus-eluting (1,497 patients) stent. At 3-year follow-up, MACE occurred in 128 (8.6%) patients assigned to the durable-polymer zotarolimus-eluting stent and in 144 (9.6%) assigned to the biodegradable-polymer biolimus-eluting stent (p = 0.36). Occurrence of cardiac death (2.7% vs. 3.4%), myocardial infarction not clearly attributable to a non-target lesion (2.7% vs. 2.5%), and target lesion revascularization (5.4% vs. 5.5%) did not differ significantly between the 2 groups. Definite very late stent thrombosis occurred in 6 (0.4%) patients assigned to the durable-polymer zotarolimus-eluting stent and in 10 (0.7%) assigned to the biodegradable-polymer biolimus-eluting stent (p = 0.33).

CONCLUSIONS: At 3-year follow-up, the durable-polymer zotarolimus-eluting stent and the biodegradable-polymer biolimus-eluting stent were similar in clinical outcome, with no significant difference in safety and efficacy outcomes, including stent thrombosis.

Original languageEnglish
JournalJ A C C: Cardiovascular Interventions
Volume10
Issue3
Pages (from-to)255-264
Number of pages10
ISSN1936-8798
DOIs
Publication statusPublished - 13 Feb 2017

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