title: Randomized comparison of sirolimus eluting, and biolimus eluting bioresorbable polymer stents: the SORT-OUT VII optical coherence tomography study.
abstract: To show non-inferiority of the 67- or 87 µm thick, sirolimus-eluting Orsiro drug eluting stent (DES) to the 122 µm thick, biolimus-eluting Nobori DES regarding size of vessel lumen outside the stent at 13-month follow-up.
  
  
  
  This study was a substudy to the SORT-OUT VII trial, a prospective, 1:1-randomized, comparison of the two stents in patients with stable coronary artery disease or acute coronary syndrome. Optical coherence tomography was acquired after percutaneous coronary intervention and at 13-month follow-up. The substudy was powered to access non-inferiority (Δ = 0.60 mm2) of the Orsiro DES to the Nobori DES for the primary endpoint of mean extra stent lumen (ESL) i.e. vessel lumen outside the stent at 13-month follow-up. We randomized 124 patients to Orsiro (n = 60) or Nobori (n = 64). Due to a difference in the one-sided 95%-confidence interval of 0.26 mm2, but increased to 0.82 mm2 after appropriate log-transformation, it could not be rejected that Orsiro exceeded the non-inferiority limit. Testing for superiority, Orsiro had a significantly larger mean ESL at follow-up (Orsiro: 0.11 mm2 [0.02;0.30] mm2, Nobori: 0.03 mm2 [0.00;0.17] mm2, P = 0.04). Stent strut coverage was, Orsiro: 97.6 % [93.8;99.4]%, and Nobori: 96.3 % [90.5;98,6]% (P = 0.13).
  
  
  
  Orsiro DES had a significantly larger mean ESL at follow-up and it could not be excluded that Orsiro exceeded the limit for non-inferiority. Nobori DES had a more heterogeneous distribution of neointima but stent strut coverage did not differ significantly between the two stents.
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Palle-Juul Jensens Boulevard 99, 8200 Aarhus N, Skejby, Denmark, Denmark.
authors.forename: Lene N
authors.initials: LN
authors.lastname: Andreasen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Palle-Juul Jensens Boulevard 99, 8200 Aarhus N, Skejby, Denmark, Denmark.
authors.forename: Niels R
authors.initials: NR
authors.lastname: Holm
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Palle-Juul Jensens Boulevard 99, 8200 Aarhus N, Skejby, Denmark, Denmark.
authors.forename: Ida R
authors.initials: IR
authors.lastname: Balleby
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Palle-Juul Jensens Boulevard 99, 8200 Aarhus N, Skejby, Denmark, Denmark.
authors.forename: Lars R
authors.initials: LR
authors.lastname: Krusell
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Palle-Juul Jensens Boulevard 99, 8200 Aarhus N, Skejby, Denmark, Denmark.
authors.forename: Michael
authors.initials: M
authors.lastname: Maeng
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Palle-Juul Jensens Boulevard 99, 8200 Aarhus N, Skejby, Denmark, Denmark.
authors.forename: Lars
authors.initials: L
authors.lastname: Jakobsen
authors.affiliation: Department of Cardiology, Odense University Hospital, Søndre Boulevard 29, 5000 Odense C, Odense, Denmark.
authors.forename: Karsten T
authors.initials: KT
authors.lastname: Veien
authors.affiliation: Department of Cardiology, Odense University Hospital, Søndre Boulevard 29, 5000 Odense C, Odense, Denmark.
authors.forename: Knud N
authors.initials: KN
authors.lastname: Hansen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Palle-Juul Jensens Boulevard 99, 8200 Aarhus N, Skejby, Denmark, Denmark.
authors.forename: Steen D
authors.initials: SD
authors.lastname: Kristensen
authors.affiliation: Institute of Clinical Medicine, Aarhus University Hospital, Skejby, Denmark.
authors.forename: Jakob
authors.initials: J
authors.lastname: Hjort
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Palle-Juul Jensens Boulevard 99, 8200 Aarhus N, Skejby, Denmark, Denmark.
authors.forename: Anne
authors.initials: A
authors.lastname: Kaltoft
authors.affiliation: Division of Image Processing, Leiden University Medical Centre, Albinusdreef 2, 2333 ZA Leiden, The Netherlands.
authors.forename: Jouke
authors.initials: J
authors.lastname: Dijkstra
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Palle-Juul Jensens Boulevard 99, 8200 Aarhus N, Skejby, Denmark, Denmark.
authors.forename: Christian J
authors.initials: CJ
authors.lastname: Terkelsen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Palle-Juul Jensens Boulevard 99, 8200 Aarhus N, Skejby, Denmark, Denmark.
authors.forename: Jens F
authors.initials: JF
authors.lastname: Lassen
authors.affiliation: Department of Clinical Epidemiology, Aarhus University Hospital, Skejby, Denmark.
authors.forename: Morten
authors.initials: M
authors.lastname: Madsen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Palle-Juul Jensens Boulevard 99, 8200 Aarhus N, Skejby, Denmark, Denmark.
authors.forename: Hans Erik
authors.initials: HE
authors.lastname: Bøtker
authors.affiliation: Department of Cardiology, Odense University Hospital, Søndre Boulevard 29, 5000 Odense C, Odense, Denmark.
authors.forename: Lisette O
authors.initials: LO
authors.lastname: Jensen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Palle-Juul Jensens Boulevard 99, 8200 Aarhus N, Skejby, Denmark, Denmark.
authors.forename: Evald H
authors.initials: EH
authors.lastname: Christiansen
mesh_terms: D020341:Absorbable Implants; D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D023921:Coronary Stenosis / Q000000981:diagnostic imaging* / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D058426:Neointima / Q000000981:diagnostic imaging / Q000473:pathology; D016011:Normal Distribution; D011108:Polymers; D011446:Prospective Studies; D011474:Prosthesis Design; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology*; D018709:Statistics, Nonparametric; D013997:Time Factors; D041623:Tomography, Optical Coherence / Q000379:methods*; D016896:Treatment Outcome; D014654:Vascular Patency / Q000502:physiology
chemical_list: D011108:Polymers; C518022:umirolimus; D020123:Sirolimus