title: Randomized comparison of a sirolimus-eluting Orsiro stent with a biolimus-eluting Nobori stent in patients treated with percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for Randomized Trials with Clinical Outcome VII trial.
abstract: BACKGROUND
  Third-generation coronary drug-eluting stents (DES) with biodegradable polymers have been designed to improve safety and efficacy. We designed a large scale registry-based randomized clinical trial to compare 2 third-generation DES: a thin strut, cobalt-chromium DES with silicon carbide-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the stainless steel biodegradable polymer biolimus-eluting Nobori stents (N-BES, Nobori; Terumo, Tokyo, Japan) in an all-comer patient population.
  
  
  METHODS
  The multicenter SORT OUT VII trial (NCT01879358) randomly assigned 2,530 patients to treatment with biodegradable polymer O-SES or biodegradable polymer N-BES at 3 sites in Western Denmark. Patients were eligible, if they were ≥18 years old; had chronic stable coronary artery disease or acute coronary syndromes; and ≥1 coronary lesion with >50% diameter stenosis, requiring treatment with a DES. The primary end point target lesion failure is a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 12 months. Clinically, driven event detection based on Danish registries will be used. An event rate of 6.5% is assumed in each stent group. With a sample size of 1,157 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level will have 90% power to detect noninferiority of the O-SES compared with the N-BES with a predetermined noninferiority margin of 3.0%.
  
  
  CONCLUSIONS
  The SORT OUT VII trial will determine whether the biodegradable polymers O-SES is noninferior to the N-BES with respect to driven event.
authors: Department of Cardiology, Odense University Hospital, Odense, Denmark. Electronic address: okkels@dadlnet.dk.
authors: Lisette Okkels
authors: LO
authors: Jensen
authors: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors: Per
authors: P
authors: Thayssen
authors: Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.
authors: Michael
authors: M
authors: Maeng
authors: Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
authors: Jan
authors: J
authors: Ravkilde
authors: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors: Henrik Steen
authors: HS
authors: Hansen
authors: Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
authors: Svend Eggert
authors: SE
authors: Jensen
authors: Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.
authors: Hans Erik
authors: HE
authors: Bøtker
authors: Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark.
authors: Klára
authors: K
authors: Berencsi
authors: Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.
authors: Jens Flensted
authors: JF
authors: Lassen
authors: Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.
authors: Evald Høj
authors: EH
authors: Christiansen
mesh_terms: D003324:Coronary Artery Disease / Q000601:surgery*; D003718:Denmark; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011474:Prosthesis Design; D012189:Retrospective Studies; D016037:Single-Blind Method; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology*; D012955:Societies, Medical; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; C518022:umirolimus; D020123:Sirolimus