title: Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT): rationale and study design of the randomized TWENTE III multicenter trial.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of 2 novel drug-eluting stents (DES) with biodegradable polymer-based coatings versus a durable coating DES.
  
  
  RESULTS
  BIO-RESORT is an investigator-initiated, prospective, patient-blinded, randomized multicenter trial in 3540 Dutch all-comers with various clinical syndromes, requiring percutaneous coronary interventions (PCI) with DES implantation. Randomization (stratified for diabetes mellitus) is being performed in a 1:1:1 ratio between ORSIRO sirolimus-eluting stent with circumferential biodegradable coating, SYNERGY everolimus-eluting stent with abluminal biodegradable coating, and RESOLUTE INTEGRITY zotarolimus-eluting stent with durable coating. The primary endpoint is the incidence of the composite endpoint target vessel failure at 1 year, consisting of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Power calculation assumes a target vessel failure rate of 8.5% with a 3.5% non-inferiority margin, giving the study a power of 85% (α level .025 adjusted for multiple testing). The impact of diabetes mellitus on post-PCI outcome will be evaluated. The first patient was enrolled on December 21, 2012.
  
  
  CONCLUSIONS
  BIO-RESORT is a large, prospective, randomized, multicenter trial with three arms, comparing two DES with biodegradable coatings versus a reference DES with a durable coating in 3540 all-comers. The trial will provide novel insights into the clinical outcome of modern DES and will address the impact of known and so far undetected diabetes mellitus on post-PCI outcome.
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.
authors.forename: Ming Kai
authors.initials: MK
authors.lastname: Lam
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.
authors.forename: Hanim
authors.initials: H
authors.lastname: Sen
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Tandjung
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.
authors.forename: K Gert
authors.initials: KG
authors.lastname: van Houwelingen
authors.affiliation: Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, The Netherlands.
authors.forename: Arie G
authors.initials: AG
authors.lastname: de Vries
authors.affiliation: Department of Cardiology, Rijnstate Hospital, Arnhem, The Netherlands.
authors.forename: Peter W
authors.initials: PW
authors.lastname: Danse
authors.affiliation: Department of Cardiology, Haga Hospital, The Hague, The Netherlands.
authors.forename: Carl E
authors.initials: CE
authors.lastname: Schotborgh
authors.affiliation: Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, The Netherlands.
authors.forename: Martijn
authors.initials: M
authors.lastname: Scholte
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.
authors.forename: Marije M
authors.initials: MM
authors.lastname: Löwik
authors.affiliation: Department of Cardiology, Ziekenhuisgroep Twente, Almelo and Hengelo, The Netherlands.
authors.forename: Gerard C M
authors.initials: GC
authors.lastname: Linssen
authors.affiliation: Department of Health Technology and Services Research, MIRA Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, The Netherlands.
authors.forename: Maarten J
authors.initials: MJ
authors.lastname: Ijzerman
authors.affiliation: Department of Epidemiology, Medisch Spectrum Twente, Enschede, The Netherlands; Department of Research Methodology, Measurement and Data Analysis, University of Twente, Enschede, The Netherlands.
authors.forename: Job
authors.initials: J
authors.lastname: van der Palen
authors.affiliation: Department of Health Technology and Services Research, MIRA Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, The Netherlands.
authors.forename: Carine J M
authors.initials: CJ
authors.lastname: Doggen
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands; Department of Health Technology and Services Research, MIRA Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, The Netherlands. Electronic address: c.vonbirgelen@mst.nl.
authors.forename: Clemens
authors.initials: C
authors.lastname: von Birgelen
mesh_terms: D063566:Biodegradable Plastics; D017326:Clinical Trials, Phase III as Topic / Q000379:methods*; D003324:Coronary Artery Disease / Q000601:surgery*; D054855:Drug-Eluting Stents; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011108:Polymers; D016032:Randomized Controlled Trials as Topic / Q000379:methods*
chemical_list: D063566:Biodegradable Plastics; D011108:Polymers