title: DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity (DUTCH PEERS): rationale and study design of a randomized multicenter trial in a Dutch all-comers population.
abstract: BACKGROUND
  Drug-eluting stents (DES) are increasingly used for the treatment of coronary artery disease. An optimized DES performance is desirable to successfully treat various challenging coronary lesions in a broad population of patients. In response to this demand, third-generation DES with an improved deliverability were developed. Promus Element (Boston Scientific, Natick, MA) and Resolute Integrity (Medtronic Vascular, Santa Rosa, CA) are 2 novel third-generation DES for which limited clinical data are available. Accordingly, we designed the current multicenter study to investigate in an all-comers population whether the clinical outcome is similar after stenting with Promus Element versus Resolute Integrity.
  
  
  METHODS
  DUTCH PEERS is a multicenter, prospective, single-blinded, randomized trial in a Dutch all-comers population. Patients with all clinical syndromes who require percutaneous coronary interventions with DES implantation are eligible. In these patients, the type of DES implanted will be randomized in a 1:1 ratio between Resolute Integrity versus Promus Element. The trial is powered based on a noninferiority hypothesis. For each stent arm, 894 patients will be enrolled, resulting in a total study population of 1,788 patients. The primary end point is the incidence of target vessel failure at 1-year follow-up.
  
  
  CONCLUSIONS
  DUTCH PEERS is the first randomized multicenter trial with a head-to-head comparison of Promus Element and Resolute Integrity to investigate the safety and efficacy of these third-generation DES.
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Tandjung
authors.forename: Mounir W Z
authors.initials: MW
authors.lastname: Basalus
authors.forename: Hanim
authors.initials: H
authors.lastname: Sen
authors.forename: Gillian A J
authors.initials: GA
authors.lastname: Jessurun
authors.forename: Peter W
authors.initials: PW
authors.lastname: Danse
authors.forename: Martin
authors.initials: M
authors.lastname: Stoel
authors.forename: Gerard C M
authors.initials: GC
authors.lastname: Linssen
authors.forename: Anita
authors.initials: A
authors.lastname: Derks
authors.forename: Ton T
authors.initials: TT
authors.lastname: van Loenhout
authors.forename: Mark B
authors.initials: MB
authors.lastname: Nienhuis
authors.forename: Raymond W M
authors.initials: RW
authors.lastname: Hautvast
authors.forename: Clemens
authors.initials: C
authors.lastname: von Birgelen
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D054855:Drug-Eluting Stents; D000068338:Everolimus; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D009426:Netherlands; D012107:Research Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives; D015607:Stents
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; C489443:zotarolimus; D020123:Sirolimus