title: APPOSITION V: STENTYS coronary stent system clinical trial in subjects with ST-segment elevation myocardial infarction--rationale and design.
abstract: BACKGROUND
  Primary percutaneous coronary intervention (PCI) has considerably improved clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) when compared with thrombolytic therapy. Prognosis after primary PCI might be further improved by decreasing stent-related complications such as stent thrombosis. The STENTYS self-apposing stent has been shown to be superior compared with balloon-expandable stents with regard to stent apposition. The current prospective randomized trial was designed to evaluate whether the superior stent apposition of the STENTYS stent results in clinical outcomes that are at least noninferior to a conventional balloon-expandable stent.
  
  
  METHODS
  The APPOSITION V is a prospective, multicenter, international, single-blinded, randomized controlled trial in STEMI patients. Randomization will be performed in a 2:1 ratio between the self-apposing nitinol bare-metal STENTYS stent and the balloon-expandable bare-metal MULTI-LINK. The primary end point is defined as target vessel failure, which is a composite of cardiac death, target vessel-related recurrent myocardial infarction, or clinically driven target vessel revascularization, at 1-year follow-up. Baseline intravascular ultrasound and optical coherence tomography (OCT) substudies will be performed in 212 and 60 subjects, respectively, and a repeat angiography at 12 to 13 months will be performed in 105 subjects, including intravascular ultrasound and OCT (in the 60 OCT patients). This study is registered on ClinicalTrials.gov with number NCT01732341.
  
  
  CONCLUSIONS
  APPOSITION V will be the first randomized trial powered on clinical end points that directly compares the STENTYS self-apposing stent with a conventional balloon-expandable stent in patients presenting with STEMI undergoing primary PCI.
authors.affiliation: Heartcenter, Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Maik J
authors.initials: MJ
authors.lastname: Grundeken
authors.affiliation: Heartcenter, Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Huangling
authors.initials: H
authors.lastname: Lu
authors.affiliation: Mount Sinai Hospital, New York, NY. Electronic address: roxana.mehran@mountsinai.org.
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, MA; Harvard Clinical Research Institute, Boston, MA.
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.affiliation: Columbia University Medical Center/New York Presbyterian, New York, NY; Cardiovascular Research Foundation, New York, NY.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.affiliation: Stanford University School of Medicine, Palo Alto, CA.
authors.forename: Alan
authors.initials: A
authors.lastname: Yeung
authors.affiliation: Heartcenter, Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Karel T
authors.initials: KT
authors.lastname: Koch
authors.affiliation: CHU La Pitié-Salpêtrière (AP-HP), Paris, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Montalescot
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Robert-Jan
authors.initials: RJ
authors.lastname: van Geuns
authors.affiliation: STENTYS S.A., Paris, France.
authors.forename: René
authors.initials: R
authors.lastname: Spaargaren
authors.affiliation: Foundation for Cardiovascular Medicine, La Jolla, CA.
authors.forename: Maurice
authors.initials: M
authors.lastname: Buchbinder
mesh_terms: D000497:Alloys; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D017023:Coronary Angiography; D023903:Coronary Restenosis; D006801:Humans; D009203:Myocardial Infarction / Q000628:therapy*; D062645:Percutaneous Coronary Intervention / Q000379:methods; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012008:Recurrence; D016037:Single-Blind Method; D015607:Stents; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D000497:Alloys; C013616:nitinol