title: First-in-man evaluation of the novel balloon delivery system STENTYS Xposition S for the self-apposing coronary artery stent: impact on longitudinal geographic miss during stenting.
abstract: OBJECTIVE
  A novel balloon delivery system (BDS) for the self-apposing STENTYS sirolimus-eluting stent (SES) has been developed for highly precise longitudinal stent positioning and deployment. The aim of this first-in-man study is to report the quantitative coronary analysis (QCA) angiography and optical coherence tomography (OCT) results as well as the 30-day clinical outcomes of the STENTYS Xposition S SES.
  
  
  RESULTS
  We included 25 patients (mean age 66.1±10.7 years) with stable coronary artery disease (24%) or acute coronary syndrome (including STEMI in 40%). The device was successfully placed at the intended site in all cases (100%), without procedural complications. Longitudinal geographic miss (entire lesion length [on QCA] not completely covered by the stent) was not observed. Pre-procedural MLD on QCA was 1.30±0.74 mm and post-procedural MLD was 2.74±0.44 mm, p<0.001 (acute gain 1.44±0.70 mm). OCT analyses showed a low percentage of malapposed stent struts directly post stent placement (2.4%), which further decreased after post-dilatation (0.6%, p=0.013), while mean stent area increased (from 9.7 mm2 to 10.5 mm2, p<0.001). At 30-day clinical follow-up, one (4%) major adverse cardiac event (MACE) was observed. One acute stent thrombosis (ST) occurred immediately post procedure in a STEMI patient which was related to inadequate medication therapy.
  
  
  CONCLUSIONS
  This first-in-man study demonstrated that the use of the novel STENTYS Xposition S balloon delivery system is feasible with a high technical success rate without longitudinal geographical miss. Stent strut malapposition rate directly after STENTYS placement was low and improved further after post-dilatation.
authors.affiliation: Department of Cardiology, Academic Medical Center - University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Huangling
authors.initials: H
authors.lastname: Lu
authors.forename: Alexander J J
authors.initials: AJ
authors.lastname: IJsselmuiden
authors.forename: Maik J
authors.initials: MJ
authors.lastname: Grundeken
authors.forename: Martina
authors.initials: M
authors.lastname: Nassif
authors.forename: Arie G
authors.initials: AG
authors.lastname: de Vries
authors.forename: Auke
authors.initials: A
authors.lastname: Weevers
authors.forename: Martijn
authors.initials: M
authors.lastname: Scholte
authors.forename: René
authors.initials: R
authors.lastname: Spaargaren
authors.forename: Joanna J
authors.initials: JJ
authors.lastname: Wykrzykowska
authors.forename: Jan G P
authors.initials: JG
authors.lastname: Tijssen
authors.forename: Robbert J
authors.initials: RJ
authors.lastname: de Winter
authors.forename: Karel T
authors.initials: KT
authors.lastname: Koch
mesh_terms: D054058:Acute Coronary Syndrome / Q000000981:diagnostic imaging / Q000628:therapy*; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D062906:Cardiac Catheters; D000072226:Computed Tomography Angiography; D017023:Coronary Angiography / Q000379:methods; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D011446:Prospective Studies; D000072657:ST Elevation Myocardial Infarction / Q000000981:diagnostic imaging / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome