title: First-in-man six-month results of a surface-modified coronary stent system in native coronary stenosis.
abstract: OBJECTIVE
  In preclinical studies, a bare metal cobalt-chromium stent with an active surface oxide layer modification (BMSmod) has been shown to inhibit neointimal hyperplasia effectively. We sought to assess both the clinical safety and feasibility of the BMSmod.
  
  
  RESULTS
  In this prospective, non-randomised, first-in-man multicentre study, a total of 31 patients with de novo coronary lesions, reference lumen diameters of 2.5-3.5 mm and lesion length ≤16 mm, were enrolled. Quantitative coronary angiography and optical coherence tomography (OCT) were performed at baseline and six-month follow-up. Primary angiographic and OCT endpoints included in-stent late lumen loss (LLL) and mean neointimal thickness at six months. The device-oriented composite endpoint (DoCE), defined as cardiac death, myocardial infarction not clearly attributable to a non-intervention vessel, and clinically indicated target lesion revascularisation (CI-TLR), was analysed according to the intention-to-treat principle. In 31 patients (33 lesions), the procedural success rate was 93.5%. At six months, angiographic LLL was 0.91±0.45 mm and binary angiographic restenosis occurred in 23.3% of lesions. Out of 33 lesions, OCT was performed in 27 lesions at both time points. Mean neointimal thickness amounted to 348±116 µm. At six months, the DoCE was 19.4% due to the occurrence of CI-TLR in five patients (including one late definite stent thrombosis of a non-study stent).
  
  
  CONCLUSIONS
  In contrast to previous preclinical pathophysiological work, the BMSmod did not prevent neointimal hyperplasia in a first-in-man clinical setting.
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Pannipa
authors.initials: P
authors.lastname: Suwannasom
authors.forename: Yohei
authors.initials: Y
authors.lastname: Sotomi
authors.forename: Roberto
authors.initials: R
authors.lastname: Corti
authors.forename: David J
authors.initials: DJ
authors.lastname: Kurz
authors.forename: Marco
authors.initials: M
authors.lastname: Roffi
authors.forename: Clemens
authors.initials: C
authors.lastname: von Birgelen
authors.forename: Stefano
authors.initials: S
authors.lastname: Buzzi
authors.forename: Arik
authors.initials: A
authors.lastname: Zucker
authors.forename: Jouke
authors.initials: J
authors.lastname: Dijkstra
authors.forename: Joanna J
authors.initials: JJ
authors.lastname: Wykrzykowska
authors.forename: Robbert J
authors.initials: RJ
authors.lastname: de Winter
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Joost
authors.initials: J
authors.lastname: Daemen
authors.forename: Lorenz
authors.initials: L
authors.lastname: Räber
mesh_terms: D000368:Aged; D001807:Blood Vessel Prosthesis / Q000706:statistics & numerical data*; D023921:Coronary Stenosis / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058426:Neointima / Q000517:prevention & control*; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation* / Q000706:statistics & numerical data; D015607:Stents / Q000706:statistics & numerical data*; D013499:Surface Properties