title: Inhibition of neointima formation by a novel drug-eluting stent system that allows for dose-adjustable, multiple, and on-site stent coating.
abstract: OBJECTIVE
  The risk of in-stent restenosis can be considerably reduced by stents eluting cytostatic compounds. We created a novel drug-eluting stent system that includes several new features in the rapidly evolving field of stent-based drug delivery.
  
  
  RESULTS
  The aim of the present study was the preclinical evaluation of a stent-coating system permitting individual, on-site coating of stents with a unique microporous surface allowing for individualizable, dose-adjustable, and multiple coatings with identical or various compounds, designated ISAR (individualizable drug-eluting stent system to abrogate restenosis). Stents were coated with 0.75% rapamycin solution, and high-performance liquid chromatography (HPLC)-based determination of drug release profile indicated drug release for >21 days. Rapamycin-eluting microporous (REMP) stents implanted in porcine coronary arteries were safe. To determine the efficacy of REMP stents, this novel drug-eluting stent platform was compared with the standard sirolimus-eluting stent. At 30 days, in-stent neointima formation in porcine coronary arteries was similar in both groups, yielding a significant decrease of neointimal area and injury-dependent neointimal thickness compared with bare-metal stents.
  
  
  CONCLUSIONS
  The ISAR drug-eluting stent platform as a novel concept for stent coating allows for a safe, effective, on-site stent coating process, thus justifying further clinical evaluation to decrease in-stent restenosis in humans.
authors.affiliation: Deutsches Herzzentrum and 1. Medizinische Klinik, Technische Universität, Lazarettstr. 36, 80636 München, Germany. rwessely@dhm.mhn.de
authors.forename: Rainer
authors.initials: R
authors.lastname: Wessely
authors.forename: Jörg
authors.initials: J
authors.lastname: Hausleiter
authors.forename: Cornelia
authors.initials: C
authors.lastname: Michaelis
authors.forename: Birgit
authors.initials: B
authors.lastname: Jaschke
authors.forename: Michael
authors.initials: M
authors.lastname: Vogeser
authors.forename: Stefan
authors.initials: S
authors.lastname: Milz
authors.forename: Boris
authors.initials: B
authors.lastname: Behnisch
authors.forename: Thomas
authors.initials: T
authors.lastname: Schratzenstaller
authors.forename: Magdalena
authors.initials: M
authors.lastname: Renke-Gluszko
authors.forename: Michael
authors.initials: M
authors.lastname: Stöver
authors.forename: Erich
authors.initials: E
authors.lastname: Wintermantel
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.forename: Albert
authors.initials: A
authors.lastname: Schömig
mesh_terms: D000818:Animals; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000493:pharmacokinetics*; D020099:Coated Materials, Biocompatible; D023903:Coronary Restenosis / Q000473:pathology / Q000517:prevention & control*; D003331:Coronary Vessels / Q000473:pathology; D004195:Disease Models, Animal; D006801:Humans; D066298:In Vitro Techniques; D020123:Sirolimus / Q000008:administration & dosage / Q000493:pharmacokinetics*; D015607:Stents; D013552:Swine; D017539:Tunica Intima / Q000473:pathology
chemical_list: D000903:Antibiotics, Antineoplastic; D020099:Coated Materials, Biocompatible; D020123:Sirolimus