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(Arteriosclerosis, Thrombosis, and Vascular Biology. 2005;25:748.)
© 2005 American Heart Association, Inc.

Vascular Biology

Inhibition of Neointima Formation by a Novel Drug-Eluting Stent System That Allows for Dose-Adjustable, Multiple, and On-Site Stent Coating

Rainer Wessely; Jörg Hausleiter; Cornelia Michaelis; Birgit Jaschke; Michael Vogeser; Stefan Milz; Boris Behnisch; Thomas Schratzenstaller; Magdalena Renke-Gluszko; Michael Stöver; Erich Wintermantel; Adnan Kastrati; Albert Schömig

From Deutsches Herzzentrum and 1. Medizinische Klinik (R.W., J.H., C.M., B.J., A.K., A.S.), Technische Universität; Institut für Experimentelle Onkologie und Therapieforschung (C.M.), Technische Universität; Institut für Klinische Chemie, Ludwig-Maximilians-Universität, Klinikum Großhadern (M.V.); Anatomische Anstalt, Ludwig-Maximilians-Universität (S.M.); Translumina Labs (B.B.); and Zentralinstitut für Medizintechnik (T.S., M.R.-G., M.S., E.W.), Technische Universität, Munich, Germany.

Correspondence to Dr Rainer Wessely, Deutsches Herzzentrum and 1. Medizinische Klinik, Technische Universität, Lazarettstr. 36, 80636 München, Germany. E-mail rwessely{at}dhm.mhn.de

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.

Methods and 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.

Conclusion— 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.

In-stent neointima formation can be successfully attenuated by drug-eluting stents. We introduce a novel conceptual approach for stent-coating that allows for dose-adjustable, on-site stent coating process if desired with multiple compounds. Microporous stents coated with rapamycin proved safe and effective for the limitation of neointima formation in a porcine coronary stent model.

Key Words: drug-eluting stent • rapamycin • sirolimus • stent platform

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