Inhibition of neointima formation by a novel drug-eluting stent system that allows for dose-adjustable, multiple, and on-site stent coating.
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.
Wessely
Rainer
R
Deutsches Herzzentrum and 1. Medizinische Klinik, Technische Universität, Lazarettstr. 36, 80636 München, Germany. rwessely@dhm.mhn.de
Hausleiter
Jörg
J
Michaelis
Cornelia
C
Jaschke
Birgit
B
Vogeser
Michael
M
Milz
Stefan
S
Behnisch
Boris
B
Schratzenstaller
Thomas
T
Renke-Gluszko
Magdalena
M
Stöver
Michael
M
Wintermantel
Erich
E
Kastrati
Adnan
A
Schömig
Albert
A
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
D000903:Antibiotics, Antineoplastic; D020099:Coated Materials, Biocompatible; D020123:Sirolimus