The pre-clinical assessment of rapamycin-eluting, durable polymer-free stent coating concepts.
All four currently FDA-approved drug-eluting stents (DESs) contain a durable polymeric coating which can negatively impact vascular healing processes and eventually lead to adverse cardiac events. Aim of this study was the pre-clinical assessment of two novel rapamycin-eluting stent (RES) coating technologies that abstain from use of a durable polymer. Two distinctive RES coating technologies were evaluated in vitro and in the porcine coronary artery stent model. The R-poly(S) stent platform elutes rapamycin from a biodegradable polymer that is top coated with the resin shellac to minimize the amount of polymer. The R-pro(S) stent platform allows dual drug release of rapamycin and probucol, blended by shellac. HPLC-based determination of pharmacokinetics indicated drug release for more than 28 days. At 30 days, neointimal formation was found to be significantly decreased for both DESs compared to bare-metal stents. Assessment of vascular healing revealed absence of increased inflammation in both DESs, which is commonly observed in DES with non-erodible polymeric coating. In conclusion, the pre-clinical assessment of RESs with resin-based or dual drug coating indicated an adequate efficacy profile as well as a beneficial effect for vascular healing processes. These results encourage the transfer of these technologies to clinical evaluation.
Steigerwald
Kristin
K
Deutsches Herzzentrum, Klinikum rechts der Isar, Technische Universität, Munich, Germany.
Merl
Sabine
S
Kastrati
Adnan
A
Wieczorek
Anna
A
Vorpahl
Marc
M
Mannhold
Raimund
R
Vogeser
Michael
M
Hausleiter
Jörg
J
Joner
Michael
M
Schömig
Albert
A
Wessely
Rainer
R
D000818:Animals; D020099:Coated Materials, Biocompatible; D003331:Coronary Vessels / Q000187:drug effects / Q000473:pathology; D004353:Drug Evaluation, Preclinical; D054855:Drug-Eluting Stents; D008422:Materials Testing; D008670:Metals; D011108:Polymers / Q000737:chemistry*; D020123:Sirolimus / Q000493:pharmacokinetics / Q000494:pharmacology*; D013552:Swine; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects
D020099:Coated Materials, Biocompatible; D008670:Metals; D011108:Polymers; D020123:Sirolimus