@article{WesselyHausleiterMichaelisetal., author = {Wessely, Rainer and Hausleiter, J{\"o}rg and Michaelis, Cornelia and Jaschke, Birgit and Vogeser, Michael and Milz, Stefan and Behnisch, Boris and Schratzenstaller, Thomas and Renke-Gluszko, Magdalena and St{\"o}ver, Michael and Wintermantel, Erich and Kastrati, Adnan and Sch{\"o}mig, Albert}, title = {Inhibition of neointima formation by a novel drug-eluting stent system that allows for dose-adjustable, multiple, and on-site stent coating}, series = {Arteriosclerosis, Thrombosis, and Vascular Biology}, volume = {25}, journal = {Arteriosclerosis, Thrombosis, and Vascular Biology}, number = {4}, issn = {1524-4636}, doi = {10.1161/01.ATV.0000157579.52566.ee}, pages = {748 -- 753}, 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. 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.}, language = {en} }