TY - JOUR A1 - Hausleiter, Jörg A1 - Kastrati, Adnan A1 - Wessely, Rainer A1 - Dibra, Alban A1 - Mehilli, Julinda A1 - Schratzenstaller, Thomas A1 - Graf, Isolde A1 - Renke-Gluszko, Magdalena A1 - Behnisch, Boris A1 - Dirschinger, Josef A1 - Wintermantel, Erich A1 - Schömig, Albert T1 - Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating JF - European Heart Journal - Clinical research N2 - Aims Drug-eluting stents (DES) represent a major advance in interventional cardiology. Along with the success shown, current DES also present limitations related to the presence of polymer-coating, fixed drug, and dose used. With the ISAR (Individualized Drug-Eluting Stent System to Abrogate Restenosis) project, a DES system has been developed that permits individualized choice of the drug and dose to use for the given patient. The objective of this prospective dose finding study was to assess the feasibility, safety, and efficacy of a polymer-free on-site stent coating with increasing rapamycin doses. Methods and results In this dose finding study, 602 patients were sequentially enrolled in four groups: microporous bare metal stent (BMS), DES stents coated with a 0.5, 1.0, and 2.0% rapamycin solution. The angiographic in-segment restenosis rate at follow-up angiography was the primary study endpoint. In-segment restenosis was significantly reduced from 25.9% with BMS to 18.9, 17.2, and 14.7% with 0.5, 1.0, and 2.0% rapamycin-eluting stents, respectively (P=0.024). Similarly, the need for target lesion revascularization at 1 year follow-up was reduced from 21.5% with BMS to 16.4, 12.6, and 8.8% with 0.5, 1.0, and 2.0% rapamycin-eluting stents, respectively (P=0.006). Conclusion The placement of polymer-free stents coated on-site with rapamycin is feasible and safe. Furthermore, a dose-dependent efficacy in restenosis prevention is achievable with this new DES concept. KW - Restenosis KW - Stents KW - Randomized KW - Rapamycin KW - Polymer Y1 - 2005 U6 - https://doi.org/10.1093/eurheartj/ehi405 VL - 26 IS - 15 SP - 1475 EP - 1481 ER - TY - JOUR A1 - Wessely, Rainer A1 - Hausleiter, Jörg A1 - Michaelis, Cornelia A1 - Jaschke, Birgit A1 - Vogeser, Michael A1 - Milz, Stefan A1 - Behnisch, Boris A1 - Schratzenstaller, Thomas A1 - Renke-Gluszko, Magdalena A1 - Stöver, Michael A1 - Wintermantel, Erich A1 - Kastrati, Adnan A1 - Schömig, Albert T1 - Inhibition of neointima formation by a novel drug-eluting stent system that allows for dose-adjustable, multiple, and on-site stent coating JF - Arteriosclerosis, Thrombosis, and Vascular Biology N2 - 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. KW - drug-eluting stent KW - stent platform KW - sirolimus KW - rapamycin Y1 - 2005 U6 - https://doi.org/10.1161/01.ATV.0000157579.52566.ee SN - 1524-4636 VL - 25 IS - 4 SP - 748 EP - 753 ER -