@article{HausleiterKastratiWesselyetal., author = {Hausleiter, J{\"o}rg and Kastrati, Adnan and Wessely, Rainer and Dibra, Alban and Mehilli, Julinda and Schratzenstaller, Thomas and Graf, Isolde and Renke-Gluszko, Magdalena and Behnisch, Boris and Dirschinger, Josef and Wintermantel, Erich and Sch{\"o}mig, Albert}, title = {Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating}, series = {European Heart Journal - Clinical research}, volume = {26}, journal = {European Heart Journal - Clinical research}, number = {15}, doi = {10.1093/eurheartj/ehi405}, pages = {1475 -- 1481}, abstract = {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.}, language = {en} } @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} }