Clin Res Cardiol (2021) DOI DOI https://doi.org/10.1007/s00392-021-01843-w |
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First real world safety and performance analysis of the routine clinical use of the Tyrocore-based sirolimus-eluting bioresorbable coronary scaffold | ||
M. Lutz1, M. Krämer1, G. Leibundgut2, C. Kuhn3, M. Rosenberg4, N. Frey5 | ||
1Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Kiel; 2Medizin-Kardiologie, Kantonspital Baselland -Liestal, Liestal, CH; 3Kardiologische Praxis Dr. Pollert & Kollegen, Herzzentrum Landau, Landau in der Pfalz; 4Medizinische Klinik I, Klinikum Aschaffenburg, Aschaffenburg; 5Klinik für Innere Med. III, Kardiologie, Angiologie u. Pneumologie, Universitätsklinikum Heidelberg, Heidelberg; | ||
AIMS: The objective of this analysis was to evaluate the safety and performance of native coronary artery stenting using the novel Fantom Bioresorbable Scaffold in routine clinical practice. Fantom is manufactured from TyroCore, which is composed mainly of an iodinated, polycarbonate copolymer of tyrosine analogs. Fantom is completely radiopaque with thin struts (125 microns) in the 2nd generation device and as low as 95 micron struts in the 3rd generation Fantom Encore. This report evaluates the clinical outcomes of more than 80 consecutively implanted patients in routine clinical use of the Fantom Scaffold since it received CE Mark in 2017. Methods and results: This assessment includes a single center evaluation of the real world use of the Fantom BRS in every-day clinical practice. This analysis will include more than 80 patients that were treated with a total of more than 100 implanted Scaffolds over a time period of 20 months. More than 15 of the patients included in this evaluation were treated with a total of 20 third generation Fantom Encore scaffolds, which has a reduced strut thickness compared to the 2nd generation Fantom scaffold. Reported outcomes include acute technical success, acute procedural success, and a clinical procedural success rate of 97,3%. There were three incidences of restenosis (TLF) with no further Major Cardiac Adverse Events (MACE) or scaffold thrombosis through 6 months and 12 months follow-up among the patients that have reached this time point. All data available at the timepoint of the conference will be presented. 6-month and 12 month clinical outcomes for all patients as well as acute results will be presented at the conference. Up to now the 6 month MACE-rate is 2 % and there is no scaffold thrombosis. Conclusions: In this report of more than first 80 patient-report of routine clinical use, the Fantom sirolimus-eluting bioresorbable coronary demonstrated favorable safety and efficacy through 6 and 12 months. These results demonstrate the advantages of a thin strut, radiopaque bioresorbable scaffold on procedural success and early clinical outcomes in routine real-world clinical use. |
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https://dgk.org/kongress_programme/jt2021/aP541.html |