Holger Nef1, Jens Wiebe2, Stefan Achenbach3, Thomas Münzel4, Christoph Naber5, Gert Richardt6, Julinda Mehilli7, Jochen Wöhrle8, Till Neumann9, Janine Biermann9, Ralf Zahn10, Johannes Kastner11, Axel Schmermund12, Thomas Pfannebecker13, Steffen Schneider14, Tobias Limbourg14, Christian W Hamm15. 1. University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen, Germany. Electronic address: holger.nef@innere.med.uni-giessen.de. 2. University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen, Germany. 3. University of Erlangen, Medizinische Klinik II, Department of Cardiology, Erlangen, Germany. 4. Department of Medicine II, University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany. 5. Klinik für Kardiologie und Angiologie, Elisabeth-Krankenhaus, Essen, Germany. 6. Herzzentrum, Segeberger Kliniken GmbH, Bad Segeberg, Germany. 7. Department of Cardiology, Klinikum Großhadern, Ludwig- Maximilian Universität, Munich, Germany. 8. Department of Internal Medicine II, University of Ulm, Ulm, Germany. 9. University of Essen, Department of Cardiology, Essen, Germany. 10. Abteilung für Kardiologie, Herzzentrum Ludwigshafen, Ludwigshafen, Germany. 11. Department of Cardiology, University of Vienna Medical School, Vienna, Austria. 12. CCB, Cardioangiologisches Centrum Bethanien, Frankfurt, Germany. 13. Abbott Vascular Deutschland GmbH, Wetzlar, Germany. 14. Institut für Herzinfarktforschung, Ludwigshafen, Germany. 15. University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen, Germany; Kerckhoff Heart and Thorax Center, Department of Cardiology, Bad Nauheim, Germany.
Abstract
BACKGROUND: Third-generation drug-eluting metal stents are the gold standard for treatment of coronary artery disease. The permanent metallic caging of the vessel, however, can result in limited vasomotion, chronic inflammation, and late expansive remodeling, conditions that can lead to late and very late stent thrombosis. The development of bioresorbable scaffolds (BRSs) promises advantages over metal stents due to complete biodegradation within 2-4years. Theoretically, since vessel scaffolding is temporary and no permanent implant remains in the vessel, BRSs, as opposed to metal stents, once degraded would no longer be potential triggers for stent-related adverse events or side effects. METHODS/ DESIGN: The short- and long-term outcome after implantation of an everolimus-eluting, poly-L-lactic acid-based bioresorbable scaffold system (ABSORB, Abbott Vascular, Santa Clara, CA, USA) in the world-wide greatest all-comers cohort will be evaluated in the prospective, non-interventional, multicenter German-Austrian ABSORB RegIstRy (GABI-R). GABI-R will include over 5000 patients from about 100 study sites in Austria and Germany. Safety endpoints such as cardiac death, myocardial infarction, and clinically driven percutaneous or surgical target lesion and vessel revascularization will be evaluated during hospitalization and in the follow-up period (minimum of 5years). CONCLUSION: Although two randomized controlled trials and several registries have documented safety and efficacy as well as non-inferiority of this everolimus-eluting ABSORB device compared with drug-eluting metal stents, the current knowledge regarding clinical application, treatment success, and long-term safety of using this BRS in daily routine is limited. Thus, the goal of GABI-R is to address this lack of information.
BACKGROUND: Third-generation drug-eluting metal stents are the gold standard for treatment of coronary artery disease. The permanent metallic caging of the vessel, however, can result in limited vasomotion, chronic inflammation, and late expansive remodeling, conditions that can lead to late and very late stent thrombosis. The development of bioresorbable scaffolds (BRSs) promises advantages over metal stents due to complete biodegradation within 2-4years. Theoretically, since vessel scaffolding is temporary and no permanent implant remains in the vessel, BRSs, as opposed to metal stents, once degraded would no longer be potential triggers for stent-related adverse events or side effects. METHODS/ DESIGN: The short- and long-term outcome after implantation of an everolimus-eluting, poly-L-lactic acid-based bioresorbable scaffold system (ABSORB, Abbott Vascular, Santa Clara, CA, USA) in the world-wide greatest all-comers cohort will be evaluated in the prospective, non-interventional, multicenter German-Austrian ABSORB RegIstRy (GABI-R). GABI-R will include over 5000 patients from about 100 study sites in Austria and Germany. Safety endpoints such as cardiac death, myocardial infarction, and clinically driven percutaneous or surgical target lesion and vessel revascularization will be evaluated during hospitalization and in the follow-up period (minimum of 5years). CONCLUSION: Although two randomized controlled trials and several registries have documented safety and efficacy as well as non-inferiority of this everolimus-eluting ABSORB device compared with drug-eluting metal stents, the current knowledge regarding clinical application, treatment success, and long-term safety of using this BRS in daily routine is limited. Thus, the goal of GABI-R is to address this lack of information.
Authors: Aydin Huseynov; Stefan Baumann; Holger Nef; Thomas Riemer; Steffen Schneider; Thomas Pfannenbecker; Stephan Achenbach; Julinda Mehilli; Thomas Münzel; Tommaso Gori; Jochen Wöhrle; Ralf Zahn; Johannes Kastner; Axel Schmermund; Gert Richardt; Christian W Hamm; Ibrahim Akin Journal: Clin Res Cardiol Date: 2019-06-29 Impact factor: 5.460
Authors: Kathrin Pahmeier; Silke Neusser; Christian Hamm; Johannes Kastner; Jochen Wöhrle; Ralf Zahn; Stephan Achenbach; Julinda Mehilli; Tommaso Gori; Christoph Naber; Holger Nef; Till Neumann; Gert Richardt; Axel Schmermund; Christoph Claas; Thomas Riemer; Janine Biermann-Stallwitz Journal: BMC Cardiovasc Disord Date: 2022-08-20 Impact factor: 2.174