Aydin Huseynov1,2, Stefan Baumann1,2, Holger Nef3, Thomas Riemer4, Steffen Schneider4, Thomas Pfannenbecker5, Stephan Achenbach6, Julinda Mehilli7, Thomas Münzel8, Tommaso Gori8, Jochen Wöhrle9, Ralf Zahn10, Johannes Kastner11, Axel Schmermund12, Gert Richardt13, Christian W Hamm3, Ibrahim Akin14,15. 1. First Department of Medicine, Faculty of Medicine Mannheim, University Medical Centre Mannheim (UMM), University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany. 2. DZHK (German Centre for Cardiovascular Research), Partner Site Heidelberg/Mannheim, Mannheim, Germany. 3. Department of Cardiology, University of Giessen, Giessen, Germany. 4. IHF GmbH, Institut für Herzinfarktforschung, Ludwigshafen, Germany. 5. Abbott Vascular Deutschland, Wetzlar, Germany. 6. Department of Cardiology, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany. 7. Department of Cardiology, Central Clinic Bad Berka, Bad Berka, Germany. 8. University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany. 9. Department of Internal Medicine II, Cardiology, University Hospital of Ulm, Ulm, Germany. 10. Deparment of Cardiology, Heart Centre Ludwigshafen, Ludwigshafen, Germany. 11. Department of Cardiology, University of Vienna Medical School, Vienna, Austria. 12. Bethanien Hospital, Frankfurt, Germany. 13. Heart Centre Segeberger Kliniken GmbH, Bad Segeberg, Germany. 14. First Department of Medicine, Faculty of Medicine Mannheim, University Medical Centre Mannheim (UMM), University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany. ibrahim.akin@umm.de. 15. DZHK (German Centre for Cardiovascular Research), Partner Site Heidelberg/Mannheim, Mannheim, Germany. ibrahim.akin@umm.de.
Abstract
OBJECTIVES: The purpose of this study was to compare the clinical outcomes of patients treated with bioresorbable scaffold (BRS) for off-label versus approved indications. BACKGROUND: The BRS promised some advantages in terms of complete biodegradation within 2-4 years, restored vascular physiology, and absence of potential stent-related long-term complications. However, the implication of BRS for off-label indications and further long-term follow-up of this particular patient group is not well described. METHODS: 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) was evaluated in the prospective, non-interventional, multicenter real-world German-Austrian ABSORB RegIstRy (GABI-R). RESULTS: A total of 3188 patients were enrolled. Patients were divided into two groups: on-label BRS use (33.0%) and off-label use (66.9%) if at least one off-label use criteria was met. The incidence of scaffold thrombosis in confirmed cases was significantly higher in off-label group (1.3% versus 0.5%, p = 0.04; OR 2.41 (95% CI 1.00-5.82) with also a trend toward higher myocardial infarction rate (2.3% versus 1.4%, p = 0.077; OR 1.70 (95% CI 0.95-3.03) and cardiovascular death (1.2% versus 1.1%, p = 0.76, OR 1.11 (95% CI 0.56-2.21) at 6-month follow-up. CONCLUSIONS: In a real-world setting, the majority patients were treated with BRS for off-label indications. The off-label use of BRS compared to confirmed indications appears to be associated with a higher rate of clinical endpoints considering more complex lesions and higher morbidity in this patients' group. Comparison between treatment of "established" versus complex "off-label" coronary lesions with Absorb® bioresorbable scaffold implantation: results from the GABI-R® registry.
OBJECTIVES: The purpose of this study was to compare the clinical outcomes of patients treated with bioresorbable scaffold (BRS) for off-label versus approved indications. BACKGROUND: The BRS promised some advantages in terms of complete biodegradation within 2-4 years, restored vascular physiology, and absence of potential stent-related long-term complications. However, the implication of BRS for off-label indications and further long-term follow-up of this particular patient group is not well described. METHODS: 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) was evaluated in the prospective, non-interventional, multicenter real-world German-Austrian ABSORB RegIstRy (GABI-R). RESULTS: A total of 3188 patients were enrolled. Patients were divided into two groups: on-label BRS use (33.0%) and off-label use (66.9%) if at least one off-label use criteria was met. The incidence of scaffold thrombosis in confirmed cases was significantly higher in off-label group (1.3% versus 0.5%, p = 0.04; OR 2.41 (95% CI 1.00-5.82) with also a trend toward higher myocardial infarction rate (2.3% versus 1.4%, p = 0.077; OR 1.70 (95% CI 0.95-3.03) and cardiovascular death (1.2% versus 1.1%, p = 0.76, OR 1.11 (95% CI 0.56-2.21) at 6-month follow-up. CONCLUSIONS: In a real-world setting, the majority patients were treated with BRS for off-label indications. The off-label use of BRS compared to confirmed indications appears to be associated with a higher rate of clinical endpoints considering more complex lesions and higher morbidity in this patients' group. Comparison between treatment of "established" versus complex "off-label" coronary lesions with Absorb® bioresorbable scaffold implantation: results from the GABI-R® registry.
Entities:
Keywords:
Bioresorbable scaffold; Coronary artery disease; Off-label use; Real-world population
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