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Absorb bioresorbable scaffold in “established” versus “off-label” coronary lesions: 5-year data from the GABI-R registry

Background The potential benefits of bioabsorbable stents can be better assessed over the long term. The implantation of bioresorbable scaffold (BRS) in situations with off-label indications provides real-world insights into how clinical events differ in contrast to standard proved indications. Obje...

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Main Authors: Huseynov, Aydin (Author) , Behnes, Michael (Author) , Nef, Holger (Author) , Riemer, Thomas (Author) , Schneider, Steffen (Author) , Pfannebecker, Thomas (Author) , Achenbach, Stephan (Author) , Mehilli, Julinda (Author) , Münzel, Thomas (Author) , Gori, Tommaso (Author) , Wöhrle, Jochen (Author) , Zahn, Ralf (Author) , Kastner, Johannes (Author) , Schmermund, Axel (Author) , Richardt, Gert (Author) , Hamm, Christian W. (Author) , Akın, Ibrahim (Author)
Format: Article (Journal)
Language:English
Published: August 2025
In: Clinical research in cardiology
Year: 2025, Volume: 114, Issue: 8, Pages: 1084-1094
ISSN:1861-0692
DOI:10.1007/s00392-025-02707-3
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1007/s00392-025-02707-3
Verlag, kostenfrei, Volltext: http://link.springer.com/article/10.1007/s00392-025-02707-3
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Author Notes:Aydin Huseynov, Michael Behnes, Holger Nef, Thomas Riemer, Steffen Schneider, Thomas Pfannebecker, Stephan Achenbach, Julinda Mehilli, Thomas Münzel, Tommaso Gori, Jochen Wöhrle, Ralf Zahn, Johannes Kastner, Axel Schmermund, Gert Richardt, Christian W. Hamm, Ibrahim Akin
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Summary:Background The potential benefits of bioabsorbable stents can be better assessed over the long term. The implantation of bioresorbable scaffold (BRS) in situations with off-label indications provides real-world insights into how clinical events differ in contrast to standard proved indications. Objectives The study provides long-term follow-up data about the use of bioresorbable scaffold (BRS) for off-label compared with approved indications. Methods Five-year outcome data of an everolimus-eluting, poly-L-lactic acid-based bioresorbable scaffold system (ABSORB, Abbott Vascular, Santa Clara, CA, USA) were evaluated in the prospective, non-interventional, multicenter real-world German-Austrian ABSORB-RegIstRy (GABI-R). The patients were enrolled from a total of 93 centers. Data processing and prospective follow-up were conducted centrally and independently of industry. Results A total of 3082 patients were enrolled between 2013 and 2016. Most patients were included into the off-label group (2317, 75.2%). ST-elevation myocardial infarction (STEMI) was significantly more common in the off-label group (35.9% vs. 27.8%, p = 0.003), and the extent of coronary heart disease was higher in the off-label group (coronary 3 vessel disease 28.4% vs. 22.4%, p < 0.001). Patients with off-label indications had statistically significant higher rates of stent thrombosis after 30 days (1.08% vs. 0.26%, p = 0.04) and target vessel failure (TVF) after 6 months (4.62% vs. 2.61%, p = 0.02). Conclusions The off-label use of BRS is associated with a higher rate of stent thrombosis in the short term and in the long term with higher MACE events considering more complex lesions and a higher morbidity. In the long term, there are no differences regarding stent thrombosis. Graphical Abstract
Item Description:Online veröffentlicht: 30. Juni 2025
Gesehen am 18.08.2025
Physical Description:Online Resource
ISSN:1861-0692
DOI:10.1007/s00392-025-02707-3

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