Absorb® bioresorbable scaffold in “established” versus “off-label” coronary lesions: 5-year data from the GABI-R® registry
Huseynov A, Behnes M, Nef H, Riemer T, Schneider S, Pfannebecker T, Achenbach S, Mehilli J, Münzel T, Gori T, Wöhrle J, Zahn R, Kastner J, Schmermund A, Richardt G, Hamm CW, Akin I (2025)
Publication Type: Journal article
Publication year: 2025
Journal
DOI: 10.1007/s00392-025-02707-3
Abstract
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.
Authors with CRIS profile
Involved external institutions
Justus-Liebig-Universität Gießen
Germany (DE)
Universitätsklinikum Mannheim
Germany (DE)
Segeberger Kliniken
Germany (DE)
IHF GmbH Institut für Herzinfarktforschung
Germany (DE)
Medizinische Universität Wien
Austria (AT)
Agaplesion Markus Krankenhaus
Germany (DE)
Asklepios Klinik Bad Oldesloe
Germany (DE)
Abbott GmbH & Co. KG
Germany (DE)
Krankenhaus Landshut-Achdorf (LAKUMED)
Germany (DE)
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Germany (DE)
Klinikum Friedrichshafen
Germany (DE)
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Germany (DE)
Germany (DE)
Universitätsklinikum Mannheim
Germany (DE)
Segeberger Kliniken
Germany (DE)
IHF GmbH Institut für Herzinfarktforschung
Germany (DE)
Medizinische Universität Wien
Austria (AT)
Agaplesion Markus Krankenhaus
Germany (DE)
Asklepios Klinik Bad Oldesloe
Germany (DE)
Abbott GmbH & Co. KG
Germany (DE)
Krankenhaus Landshut-Achdorf (LAKUMED)
Germany (DE)
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Germany (DE)
Klinikum Friedrichshafen
Germany (DE)
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Germany (DE)
How to cite
APA:
Huseynov, A., Behnes, M., Nef, H., Riemer, T., Schneider, S., Pfannebecker, T.,... Akin, I. (2025). Absorb® bioresorbable scaffold in “established” versus “off-label” coronary lesions: 5-year data from the GABI-R® registry. Clinical Research in Cardiology. https://doi.org/10.1007/s00392-025-02707-3
MLA:
Huseynov, Aydin, et al. "Absorb® bioresorbable scaffold in “established” versus “off-label” coronary lesions: 5-year data from the GABI-R® registry." Clinical Research in Cardiology (2025).
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