Comparison between treatment of “established” versus complex “off-label” coronary lesions with Absorb® bioresorbable scaffold implantation: results from the GABI-R® registry

Journal article


Publication Details

Author(s): Huseynov A, Baumann S, Nef H, Riemer T, Schneider S, Pfannenbecker T, Achenbach S, Mehilli J, Münzel T, Gori T, Wöhrle J, Zahn R, Kastner J, Schmermund A, Richardt G, Hamm CW, Akin I
Journal: Clinical Research in Cardiology
Publication year: 2019
ISSN: 1861-0684


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. Graphic abstract: Comparison between treatment of “established” versus complex “off-label” coronary lesions with Absorb® bioresorbable scaffold implantation: results from the GABI-R® registry.[Figure not available: see fulltext.].


FAU Authors / FAU Editors

Achenbach, Stephan Prof. Dr. med.
Medizinische Klinik 2 - Kardiologie, Angiologie


External institutions with authors

Abbott GmbH & Co. KG
Agaplesion Frankfurter Diakonie Kliniken gGmbH
IHF GmbH Institut für Herzinfarktforschung
Justus-Liebig-Universität Gießen
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Medizinische Universität Wien
Segeberger Kliniken
Universitätsklinikum Mannheim
Universitätsklinikum Ulm
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Zentralklinikum Bad Berka


How to cite

APA:
Huseynov, A., Baumann, S., Nef, H., Riemer, T., Schneider, S., Pfannenbecker, T.,... Akin, I. (2019). Comparison between treatment of “established” versus complex “off-label” coronary lesions with Absorb® bioresorbable scaffold implantation: results from the GABI-R® registry. Clinical Research in Cardiology. https://dx.doi.org/10.1007/s00392-019-01517-8

MLA:
Huseynov, Aydin, et al. "Comparison between treatment of “established” versus complex “off-label” coronary lesions with Absorb® bioresorbable scaffold implantation: results from the GABI-R® registry." Clinical Research in Cardiology (2019).

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Last updated on 2019-11-07 at 23:08