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

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 (2019)

Publication Type: Journal article

Publication year: 2019

Journal

Clinical Research in Cardiology Springer Verlag (Germany)

DOI: 10.1007/s00392-019-01517-8

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.].

Authors with CRIS profile

Stephan Achenbach Department of Medicine 2 – Cardiology and Angiology

Involved external institutions

Universitätsklinikum Mannheim DE Germany (DE) Justus-Liebig-Universität Gießen DE Germany (DE) IHF GmbH Institut für Herzinfarktforschung DE Germany (DE) Abbott GmbH & Co. KG DE Germany (DE) Zentralklinikum Bad Berka DE Germany (DE) Universitätsmedizin der Johannes Gutenberg-Universität Mainz DE Germany (DE) Universitätsklinikum Ulm DE Germany (DE) Klinikum der Stadt Ludwigshafen am Rhein gGmbH DE Germany (DE) Medizinische Universität Wien AT Austria (AT) Agaplesion Markus Krankenhaus DE Germany (DE) Segeberger Kliniken DE Germany (DE)

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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