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01-03-2020 | Myocardial Infarction | Original Paper

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

Authors: Aydin Huseynov, Stefan Baumann, Holger Nef, Thomas Riemer, Steffen Schneider, Thomas Pfannenbecker, Stephan Achenbach, Julinda Mehilli, Thomas Münzel, Tommaso Gori, Jochen Wöhrle, Ralf Zahn, Johannes Kastner, Axel Schmermund, Gert Richardt, Christian W. Hamm, Ibrahim Akin

Published in: Clinical Research in Cardiology | Issue 3/2020

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.

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Title: Comparison between treatment of “established” versus complex “off-label” coronary lesions with Absorb® bioresorbable scaffold implantation: results from the GABI-R® registry
Authors: Aydin Huseynov
Stefan Baumann
Holger Nef
Thomas Riemer
Steffen Schneider
Thomas Pfannenbecker
Stephan Achenbach
Julinda Mehilli
Thomas Münzel
Tommaso Gori
Jochen Wöhrle
Ralf Zahn
Johannes Kastner
Axel Schmermund
Gert Richardt
Christian W. Hamm
Ibrahim Akin
Publication date: 01-03-2020
Publisher: Springer Berlin Heidelberg
Keywords: Myocardial Infarction
Arterial Diseases
Thrombosis
Published in: Clinical Research in Cardiology / Issue 3/2020
Print ISSN: 1861-0684
Electronic ISSN: 1861-0692
DOI: https://doi.org/10.1007/s00392-019-01517-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Objectives

Background

Methods

Results

Conclusions

Graphic abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Objectives

Background

Methods

Results

Conclusions

Graphic abstract

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