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

• Published in: Clinical research in cardiology 2020-03, Vol.109 (3), p.374-384
• Main Authors: Huseynov, Aydin, Baumann, Stefan, Nef, Holger, Riemer, Thomas, Schneider, Steffen, Pfannenbecker, Thomas, Achenbach, Stephan, Mehilli, Julinda, Münzel, Thomas, Gori, Tommaso, Wöhrle, Jochen, Zahn, Ralf, Kastner, Johannes, Schmermund, Axel, Richardt, Gert, Hamm, Christian W., Akin, Ibrahim
• Format: Article
• Language: English
• Subjects: Absorbable Implants; Aged; Biocompatibility; Biodegradation; Biomedical materials; Cardiology; Complications; Coronary Artery Disease - physiopathology; Coronary Artery Disease - therapy; Drug-Eluting Stents; Everolimus - administration & dosage; Female; Follow-Up Studies; Humans; Implantation; Implants; Lesions; Male; Medicine; Medicine & Public Health; Middle Aged; Morbidity; Myocardial infarction; Original Paper; Patients; Polyesters - chemistry; Polylactic acid; Prospective Studies; Prosthesis Design; Registries; Scaffolds; Surgical implants; Thromboembolism; Thrombosis; Time Factors; Treatment Outcome
• ISSN: 1861-0684; 1861-0692
• DOI: 10.1007/s00392-019-01517-8

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.