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

The purpose of this study was to compare the clinical outcomes of patients treated with bioresorbable scaffold (BRS) for off-label versus approved indications. 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. 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). 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. 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. Comparison between treatment of “established” versus complex “off-label” coronary lesions with Absorb® bioresorbable scaffold implantation: results from the GABI-R® registry.