P2809Comparison between treatment of “established” versus complex “off-label” coronary lesions with Absorb bioresorbable scaffold implantation: results from the GABI-R registry

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, however, the implication of BRS for off-label indications is not well described. Methods The short- and long-term outcome after implantation of a bioresorbable scaffold system (ABSORB, Abbott Vascular, USA) was evaluated in the prospective, non-interventional, multicenter real-world German-Austrian ABSORB RegIstRy (GABI-R). Results A total of 3,188 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 (1.36% vs. 0.57%, p=0.04; OR 2.41 (95% CI: 1.00–5.82) with also a trend towards higher myocardial infarction rate (2.39% vs. 1.42%, p=0.077; OR 1.70 (95% CI: 0.95–3.03) and cardiovascular death (1.27% vs. 1.14%, p=0.76, OR 1.11 (95% CI: 0.56–2.21) at 6 months follow up. Clinical outcome at 6 months Total Off-label On-label p-value* OR (95%-CI) Patients with 6m FU record 99.0% 99.0% 99.1% 0.82 0.92 (0.43–1.95) Confirmed cardiovascular death 1.22% 1.27% 1.14% 0.76 1.11 (0.56–2.21) Confirmed non-cardiovascular death 0.22% 0.14% 0.38% 0.18 0.37 (0.08–1.66) Cause unknown 0.22% 0.28% 0.09% 0.29 2.97 (0.36–24.73) Hospitalisation 27.5% 27.9% 26.7% 0.51 1.06 (0.89–1.27) MI 2.07% 2.39% 1.42% 0.07 1.70 (0.95–3.03) ARC definite scaffold thrombosis 1.10% 1.36% 0.57% 0.04 2.41 (1.00–5.82) TLF 2.70% 3.00% 2.09% 0.13 1.45 (0.89–2.37) TVF 3.98% 4.31% 3.32% 0.18 1.31 (0.88–1.95) MACE 4.33% 4.64% 3.70% 0.22 1.27 (0.87–1.85) Values are mean ± standard deviation (SD) or number and percentage (n, %). *Comparison between off-label and on-label use. The p-values are from Chi-squared test or Mann-Whitney-Wilcoxon test. ARC, academic research consortium; FU, follow up; MACE, major adverse cardiac events; PCI, percutaneous coronary intervention; TLF, target lesion failure; TVF, target vessel failure. Kaplan-Meyer curve stent thrombosis Conclusions 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. Acknowledgement/Funding This research was supported by a grant from Abbott Vascular.