Mid- to long-term outcome of patients treated with everolimus-eluting bioresorbable vascular scaffolds: Data of the BVS registry Gottingen predominantly from ACS patients

Background: Bioresorbable vascular scaffolds (BVS) are widely used in routine clinical practice. While previous studies reported acceptable short-to midterm outcome after BVS implantation, data on longer-term outcome are rare. Methods: Patients treated with at least one Absorb (R)-BVS were consecutively enrolled. Follow-up data were assessed after 834.0 [769.0-1026.0] days. The primary device-oriented composite endpoint (DOCE) was defined as cardiovascular death, myocardial infarction (MI) and/or target lesion revascularization (TLR). Results: Between 2012 and 2014, 195 patients were included into study analysis. Overall, 244 BVS were implanted. Mean patient age was 64.0[54.3-74.0] years. Three-quarter of patients had an ACS; of those 42.9% had ST-elevation-MI and 40.8% had non-ST-elevation-MI. DOCE occurred in 3.1%, 6.7%, 11.8% and 15.4% of patients during hospital stay, within 6-months, 18-months or during the complete follow-up period, respectively. In those patients, median time until DOCE was 211.5[43.25-567.25] days. In 11 (36.7%) patients DOCE occurred after >12 months. Using univariable analysis, bifurcation stenting was associated with a hazard ratio (HR) of 11.8[2.38-58.57] for TLR (p = 0.002) and 2.1[1.02-4.49] for DOCE (p = 0.045). Similarly, in ACS patients, bifurcation stenting was associated with an increased risk for TLR (HR = 10.4[2.01-53.56]; p = 0.005) and for DOCE (HR = 2.4[1.09-5.32]; p = 0.029) and in multivariable analysis, it remained an independent predictor of DOCE (HR = 3.0; p = 0.018). Conclusions: Although, the rates of (potentially) device-related complications following BVS implantation are acceptable, they are nonetheless not negligible. Interestingly, they did not decline over time. Bifurcation stenting could be found as relevant procedure-related predictor of DOCE, especially in ACS patients. Randomized trials are warranted to confirm these findings. (C) 2017 Elsevier B.V. All rights reserved.