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

Int J Cardiol. 2017 May 1:234:58-63. doi: 10.1016/j.ijcard.2017.02.069. Epub 2017 Feb 21.

Abstract

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®-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 >12months. 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.

Keywords: ACS; Acute coronary syndrome; BVS; Bifurcations; Bioresorbable vascular scaffold; Long-term outcome.

MeSH terms

  • Absorbable Implants / adverse effects*
  • Aged
  • Coronary Angiography / methods
  • Coronary Artery Disease* / diagnosis
  • Coronary Artery Disease* / mortality
  • Coronary Artery Disease* / surgery
  • Drug-Eluting Stents / adverse effects*
  • Everolimus / therapeutic use*
  • Female
  • Germany
  • Humans
  • Immunosuppressive Agents / therapeutic use
  • Long Term Adverse Effects / diagnosis
  • Long Term Adverse Effects / etiology
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention* / adverse effects
  • Percutaneous Coronary Intervention* / instrumentation
  • Percutaneous Coronary Intervention* / methods
  • Proportional Hazards Models
  • Prosthesis Design
  • Registries
  • Risk Factors
  • Time Factors
  • Tissue Scaffolds / adverse effects*
  • Treatment Outcome

Substances

  • Immunosuppressive Agents
  • Everolimus