title: Mid- to long-term outcome of patients treated with everolimus-eluting bioresorbable vascular scaffolds: Data of the BVS registry Göttingen predominantly from ACS patients.
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.
authors.affiliation: Clinic for Cardiology & Pneumology/Heart Center, University Medical Center Göttingen, DZHK - German Center for Cardiovascular Research, Germany.
authors.forename: Kristian
authors.initials: K
authors.lastname: Hellenkamp
authors.affiliation: Clinic for Cardiology & Pneumology/Heart Center, University Medical Center Göttingen, DZHK - German Center for Cardiovascular Research, Germany; Clinic for Cardiology, Robert-Bosch Hospital, Stuttgart, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Becker
authors.affiliation: Clinic for Cardiology & Pneumology/Heart Center, University Medical Center Göttingen, DZHK - German Center for Cardiovascular Research, Germany.
authors.forename: Yannick D
authors.initials: YD
authors.lastname: Gabriel
authors.affiliation: Clinic for Cardiology & Pneumology/Heart Center, University Medical Center Göttingen, DZHK - German Center for Cardiovascular Research, Germany.
authors.forename: Gerd
authors.initials: G
authors.lastname: Hasenfuß
authors.affiliation: Clinic for Cardiology & Pneumology/Heart Center, University Medical Center Göttingen, DZHK - German Center for Cardiovascular Research, Germany.
authors.forename: Mark
authors.initials: M
authors.lastname: Hünlich
authors.affiliation: Clinic for Cardiology & Pneumology/Heart Center, University Medical Center Göttingen, DZHK - German Center for Cardiovascular Research, Germany.
authors.forename: Claudius
authors.initials: C
authors.lastname: Jacobshagen
authors.affiliation: Clinic for Cardiology & Pneumology/Heart Center, University Medical Center Göttingen, DZHK - German Center for Cardiovascular Research, Germany; Medical Clinic I, Helios Albert-Schweitzer Clinic Northeim, Northeim, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Schillinger
authors.affiliation: Clinic for Cardiology & Pneumology/Heart Center, University Medical Center Göttingen, DZHK - German Center for Cardiovascular Research, Germany. Electronic address: mschroeter@med.uni-goettingen.de.
authors.forename: Marco R
authors.initials: MR
authors.lastname: Schroeter
mesh_terms: D020341:Absorbable Implants / Q000009:adverse effects*; D000368:Aged; D017023:Coronary Angiography / Q000379:methods; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000601:surgery; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D000068338:Everolimus / Q000627:therapeutic use*; D005260:Female; D005858:Germany; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D000069451:Long Term Adverse Effects / Q000175:diagnosis / Q000209:etiology; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D012042:Registries; D012307:Risk Factors; D013997:Time Factors; D054457:Tissue Scaffolds / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus
keywords: ACS; Acute coronary syndrome; BVS; Bifurcations; Bioresorbable vascular scaffold; Long-term outcome