Bioresorbable vascular scaffolds versus everolimus-eluting metallic stents in patients with ST-segment elevation myocardial infarction: 5-year results of the BVS-EXAMINATION study

EuroIntervention. 2020 Mar 20;15(16):1436-1443. doi: 10.4244/EIJ-D-19-00773.

Abstract

Aims: The aim of this study was to compare five-year clinical outcomes between an everolimus-eluting bioresorbable scaffold (BRS) and an everolimus-eluting metallic stent (EES) in STEMI patients.

Methods and results: This observational and retrospective study included 235 consecutive STEMI patients treated with BRS, compared with 235 STEMI patients treated with EES from the EXAMINATION trial, by applying propensity score matching. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction and target lesion revascularisation at five-year follow-up. Device thrombosis, according to the ARC criteria, was also evaluated. Optical coherence tomography (OCT) analysis was also performed at five years in event-free BRS patients. The cumulative incidence of five-year DOCE was higher in the BRS group as compared to the EES group (13.2% vs 7.6%, HR 1.87, 95% CI: 0.94-3.44, p=0.071), mainly driven by a higher rate of TLR (7.6% vs 1.7%, HR 1.15, 95% CI: 0.44-2.30, p=0.004). The five-year definite BRS thrombosis rate was also higher as compared to EES (4.2% vs 1.2%, HR 3.49, 95% CI: 0.95-12.82, p=0.054). OCT analysis showed a high incidence of neoatherosclerosis in the BRS group.

Conclusions: The five-year event risk was higher with BRS versus EES in STEMI. This suggests that the probability of obtaining favourable results at very long-term follow-up is low. Whether better results will be obtained with new-generation BVS remains to be determined.

Publication types

  • Comparative Study
  • Observational Study

MeSH terms

  • Absorbable Implants*
  • Aged
  • Aged, 80 and over
  • Cardiovascular Agents / administration & dosage*
  • Drug-Eluting Stents*
  • Everolimus / administration & dosage*
  • Female
  • Humans
  • Male
  • Metals*
  • Myocardial Infarction / diagnosis
  • Myocardial Infarction / mortality
  • Myocardial Infarction / therapy*
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Percutaneous Coronary Intervention / mortality
  • Prosthesis Design
  • Retrospective Studies
  • ST Elevation Myocardial Infarction / surgery*
  • Sirolimus / administration & dosage*
  • Stents
  • Time Factors
  • Tissue Scaffolds*
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Metals
  • Everolimus
  • Sirolimus