Impact of overlapping on 1-year clinical outcomes in patients undergoing everolimus-eluting bioresorbable scaffolds implantation in routine clinical practice: Insights from the European multicenter GHOST-EU registry

Catheter Cardiovasc Interv. 2017 Apr;89(5):812-818. doi: 10.1002/ccd.26674. Epub 2016 Aug 12.

Abstract

Background: Overlapping implantation of bioresorbable scaffolds (BRSs) are frequent in long coronary lesions. Its impact on clinical outcomes is unknown.

Objective: To compare the clinical outcomes of patients treated with overlapping BRS with those patients treated with no-overlap BRS.

Methods: We analyzed the 1-year clinical outcomes of 1,477 patients treated with BRS in the GHOST-EU registry, according to the implantation of overlapping BRS. Primary endpoint was patient oriented composite endpoint (PoCE) of: all-cause death, any myocardial infarction (MI) and any repeated revascularization. Scaffold thrombosis, according to Academic Research Consortium definition, was also analyzed.

Results: A total of 320 (21.7%) patients were treated with overlapping BRS (overlap group), whereas the remaining 1,157 (78.3%) received no-overlap BRS (no-overlap group). The overlap group had significantly higher frequency of male sex, diabetes mellitus, stable angina, B2/C lesion type, SYNTAX score ≥22, lesion length >34 mm, use of intracoronary imaging guidance, pre- and postdilatation. At 1-year, there were no differences in PoCE between the overlap versus no-overlap group (18.4% vs. 18.2%; HR 1.07, [0.80-1.44]; P = 0.636), even after adjustment (HR 1.05, [0.48-2.20]; P = 0.904). Scaffold thrombosis rate did not differ either at one-month (1.3% vs. 1.5%, P = 0.769) or at 1-year (1.9% vs. 2.1%, P = 0.823).

Conclusions: In "Real-world" clinical practice, overlapping BRS does not appear to have an impact on clinical outcomes as compared to no-overlapping BRS. These preliminary data should be confirmed. © 2016 Wiley Periodicals, Inc.

Keywords: bioresorbable scaffolds; bioresorbable vascular scaffolds; coronary artery disease; percutaneous coronary intervention.

Publication types

  • Multicenter Study

MeSH terms

  • Absorbable Implants*
  • Coronary Artery Disease / diagnosis
  • Coronary Artery Disease / surgery*
  • Drug-Eluting Stents*
  • Europe / epidemiology
  • Everolimus / pharmacology*
  • Female
  • Follow-Up Studies
  • Humans
  • Immunosuppressive Agents / pharmacology
  • Incidence
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention / methods*
  • Postoperative Complications / epidemiology
  • Prosthesis Design
  • Registries*
  • Retrospective Studies
  • Survival Rate / trends
  • Time Factors
  • Tissue Scaffolds*

Substances

  • Immunosuppressive Agents
  • Everolimus