Clinical outcomes of overlapping versus non-overlapping everolimus-eluting absorb bioresorbable vascular scaffolds: An analysis from the multicentre prospective RAI registry (ClinicalTrials.gov identifier: NCT02298413)

Catheter Cardiovasc Interv. 2018 Jan 1;91(1):E1-E16. doi: 10.1002/ccd.27095. Epub 2017 May 13.

Abstract

Objectives: To compare clinical outcomes of patients treated with overlapping versus non-overlapping Absorb BVS.

Background: Limited data are available on the clinical impact of stent overlap with the Absorb BVS bioresorbable stent.

Methods: We compared outcomes of patients receiving overlapping or non-overlapping Absorb BVS in the multicenter prospective RAI Registry.

Results: Out of 1,505 consecutive patients treated with Absorb BVS, 1,384 were eligible for this analysis. Of these, 377 (27%) were in the overlap group, and 1,007 (73%) in the non-overlap group. The most frequent overlap configuration was the marker-to-marker type (48%), followed by marker-over-marker (46%) and marker-inside-marker (6%) types. Patients of the overlap group had higher prevalence of multivessel disease and higher SYNTAX score, and required more frequently the use of intravascular imaging. At a median follow-up of 368 days, no difference was observed between overlap and non-overlap groups in terms of a device-related composite endpoint (cardiac death, TV-MI, ID-TLR) (5.8% vs. 4.1%, P = 0.20) or of a patient-related composite endpoint (any death, any MI, any revascularization) (15.4% vs. 12.5%, P = 0.18). Cardiac death (1.0% vs. 1.3%, P = 0.54), MI (4.5% vs. 3.6%, P = 0.51), TVR (4.5% vs. 3.6%, P = 0.51) and stent thrombosis (1.1 vs. 1.5%, P = 1.00) were also comparable between groups. When assessing outcomes of the overlap population according to overlap configurations used, no difference was observed in terms of the device- or patient-related composite endpoints.

Conclusions: Outcomes of patients with or without overlapping BVS were comparable at mid-term follow-up despite higher angiographic complexity of the overlap subset. © 2017 Wiley Periodicals, Inc.

Keywords: bioresorbable stents; complex lesions; long lesions; overlap.

Publication types

  • Comparative Study
  • Multicenter Study

MeSH terms

  • Absorbable Implants*
  • Aged
  • Cardiovascular Agents / administration & dosage*
  • Cardiovascular Agents / adverse effects
  • Coated Materials, Biocompatible*
  • Coronary Angiography
  • Everolimus / administration & dosage*
  • Everolimus / adverse effects
  • Female
  • Humans
  • Italy
  • Male
  • Middle Aged
  • Myocardial Ischemia / diagnosis
  • Myocardial Ischemia / mortality
  • Myocardial Ischemia / surgery*
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Percutaneous Coronary Intervention / mortality
  • Prospective Studies
  • Prosthesis Design
  • Recurrence
  • Registries
  • Risk Factors
  • Time Factors
  • Tomography, Optical Coherence
  • Treatment Outcome
  • Ultrasonography, Interventional

Substances

  • Cardiovascular Agents
  • Coated Materials, Biocompatible
  • Everolimus