Comparison between the first and second generation bioresorbable vascular scaffolds: a six month virtual histology study

EuroIntervention. 2011 Apr;6(9):1110-6. doi: 10.4244/EIJV6I9A193.

Abstract

Aims: To compare the intravascular ultrasound virtual histology (IVUS-VH) appearance of the polymeric struts of the first (Revision 1.0) and the second (Revision 1.1) generation bioresorbable vascular scaffold (BVS).

Methods and results: IVUS-VH misrepresents polymeric struts as dense calcium (DC) and necrotic core (NC) so that their presence and disappearance could be used as potential artifactual surrogate of bioresorption. DC and NC were assessed in both revisions of the BVS by analysing IVUS-VH from all patients in the ABSORB cohort A (Revision 1.0) and cohort B (Revision 1.1) study who had an IVUS-VH post-treatment and at 6-month follow-up. Post-treatment and 6-month follow-up IVUS-VH results, available in 60 patients (BVS 1.0 n=28; BVS 1.1 n=32), indicated an insignificant rise in DC+NC area compared to baseline with Revision 1.1 (0.10 ± 0.46 mm2, p=0.2), whilst a significant reduction was seen with Revision 1.0 (-0.57 ± 1.3 mm2, p=0.02). A significant correlation has been found between the change in the DC+NC area and the change in external elastic membrane area (y=0.68x-0.1; r=0.58, p=0.03).

Conclusions: Based on 6-months IVUS-VH analysis, the BVS 1.1 appears to have a different backscattering signal compared to the BVS 1.0, which may reflect differences in the speed of chemical and structural alteration.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Absorbable Implants*
  • Aged
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Australia
  • Calcinosis / diagnostic imaging
  • Cardiovascular Agents / therapeutic use
  • Coronary Angiography
  • Coronary Stenosis / diagnostic imaging
  • Coronary Stenosis / therapy*
  • Coronary Vessels / diagnostic imaging*
  • Drug-Eluting Stents*
  • Europe
  • Everolimus
  • Female
  • Humans
  • Image Interpretation, Computer-Assisted
  • Male
  • Middle Aged
  • Necrosis
  • New Zealand
  • Polyesters
  • Prosthesis Design
  • Sirolimus / administration & dosage
  • Sirolimus / analogs & derivatives
  • Time Factors
  • Tissue Scaffolds*
  • Treatment Outcome
  • Ultrasonography, Interventional*

Substances

  • Cardiovascular Agents
  • Polyesters
  • poly(lactide)
  • Everolimus
  • Sirolimus