Assessment of the absorption process following bioabsorbable everolimus-eluting stent implantation: temporal changes in strain values and tissue composition using intravascular ultrasound radiofrequency data analysis. A substudy of the ABSORB clinical trial

EuroIntervention. 2009 Jan;4(4):443-8. doi: 10.4244/eijv4i4a77.

Abstract

Aims: The main objective was to use IVUS-backscatter radiofrequency (IVUS-RF) to assess the degradation of a bioabsorbable stent by measuring serial changes in dense calcium (DC) and necrotic core (NC) as assessed by intravascular ultrasound-Virtual Histology (IVUS-VH) and in the strain as assessed by palpography.

Methods and results: In the ABSORB trial, 27 patients treated with a single bioabsorbable everolimus-eluting stent (BVS, Abbott Vascular, Santa Clara, CA, USA) were all imaged with IVUS-RF post-stenting and at 6-month follow-up, and 13 and 12 patients were also investigated pre-stenting with IVUS-VH and palpography respectively. From pre- to post-stenting, with VH (n = 13), there was an increase in mean "DC" (9.8 vs. 25.4%, p = 0.0002) and "NC" (15.5 vs. 30.5%, p = 0.0002). In palpography (n = 12), the mean number of frames with Rotterdam Classification (ROC) III/IV per cm decreased from 1.22 +/- 1.91 to 0.12 +/- 0.31 (p = 0.0781) and the mean cumulative strain values (all frames with ROC I-IV scores) changed from 0.50 +/- 0.27 to 0.20 +/- 0.10% (p = 0.0034). Comparing post-stenting with follow-up (n = 27), VH showed a decrease in "DC" (29.7% vs. 21.1%, p = 0.0001). "NC" also decreased (26.9 vs. 21.5%, p = 0.0027). For palpography (n = 25 patients), an increase in the mean number of frames with ROC III/IV per cm was observed from 0.09 +/- 0.26 to 0.22 +/- 0.36 (p = -0.1563) while the mean cumulative strain values (all frames with ROC I-IV scores) changed from 0.15 +/- 0.10 to 0.26 +/- 0.12% (p < 0.0001).

Conclusions: IVUS-VH changes at 6 months suggest alteration of the BVS with reduction of RF backscattering by polymeric struts. Strained plaques on the palpograms were almost abolished following stent implantation. However, strain values reappeared within 6 months suggesting an increase in endoluminal deformability of the stented vessel.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Absorbable Implants*
  • Aged
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Calcinosis / diagnostic imaging
  • Calcinosis / therapy
  • Cardiovascular Agents / administration & dosage*
  • Coronary Artery Disease / diagnostic imaging*
  • Coronary Artery Disease / therapy*
  • Drug-Eluting Stents*
  • Europe
  • Everolimus
  • Female
  • Humans
  • Male
  • Middle Aged
  • Necrosis
  • New Zealand
  • Prospective Studies
  • Prosthesis Design
  • Sirolimus / administration & dosage
  • Sirolimus / analogs & derivatives*
  • Stress, Mechanical
  • Time Factors
  • Treatment Outcome
  • Ultrasonography, Interventional* / instrumentation
  • User-Computer Interface

Substances

  • Cardiovascular Agents
  • Everolimus
  • Sirolimus