Late Stent Recoil of the Bioabsorbable Everolimus-Eluting Coronary Stent and Its Relationship With Plaque Morphology

J Am Coll Cardiol. 2008 Nov 11;52(20):1616-20. doi: 10.1016/j.jacc.2008.08.024.

Abstract

Objectives: This study sought to evaluate late recoil of a novel bioabsorbable everolimus-eluting coronary stent (BVS), which is composed of a poly-L-lactic acid backbone, coated with a bioabsorbable polymer containing everolimus.

Background: Little is known about the mechanical behavior of bioabsorbable polymer stents after deployment in diseased human coronary arteries.

Methods: The study population consisted of 16 patients, who were treated with elective BVS implantation for single de novo native coronary artery lesions and were followed at 6 months. All patients underwent an intravascular ultrasound examination at post-procedure and follow-up. A total of 484 paired cross-sectional areas (CSAs) were acquired and analyzed. Late absolute stent recoil was defined as stent area at post-procedure (X) - stent area at follow-up (Y). Late percent stent recoil was defined as (X - Y)/X x 100. In each CSA, plaque morphology was assessed qualitatively and classified as calcific, fibronecrotic, or fibrocellular plaque.

Results: Late absolute and percent recoil of the BVS was 0.65 +/- 1.71 mm(2) (95% confidence interval [CI]: 0.49 to 0.80 mm(2)) and 7.60 +/- 23.3% (95% CI: 5.52% to 9.68%). Calcified plaques resulted in significantly less late recoil (0.20 +/- 1.54 mm(2) and 1.97 +/- 22.2%) than fibronecrotic plaques (1.03 +/- 2.12 mm(2) and 12.4 +/- 28.0%, p = 0.001 and p = 0.001, respectively) or fibrocellular plaque (0.74 +/- 1.48 mm(2) and 8.90 +/- 19.8%, p = 0.001 and p = 0.001, respectively).

Conclusions: The BVS shrank in size during the follow-up period. The lesion morphology of stented segments might affect the degree of late recoil of the BVS. (ABSORB Everolimus Eluting Coronary Stent System First in Man Clinical Investigation; NCT00300131).

MeSH terms

  • Aged
  • Biocompatible Materials / chemistry
  • Coronary Artery Disease / pathology
  • Coronary Artery Disease / therapy*
  • Coronary Vessels / pathology*
  • Drug-Eluting Stents*
  • Everolimus
  • Female
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Lactic Acid / chemistry
  • Male
  • Middle Aged
  • Polyesters
  • Polymers / chemistry
  • Sirolimus / administration & dosage
  • Sirolimus / analogs & derivatives
  • Time Factors

Substances

  • Biocompatible Materials
  • Immunosuppressive Agents
  • Polyesters
  • Polymers
  • Lactic Acid
  • poly(lactide)
  • Everolimus
  • Sirolimus

Associated data

  • ClinicalTrials.gov/NCT00300131