Restenosis of the CYPHER-Select, TAXUS-Express, and Polyzene-F nanocoated cobalt-chromium stents in the minipig coronary artery model

Cardiovasc Intervent Radiol. 2008 Sep-Oct;31(5):971-80. doi: 10.1007/s00270-007-9243-y. Epub 2007 Dec 19.

Abstract

Purpose: To date no direct experimental comparison between the CYPHER-Select and TAXUS-Express stents is available. Therefore, we investigated late in-stent stenosis, thrombogenicity, and inflammation, comparing the CYPHER-Select, TAXUS-Express, and custom-made cobalt chromium Polyzene-F nanocoated stents (CCPS) in the minipig coronary artery model.

Methods: The three stent types were implanted in the right coronary artery of 30 minipigs. The primary endpoint was in-stent stenosis assessed by quantitative angiography and microscopy. Secondary endpoints were inflammation and thrombogenicity evaluated by scores for inflammation and immunoreactivity (C-reactive protein and transforming growth factor beta). Follow-up was at 4 and 12 weeks.

Results: Stent placement was successful in all animals; no thrombus deposition occurred. Quantitative angiography did not depict statistically significant differences between the three stent types after 4 and 12 weeks. Quantitative microscopy at 4 weeks showed a statistically significant thicker neointima (p = 0.0431) for the CYPHER (105.034 +/- 62.52 microm) versus the TAXUS (74.864 +/- 66.03 microm) and versus the CCPS (63.542 +/- 39.57 microm). At 12 weeks there were no statistically significant differences. Inflammation scores at 4 weeks were significantly lower for the CCPS and CYPHER compared with the TAXUS stent (p = 0.0431). After 12 weeks statistical significance was only found for the CYPHER versus the TAXUS stent (p = 0.0431). The semiquantitative immunoreactivity scores for C-reactive protein and transforming growth factor beta showed no statistically significant differences between the three stent types after 4 and 12 weeks.

Conclusions: The CCPS provided effective control of late in-stent stenosis and thrombogenicity in this porcine model compared with the two drug-eluting stents. Its low inflammation score underscores its noninflammatory potential and might explain its equivalence to the two DES.

Publication types

  • Comparative Study

MeSH terms

  • Angioplasty, Balloon, Coronary / instrumentation
  • Angioplasty, Balloon, Coronary / methods
  • Animals
  • Biopsy, Needle
  • Blood Vessel Prosthesis
  • Chromium / pharmacology
  • Coated Materials, Biocompatible
  • Cobalt / pharmacology
  • Coronary Disease / pathology
  • Coronary Disease / therapy*
  • Coronary Restenosis / pathology*
  • Disease Models, Animal
  • Drug-Eluting Stents*
  • Female
  • Immunohistochemistry
  • Nanocomposites
  • Polymers*
  • Probability
  • Prosthesis Design
  • Prosthesis Failure*
  • Random Allocation
  • Sensitivity and Specificity
  • Sirolimus / therapeutic use
  • Swine
  • Swine, Miniature
  • Tacrolimus

Substances

  • Coated Materials, Biocompatible
  • Polymers
  • Chromium
  • Cobalt
  • Sirolimus
  • Tacrolimus