The efficacy of nanoscale poly[bis(trifluoroethoxy) phosphazene] (PTFEP) coatings in reducing thrombogenicity and late in-stent stenosis in a porcine coronary artery model.

Abstract

OBJECTIVES:

Previous experimental studies have demonstrated that poly[bis(trifluoroethoxy)phosphazene] (PTFEP) nanocoated stents have antithrombotic characteristics, reduce in-stent stenosis, prevent wall inflammation, and do not hamper endothelialization. This study was designed to validate these findings in a porcine coronary artery model.

MATERIALS AND METHODS:

PTFEP-coated (n = 15) and bare stents (n= 13) were implanted in coronary arteries of 18 mini-pigs (4- and 12-week follow-up). Primary study endpoints were thrombogenicity and in-stent stenosis, secondary study endpoints were inflammatory response and re-endothelialization evaluated by quantitative angiography and light microscopy.

RESULTS:

No thrombus deposition occurred on any stent. At 4 weeks follow-up, the bare stents (n = 4) had a significantly smaller neointimal area (1.93 vs. 3.20 mm(2), P = 0.009). At 12 weeks, PTFEP-coated stents (n = 11) had significantly superior results in almost all parameters: neointimal area (2.25 vs. 2.65 mm(2), P = 0.034), neointimal height (204.46 vs. 299.41 microm, P = 0.048), percentage stenosis (38.25 vs. 50.42%, P = 0.019), and inflammation score (0.12 vs. 0.30, P = 0.029). Complete re-endothelialization was seen in both stent types at both intervals.

CONCLUSION:

At long-term follow-up, the superior results of PTFEP-coated stents were characterized by a noteworthy reduction of neointimal growth and inflammatory response.

• Authors: Stefanie Satzl, Christina Henn, Patricia Christoph, Patrick Kurz, Ulrike Stampfl, Sibylle Stampfl, Florian Thomas, Boris Radeleff, Irina Berger, Michael Grunze, Goetz M Richter
• Journal: Investigative radiology (Invest Radiol) Vol. 42 Issue 5 Pg. 303-11 (May 2007) ISSN: 0020-9996 [Print] United States
• PMID: 17414526 (Publication Type: Journal Article)

Chemical References

• Coated Materials, Biocompatible
• Organophosphorus Compounds
• Polymers
• Stainless Steel
• poly(bis(trifluoroethoxy)phosphazene)

Topics

• Animals
• Coated Materials, Biocompatible
• Coronary Angiography
• Coronary Vessels (pathology)
• Models, Animal
• Organophosphorus Compounds
• Polymers
• Prosthesis Design
• Stainless Steel
• Stents
• Swine
• Swine, Miniature
• Thrombosis (prevention & control)
• Tunica Intima (pathology)
• Vascular Patency