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. 2007 May;42(5):303-11.
doi: 10.1097/01.rli.0000261439.90760.9d.

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

Stefanie Satzl  1 , Christina Henn, Patricia Christoph, Patrick Kurz, Ulrike Stampfl, Sibylle Stampfl, Florian Thomas, Boris Radeleff, Irina Berger, Michael Grunze, Goetz M Richter
Affiliations

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

Stefanie Satzl et al. Invest Radiol. 2007 May.

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.

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