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

Satzl, Stefanie; Henn, Christina; Christoph, Patricia; Kurz, Patrick; Stampfl, Ulrike; Stampfl, Sibylle; Thomas, Florian; Radeleff, Boris; Berger, Irina; Grunze, Michael; Richter, Götz M.

doi:10.1097/01.rli.0000261439.90760.9d

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

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Grunze, Michael
Cellular Biophysics, Max Planck Institute for Medical Research, Max Planck Society;

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Citation

Satzl, S., Henn, C., Christoph, P., Kurz, P., Stampfl, U., Stampfl, S., et al. (2007). The efficacy of nanoscale poly[bis(trifluoroethoxy) phosphazene] (PTFEP) coatings in reducing thrombogenicity and late in-stent stenosis in a porcine coronary artery model. Investigative Radiology, 42(5), 303-311. doi:10.1097/01.rli.0000261439.90760.9d.

Cite as: https://hdl.handle.net/21.11116/0000-0001-9E18-3

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.