Journal
INVESTIGATIVE RADIOLOGY
Volume 42, Issue 5, Pages 303-311Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/01.rli.0000261439.90760.9d
Keywords
vascular stents; late in-stent stenosis; thrombogenicity; biocompatibility; polyphosphazene
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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 mu m, 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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