Self-expanding nitinol renal artery stents: comparison of safety and efficacy of bare versus polyzene-F nanocoated stents in a porcine model

To investigate the safety and efficacy of a Polyzene-F nanocoat on new low-profile self-expandable nitinol stents in minipig renal arteries.

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Main Authors: Kurz, Patrick (Author) , Stampfl, Ulrike (Author) , Christoph, Patricia (Author) , Henn, C. (Author) , Satzl, Stefanie (Author) , Radeleff, Boris (Author) , Berger, Irina (Author) , Richter, Götz Martin (Author)
Format: Article (Journal)
Language:English
Published: 2011
In: CardioVascular and interventional radiology
Year: 2011, Volume: 34, Pages: 139-148
ISSN:1432-086X
DOI:10.1007/s00270-010-9987-7
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1007/s00270-010-9987-7
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Author Notes:P. Kurz, U. Stampfl, P. Christoph, C. Henn, S. Satzl, B. Radeleff, I. Berger, G.M. Richter
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Summary:To investigate the safety and efficacy of a Polyzene-F nanocoat on new low-profile self-expandable nitinol stents in minipig renal arteries.
Objective: To investigate the safety and efficacy of a Polyzene-F nanocoat on new low-profile self-expandable nitinol stents in minipig renal arteries. Materials and Methods: Ten bare nitinol stents (BNS) and 10 stents coated with a 50 nm-thin Polyzene-F coating were randomly implanted into renal arteries of 10 minipigs (4- and 12-week follow-up, 5 animals/group). Thrombogenicity, on-stent surface endothelialization, vessel wall injury, late in-stent stenosis, and peristrut vessel wall inflammation were determined by quantitative angiography and postmortem histomorphometry. Results: In 6 of 10 BNS, >50% stenosis was found, but no stenosis was found in stents with a nanothin Polyzene-F coating. Histomorphometry showed a statistically significant (p < 0.05) different average maximum luminal loss of 55.16% ± 8.43% at 12 weeks in BNS versus 39.77% ± 7.41% in stents with a nanothin Polyzene-F coating. Stents with a nanothin Polyzene-F coating had a significantly (p < 0.05) lower inflammation score after 12 weeks, 1.31 ± 1.17 versus 2.17 ± 0.85 in BNS. The results for vessel wall injury (0.6 ± 0.58 for Polyzene-F-coated stents; 0.72 ± 0.98 for BNS) and re-endothelialization, (1.16 ± 0.43 and 1.23 ± 0.54, respectively) were not statistically significant at 12-week follow-up. No thrombus deposition was observed on the stents at either follow-up time point. Conclusion: Nitinol stents with a nanothin Polyzene-F coating successfully decreased in-stent stenosis and vessel wall inflammation compared with BNS. Endothelialization and vessel wall injury were found to be equal. These studies warrant long-term pig studies (≥120 days) because 12 weeks may not be sufficient time for complete healing; thereafter, human studies may be warranted.
Item Description:Published online: 26 October 2010
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Physical Description:Online Resource
ISSN:1432-086X
DOI:10.1007/s00270-010-9987-7