Self-Expanding Nitinol Renal Artery Stents: Comparison of Safety and Efficacy of Bare Versus Polyzene-F Nanocoated Stents in a Porcine Model

Journal Article · Tue Feb 15 00:00:00 EST 2011 · Cardiovascular and Interventional Radiology

DOI:https://doi.org/10.1007/S00270-010-9987-7· OSTI ID:21608808

Kurz, P ^[1]; Stampfl, U; Christoph, P; Henn, C; Satzl, S; Radeleff, B ^[2]; Berger, I ^[3]

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1. Klinikum Stuttgart, Clinics for Diagnostic and Interventional Radiology (Germany)
2. University of Heidelberg, Department of Diagnostic and Interventional Radiology (Germany)
3. Institute of General Pathology (Germany)

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.

• OSTI ID: 21608808
• Journal Information: Cardiovascular and Interventional Radiology, Vol. 34, Issue 1; Conference: BSIR 2010: Annual meeting of the British Society of Interventional Radiology, Liverpool (United Kingdom), 3-5 Nov 2010; Other Information: DOI: 10.1007/s00270-010-9987-7; Copyright (c) 2011 Springer Science+Business Media, LLC and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE); Country of input: International Atomic Energy Agency (IAEA); ISSN 0174-1551
• Country of Publication: United States
• Language: English

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