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Self-expanding nitinol renal artery stents: comparison of safety and efficacy of bare versus Polyzene-F nanocoated stents in a porcine model.
MedLine Citation:
PMID:  20976452     Owner:  NLM     Status:  In-Process    
Abstract/OtherAbstract:
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.
Authors:
P Kurz; U Stampfl; P Christoph; C Henn; S Satzl; B Radeleff; I Berger; G M Richter
Publication Detail:
Type:  Journal Article     Date:  2010-10-26
Journal Detail:
Title:  Cardiovascular and interventional radiology     Volume:  34     ISSN:  1432-086X     ISO Abbreviation:  Cardiovasc Intervent Radiol     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-01-13     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8003538     Medline TA:  Cardiovasc Intervent Radiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  139-48     Citation Subset:  IM    
Affiliation:
Clinics for Diagnostic and Interventional Radiology, Klinikum Stuttgart, Kriegsbergstr. 60, 70174, Stuttgart, Germany.
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