Document Detail


Polymer-free Paclitaxel-coated Zilver PTX Stents-Evaluation of Pharmacokinetics and Comparative Safety in Porcine Arteries.
MedLine Citation:
PMID:  21419649     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
PURPOSE: To evaluate the pharmacokinetics and safety of the Zilver PTX Drug-Eluting Stent (Cook Medical, Bloomington, Indiana) in a normal porcine artery model. MATERIALS AND METHODS: Pharmacokinetic analyses were performed using 18 pigs, each implanted with four paclitaxel-coated stents. Paclitaxel remaining on the stents, delivered locally (to artery wall), regionally (to adjacent and downstream muscle), and systemically (to plasma), was determined at various times through 56 days. For safety evaluation, local, regional, and systemic responses were grossly and histologically assessed at 1 month, 3 months, and 6 months in 21 additional pigs and compared with the responses to bare metal stents in 21 separate pigs. RESULTS: Stents delivered approximately 95% of the total paclitaxel within 24 hours after deployment. Nonetheless, there were sustained paclitaxel levels in the artery wall through 56 days, maintained at approximately 20% of the peak level through 14 days. Very little paclitaxel was distributed regionally or systemically, becoming undetectable in plasma at 10 hours. Complete necropsy, hematology, and serum chemistry revealed no adverse effects associated with the paclitaxel-coated stents. Within 3 months, vessels with both paclitaxel-coated and bare metal stents showed comparable, complete healing. CONCLUSIONS: The Zilver PTX stent appears to be safe, achieves sustained paclitaxel levels in the artery wall, and shows complete vessel healing comparable to bare metal stents within 3 months.
Authors:
Michael D Dake; William G Van Alstine; Qing Zhou; Anthony O Ragheb
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-3-16
Journal Detail:
Title:  Journal of vascular and interventional radiology : JVIR     Volume:  -     ISSN:  1535-7732     ISO Abbreviation:  -     Publication Date:  2011 Mar 
Date Detail:
Created Date:  2011-3-22     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9203369     Medline TA:  J Vasc Interv Radiol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011 SIR. Published by Elsevier Inc. All rights reserved.
Affiliation:
Department of Cardiothoracic Surgery, Stanford University School of Medicine, Falk Cardiovascular Research Center, Stanford, California.
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