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Preclinical evaluation of a novel drug-eluting balloon in an animal model of in-stent stenosis.
MedLine Citation:
PMID:  22262578     Owner:  NLM     Status:  Publisher    
Despite advances in contemporary stent technology, in-stent restenosis (ISR) remains the major limitation following revascularization procedures. We developed a porcine model of ISR to specifically investigate the preclinical outcomes of a novel drug-eluting balloon (DEB) in this particular setting. Fifteen pigs received bare metal stents in each of the major coronary arteries for 28 days to induce neointimal growth. Following repeat angiography, animals were allocated to fourdifferent treatment groups. The control group consisted of a bare angioplasty catheter, while the Pantera Lux(TM), cursive (3.0 µg/mm(2) paclitaxel) (30 s inflation) was compared to two consecutive deployments of the Pantera Lux(TM), cursive (60 s inflation each) and the commercial SeQuent® Please balloon (60 s inflation). Twenty-eight days following balloon deployment, the animals underwent repeat angiography and were subsequently sacrificed for histopathologic assessment. There was a trend in reduction of percent diameter stenosis in the DEB group versus control (13.9% vs. 20.4%), while longer inflation duration or consecutive DEB deployment had no additional growth-limiting effect. Neointimal thickness was reduced from 0.38 ± 0.13 to 0.30 ± 0.09 mm in the control versus DEB group. All DEB groups showed delayed vascular healing characterized by dose-dependent increases in fibrin deposition and neointimal cell vacuity. Investigation of DEB in a porcine model of ISR is feasible and more accurately represents human disease conditions. The magnitude of neointima suppression is lower than that observed in non-diseased animal models and is accompanied by delayed vascular healing.
Michael Joner; Peter W Radke; Robert A Byrne; Sonja Hartwig; Kristin Steigerwald; Guy Leclerc; Eric Wittchow
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-1-19
Journal Detail:
Title:  Journal of biomaterials applications     Volume:  -     ISSN:  1530-8022     ISO Abbreviation:  -     Publication Date:  2012 Jan 
Date Detail:
Created Date:  2012-1-20     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8813912     Medline TA:  J Biomater Appl     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Deutsches Herzzentrum München, Klinik an der Technischen Universität München, München, Germany.
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