Document Detail

Optimization of drug-eluting balloon use for safety and efficacy: evaluation of the 2nd generation paclitaxel-eluting DIOR-balloon in porcine coronary arteries.
MedLine Citation:
PMID:  20839356     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: The aim of this preclinical study was to optimize the use of drug-eluting balloon (DEB) DIOR(2nd) (generation) by measurements of tissue and plasma paclitaxel concentrations in porcine coronary artery overstretch and prove efficacy in inhibition of neointimal growth without complementary use of stent.
BACKGROUND: The usually recommended DEB 60 sec inflation time causes prolonged ischemia and arterial injury.
METHODS: Tissue, plasma, and balloon surface concentrations of paclitaxel were measured in pigs 45 min and 12 hr after balloon inflation times of 15, 20, 30, 45, and 60 sec. Extent of neointimal hyperplasia was compared using DIOR(2nd) (generation) or noncoated balloon at two-week follow-up. Paclitaxel was replaced by fluorescent paclitaxel derivative in DEB and DES to demonstrate the distribution of the drug in arterial wall.
RESULTS: DIOR(2nd) (generation) DEB provided 29 ± 3 μM/L, 52 ± 6 μM/L, 196 ± 44 μM/L, 202 ± 36 μM/L, and 184 ± 59 μM/L paclitaxel to the vessel wall after 15, 20, 30, 45, and 60 sec of dilation, reaching plateau at 30 sec inflation time. Paclitaxel penetrated up to 2 mm tissue deepness. Measurable plasma paclitaxel level (45 ± 28 ng/mL) was found only after 60 sec balloon inflation time. At follow-up, the dilated arterial segment neointimal area and maximal neointimal thickness were significantly smaller with DIOR vs. uncoated balloon use. Fluorescence images of DIOR showed a homogenous distribution of the drug on the vessel, in contrast with DES.
CONCLUSION: Using the DIOR(2nd) (generation) DEB, a maximal balloon inflation time of 30-45 sec is optimal, reducing effectively the neointimal hyperplasia.
Anikó Pósa; Noemi Nyolczas; Rayyan Hemetsberger; Noemi Pavo; Ors Petnehazy; Zsolt Petrasi; Giuseppe Sangiorgi; Mariann Gyöngyösi
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Publication Detail:
Type:  Evaluation Studies; Journal Article    
Journal Detail:
Title:  Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions     Volume:  76     ISSN:  1522-726X     ISO Abbreviation:  Catheter Cardiovasc Interv     Publication Date:  2010 Sep 
Date Detail:
Created Date:  2010-09-14     Completed Date:  2011-01-14     Revised Date:  2014-07-30    
Medline Journal Info:
Nlm Unique ID:  100884139     Medline TA:  Catheter Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  395-403     Citation Subset:  IM    
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MeSH Terms
Angioplasty, Balloon, Coronary / adverse effects,  instrumentation*
Cardiovascular Agents / administration & dosage*,  blood,  pharmacokinetics
Cell Proliferation / drug effects
Coronary Vessels / drug effects*,  metabolism,  pathology
Equipment Design
Materials Testing
Microscopy, Fluorescence
Models, Animal
Paclitaxel / administration & dosage*,  blood,  pharmacokinetics
Sus scrofa
Tissue Distribution
Tunica Intima / drug effects*,  metabolism,  pathology
Reg. No./Substance:
0/Cardiovascular Agents; 33069-62-4/Paclitaxel

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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