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Biological effect on drug distribution and vascular healing via paclitaxel-coated balloon technology in drug eluting stent restenosis swine model.
- Source :
-
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions [Catheter Cardiovasc Interv] 2016 Jul; Vol. 88 (1), pp. 89-98. Date of Electronic Publication: 2015 Nov 28. - Publication Year :
- 2016
-
Abstract
- Objectives: To evaluate the biological effect of a paclitaxel-coated balloon (PCB) technology on vascular drug distribution and healing in drug eluting stent restenosis (DES-ISR) swine model.<br />Background: The mechanism of action and healing response via PCB technology in DES-ISR is not completely understood.<br />Methods: A total of 27 bare metal stents were implanted in coronary arteries and 30 days later the in-stent restenosis was treated with PCB. Treated segments were harvested at 1 hr, 14 days and 30 days post treatment for the pharmacokinetic analysis. In addition, 24 DES were implanted in coronary arteries for 30 days, then all DES-ISRs were treated with either PCB (n = 12) or uncoated balloon (n = 12). At day 60, vessels were harvested for histology following angiography and optical coherence tomography (OCT).<br />Results: The paclitaxel level in neointimal tissue was about 18 times higher (P = 0.0004) at 1 hr Cmax , and retained about five times higher (P = 0.008) at day 60 than that in vessel wall. A homogenous distribution of paclitaxel in ISR was demonstrated by using fluorescently labeled paclitaxel. Notably, in DES-ISR, both termination OCT and quantitative coronary angioplasty showed a significant neointimal reduction and less late lumen loss (P = 0.05 and P = 0.03, respectively) post PCB versus post uncoated balloon. The PES-ISR + PCB group displayed higher levels of peri-strut inflammation and fibrin scores compared to the -limus DES-ISR + PCB group.<br />Conclusions: In ISR, paclitaxel is primarily deposited in neointimal tissue and effectively retained over time following PCB use. Despite the presence of metallic struts, a uniform distribution was characterized. PCB demonstrated an equivalent biological effect in DES-ISR without significantly increasing inflammation. © 2015 Wiley Periodicals, Inc.<br /> (© 2015 Wiley Periodicals, Inc.)
- Subjects :
- Animals
Cardiovascular Agents pharmacokinetics
Coronary Angiography
Coronary Restenosis diagnostic imaging
Coronary Restenosis etiology
Coronary Restenosis metabolism
Coronary Vessels diagnostic imaging
Coronary Vessels metabolism
Disease Models, Animal
Equipment and Supplies
Fibrin metabolism
Metals
Neointima
Paclitaxel pharmacokinetics
Percutaneous Coronary Intervention adverse effects
Swine
Tissue Distribution
Tomography, Optical Coherence
Cardiac Catheterization instrumentation
Cardiac Catheters
Cardiovascular Agents administration & dosage
Coated Materials, Biocompatible
Coronary Restenosis therapy
Coronary Vessels drug effects
Paclitaxel administration & dosage
Percutaneous Coronary Intervention instrumentation
Stents
Wound Healing drug effects
Subjects
Details
- Language :
- English
- ISSN :
- 1522-726X
- Volume :
- 88
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
- Publication Type :
- Academic Journal
- Accession number :
- 26613810
- Full Text :
- https://doi.org/10.1002/ccd.26278