Abstract 13587: Vascular Effects of Paclitaxel Following Drug-Eluting Balloon Angioplasty in a Porcine Coronary Model: The Importance of Excipients
Background: The vascular effects of drug- eluting balloon (DEB) deployment in the absence of coronary stents have not been characterized. This study evaluated the potential of different excipients to facilitate paclitaxel transfer to the arterial wall in the absence of additional stents.
Methods: A total 45 porcine arteries were treated with paclitaxel coated DEBs using four different excipients (all 3.0 μ g/mm2): A) iopromide (n=9), B) ATEC [acetyltriethyl citrate] excipient (n=8), C) BTHC [n-butyryl-tri-n-hexylcitrate] excipient (n=10), D) lecithine excipient (n=10). Uncoated bare angioplasty balloons served as controls (n=8). Histology, histomorphometry, and quantitative angiography analysis were performed 28 days following intervention. Tissue concentrations of paclitaxel were measured in selected animals (n=39 arteries).
Results: Treatment with DEBs using BTHC excipient or iopromide was associated with increased fibrin deposition and inflammation indicating delayed vascular healing. In contrast, treatment with DEBs using lecithin excipient or uncoated angioplasty balloons did not induce any comparable vascular effects.
Conclusions: Effective excipients are necessary to accomplish successful balloon facilitated paclitaxel delivery, which is associated with delayed vascular healing as a sign of successful drug transfer.
- © 2011 by American Heart Association, Inc.