Abstract
Here we investigated how a coating of intravascular balloon with paclitaxel (drug-coated balloon; DCB, Freeway™) impacted porcine peripheral artery vascular function and remodeling. Domestic swine (n = 54) underwent percutaneous overstretch balloon dilation of femoral and iliac arteries, controlled by angiography and optical coherence tomography (OCT). Paclitaxel tissue uptake was measured at 1 h and 1, 3, and 9 days post-dilation. At these time-points and at 32 ± 2 days, vascular function of the dilated arteries was assessed using the organ chamber model. Neointimal growth and remodeling indices were determined using OCT and histology at 32 ± 2 days. Intima and media fibrosis were quantified by picrosirius red staining. Post-inflation femoral artery tissue drug levels were 460 ± 214, 136 ± 123, 14 ± 6, and 0.1 ± 0.1 ng/mg at 1 h and 1, 3, and 9 days, respectively. Compared to plain balloon, Freeway™ resulted in a significantly smaller neointimal area (P < 0.05), less tunica intima (8.0 ± 5.4 vs 14.2 ± 4.7 %) and media fibrosis (15.6 ± 7.7 vs 24.5 ± 5.4 %), and less femoral artery constrictive remodeling (remodeling index: 1.08 ± 0.08 vs 0.94 ± 0.08). The DCB was associated with significantly increased vasoconstrictor tone and endothelium-dependent vasodilation impairment shortly after post-overstretch injury. Overall, DCB dilation of peripheral arteries resulted in high drug uptake into arterial tissue. Compared with the plain balloon, the DCB was associated with decreased vessel wall fibrosis after balloon overstretch injury, and reduced degrees of constrictive remodeling and neointimal hyperplasia.Electronic supplementary materialThe online version of this article (doi:10.1007/s10856-016-5737-y) contains supplementary material, which is available to authorized users.
Highlights
As treatment for atherosclerotic peripheral artery disease, percutaneous transluminal angioplasty shows limited success due to high restenosis rates [1,2,3], with 1-year patency rates of 75–85 % after bare-metal stent (BMS) placement [4,5,6]
In the Zilver PTX randomized study of patients with peripheral artery disease, implantation of polymer-free drug-eluting stents (DES) led to improved 12-month results compared to balloon dilation, with similar superiority results when balloon dilation was followed by provisional DES stenting [8]
We report that arterial dilation with the drug-coated balloons (DCBs) FreewayTM inhibited fibrin accumulation in the tunica intima and media of the femoral arteries, leading to significantly less constrictive remodeling of the injured vessel
Summary
As treatment for atherosclerotic peripheral artery disease, percutaneous transluminal angioplasty shows limited success due to high restenosis rates [1,2,3], with 1-year patency rates of 75–85 % after bare-metal stent (BMS) placement [4,5,6]. Studies testing the implantation of drug-eluting stents (DES) in the superficial femoral artery to prevent restenosis have shown conflicting results, with DES showing advantages over BMS in the short term (6 months) [3], but with diminishing benefits over a longer time [6]. Sirolimus-coated stents are more consistently superior for treating focal infrapopliteal lesions when compared with BMS [7]. In the Zilver PTX randomized study of patients with peripheral artery disease, implantation of polymer-free DES led to improved 12-month results compared to balloon dilation, with similar superiority results when balloon dilation was followed by provisional DES stenting [8]. DCB employment in peripheral endovascular procedures has been successfully demonstrated in pre-clinical [14,15,16,17] and clinical [18,19,20,21,22,23,24] studies
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