title: Coating of intravascular balloon with paclitaxel prevents constrictive remodeling of the dilated porcine femoral artery due to inhibition of intimal and media fibrosis.
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.
authors.affiliation: Department of Cardiology, Medical University of Vienna, Währinger Gürtel 18-20, Vienna, 1090, Austria.
authors.forename: Noemi
authors.initials: N
authors.lastname: Pavo
authors.affiliation: Department of Pulmonology, Medical University of Vienna, Vienna, Austria.
authors.forename: Eslam
authors.initials: E
authors.lastname: Samaha
authors.affiliation: Department of Cardiology, Medical University of Vienna, Währinger Gürtel 18-20, Vienna, 1090, Austria.
authors.forename: Inna
authors.initials: I
authors.lastname: Sabdyusheva
authors.affiliation: Eurocor GmbH, Bonn, Germany.
authors.forename: Rembert Pogge
authors.initials: RP
authors.lastname: von Strandmann
authors.affiliation: Eurocor GmbH, Bonn, Germany.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Stahnke
authors.affiliation: Department of Cardiology, Medical University of Vienna, Währinger Gürtel 18-20, Vienna, 1090, Austria.
authors.forename: Christian A
authors.initials: CA
authors.lastname: Plass
authors.affiliation: Department of Cardiology, Medical University of Vienna, Währinger Gürtel 18-20, Vienna, 1090, Austria.
authors.forename: Katrin
authors.initials: K
authors.lastname: Zlabinger
authors.affiliation: Department of Cardiology, Medical University of Vienna, Währinger Gürtel 18-20, Vienna, 1090, Austria.
authors.forename: Dominika
authors.initials: D
authors.lastname: Lukovic
authors.affiliation: Heart Center, Semmelweis University, Budapest, Hungary.
authors.forename: Zoltan
authors.initials: Z
authors.lastname: Jambrik
authors.affiliation: Department of Cardiology, Medical University of Vienna, Währinger Gürtel 18-20, Vienna, 1090, Austria.
authors.forename: Imre J
authors.initials: IJ
authors.lastname: Pavo
authors.affiliation: Department of Cardiology, Medical University of Vienna, Währinger Gürtel 18-20, Vienna, 1090, Austria.
authors.forename: Jutta
authors.initials: J
authors.lastname: Bergler-Klein
authors.affiliation: Center for Interventional Vascular Therapy, Columbia-Presbyterian Hospital, New York, NY, USA.
authors.forename: William A
authors.initials: WA
authors.lastname: Gray
authors.affiliation: Department of Cardiology, Medical University of Vienna, Währinger Gürtel 18-20, Vienna, 1090, Austria.
authors.forename: Gerald
authors.initials: G
authors.lastname: Maurer
authors.affiliation: Department of Cardiology, Medical University of Vienna, Währinger Gürtel 18-20, Vienna, 1090, Austria. mariann.gyongyosi@meduniwien.ac.at.
authors.forename: Mariann
authors.initials: M
authors.lastname: Gyöngyösi
mesh_terms: D000792:Angiography / Q000379:methods; D000800:Angioplasty, Balloon / Q000295:instrumentation*; D000818:Animals; D020099:Coated Materials, Biocompatible / Q000737:chemistry; D004867:Equipment Design; D005263:Femoral Artery / Q000473:pathology*; D005355:Fibrosis; D006965:Hyperplasia; D007083:Iliac Artery / Q000473:pathology*; D008422:Materials Testing; D023421:Models, Animal; D058426:Neointima / Q000473:pathology; D017239:Paclitaxel / Q000737:chemistry*; D034421:Sus scrofa; D013552:Swine; D041623:Tomography, Optical Coherence; D017539:Tunica Intima / Q000473:pathology*; D017540:Tunica Media / Q000473:pathology*; D014661:Vasoconstriction; D014664:Vasodilation
chemical_list: D020099:Coated Materials, Biocompatible; D017239:Paclitaxel