A novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions.

<h4>Background</h4>Drug coated balloons (DCB) with paclitaxel (Ptx) dose of 2-3.5 μg/mm2 balloon surface inhibit restenosis with different effectiveness and duration of success. A clinical dose finding study is not known for any of the currently marketed products. The aim of the present...

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Autores principales:	Ole Gemeinhardt, Beatrix Schnorr, Ulrich Speck, Bruno Scheller
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/75e61c76906c4cc6b18d6202167a6932
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spelling	oai:doaj.org-article:75e61c76906c4cc6b18d6202167a69322021-12-02T20:13:21ZA novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions.1932-620310.1371/journal.pone.0259106https://doaj.org/article/75e61c76906c4cc6b18d6202167a69322021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0259106https://doaj.org/toc/1932-6203<h4>Background</h4>Drug coated balloons (DCB) with paclitaxel (Ptx) dose of 2-3.5 μg/mm2 balloon surface inhibit restenosis with different effectiveness and duration of success. A clinical dose finding study is not known for any of the currently marketed products. The aim of the present preclinical trial was to investigate a novel DCB coated with 6 μg Ptx/mm2 in a porcine model.<h4>Methods and results</h4>The current study investigated a DCB with a novel, modified iopromide based matrix with 6 μg Ptx/mm2. Drug transfer to the vessel wall of peripheral arteries was compared with a dose of 3 μg Ptx/mm2 and two fully overlapping DCB with 3 μg Ptx/mm2, each. Ptx concentration in the vessel wall after drug transfer was about twice as high for balloons with 6 μg/mm2 (1957±1472 μg/g) and two overlapping DCB with 3 μg Ptx/mm2, each (1287±619 μg/g) compared to a single balloon with 3 μg Ptx/mm2, (787±738 μg/g), with statistical significant differences for 1x6 μg/mm2 vs. 1x3 μg/mm2 (p = 0.017) but not for 2x3 μg/mm2 vs. 1x3 μg/mm2 (p = 0.184) and 1x6 μg/mm2 vs. 2x3 μg/mm2 (p = 0.178). The proportion of residual Ptx on balloon after treatment was similar for all groups between 6±1% and 10±3% of dose on balloon.<h4>Conclusion</h4>The dose of 6 μg Ptx/mm2 was successfully as well as reproducibly coated on conventional balloon catheters. Increased Ptx on balloons resulted in increased drug concentration in the vessel wall. A single balloon with 6 μg Ptx/mm2 seems to provide double dose compared to 3 μg Ptx/mm2, facilitates the procedure, and may reduce medico-economic cost compared to the use of two standard DCB.Ole GemeinhardtBeatrix SchnorrUlrich SpeckBruno SchellerPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 10, p e0259106 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Ole Gemeinhardt Beatrix Schnorr Ulrich Speck Bruno Scheller A novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions.
description	<h4>Background</h4>Drug coated balloons (DCB) with paclitaxel (Ptx) dose of 2-3.5 μg/mm2 balloon surface inhibit restenosis with different effectiveness and duration of success. A clinical dose finding study is not known for any of the currently marketed products. The aim of the present preclinical trial was to investigate a novel DCB coated with 6 μg Ptx/mm2 in a porcine model.<h4>Methods and results</h4>The current study investigated a DCB with a novel, modified iopromide based matrix with 6 μg Ptx/mm2. Drug transfer to the vessel wall of peripheral arteries was compared with a dose of 3 μg Ptx/mm2 and two fully overlapping DCB with 3 μg Ptx/mm2, each. Ptx concentration in the vessel wall after drug transfer was about twice as high for balloons with 6 μg/mm2 (1957±1472 μg/g) and two overlapping DCB with 3 μg Ptx/mm2, each (1287±619 μg/g) compared to a single balloon with 3 μg Ptx/mm2, (787±738 μg/g), with statistical significant differences for 1x6 μg/mm2 vs. 1x3 μg/mm2 (p = 0.017) but not for 2x3 μg/mm2 vs. 1x3 μg/mm2 (p = 0.184) and 1x6 μg/mm2 vs. 2x3 μg/mm2 (p = 0.178). The proportion of residual Ptx on balloon after treatment was similar for all groups between 6±1% and 10±3% of dose on balloon.<h4>Conclusion</h4>The dose of 6 μg Ptx/mm2 was successfully as well as reproducibly coated on conventional balloon catheters. Increased Ptx on balloons resulted in increased drug concentration in the vessel wall. A single balloon with 6 μg Ptx/mm2 seems to provide double dose compared to 3 μg Ptx/mm2, facilitates the procedure, and may reduce medico-economic cost compared to the use of two standard DCB.
format	article
author	Ole Gemeinhardt Beatrix Schnorr Ulrich Speck Bruno Scheller
author_facet	Ole Gemeinhardt Beatrix Schnorr Ulrich Speck Bruno Scheller
author_sort	Ole Gemeinhardt
title	A novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions.
title_short	A novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions.
title_full	A novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions.
title_fullStr	A novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions.
title_full_unstemmed	A novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions.
title_sort	novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/75e61c76906c4cc6b18d6202167a6932
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A novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions.

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