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/4d8ee17b77ac461ca4a5163a6fc3ea4c
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spelling	oai:doaj.org-article:4d8ee17b77ac461ca4a5163a6fc3ea4c2021-11-04T06:49:31ZA novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions1932-6203https://doaj.org/article/4d8ee17b77ac461ca4a5163a6fc3ea4c2021-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8555778/?tool=EBIhttps://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 (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/4d8ee17b77ac461ca4a5163a6fc3ea4c
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A novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions

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