dc.contributor.author
Gemeinhardt, Ole
dc.contributor.author
Haase, Tobias
dc.contributor.author
Schnorr, Beatrix
dc.contributor.author
Xie, Jing
dc.contributor.author
Löchel, Melanie
dc.contributor.author
Schütt, Denise
dc.contributor.author
Mittag, Antje
dc.contributor.author
Haider, Wolfram
dc.contributor.author
Bettink, Stephanie
dc.contributor.author
Speck, Ulrich
dc.contributor.author
Tepe, Gunnar
dc.date.accessioned
2024-08-13T08:49:50Z
dc.date.available
2024-08-13T08:49:50Z
dc.identifier.uri
https://refubium.fu-berlin.de/handle/fub188/44513
dc.identifier.uri
http://dx.doi.org/10.17169/refubium-44225
dc.description.abstract
Purpose: Clinical data indicate that the drug density on drug-coated balloons (DCBs) might have a role on treatment effect and durability. The aim of the current study was to investigate inhibition of neointimal formation and potential adverse effects after treatment with a novel double-dose DCB in swine.
Material and methods: A four-week study was performed in peripheral arteries of 12 domestic pigs after vessel injury and stent implantation. The novel double-dose DCB with 6-mu g paclitaxel (Ptx)/mm(2) balloon surface (1 x 6) was compared to a standard DCB with 3.5 mu g Ptx/mm(2) (3.5) and uncoated balloons (POBA). Potential adverse effects were stimulated by using three fully overlapping DCBs with 6 mu g Ptx/mm(2) each (3 x 6). Quantitative angiography, histomorphometry and histopathological analyses were performed.
Results: Higher paclitaxel doses per square millimeter of treated arteries were associated with reduced late lumen loss (LLL) in quantitative angiography 4 weeks after treatment (POBA: 0.91 +/- 0.75 mm; 3.5: 0.45 +/- 0.53 mm; 1 x 6: 0.21 +/- 0.41 mm; 3 x 6: - 0.38 +/- 0.65 mm). In histomorphometry, maximal neointimal thickness and neointimal area were the lowest for the 1 x 6 group (0.15 +/- 0.06 mm/1.5 +/- 0.4 mm(2)), followed by 3 x 6 (0.20 +/- 0.07 mm/1.8 +/- 0.4 mm(2)), 3.5 (0.22 +/- 0.12 mm/2.2 +/- 1.1 mm(2)) and POBA (0.30 +/- 0.07 mm/3.2 +/- 0.7 mm(2)). Downstream tissue showed histopathological changes in all groups including POBA, in larger number and different quality (e.g., edema, inflammation, vessel wall necrosis, vasculitis and perivasculitis) in the 3 x 6 group, which did not cause clinical or functional abnormalities throughout the study.
Conclusion: Treatment with the double-dose DCB (6 mu g Ptx/mm(2)) tended to increase inhibition of in-stent neointimal formation and to diminish LLL after peripheral intervention in the porcine model compared to a market-approved DCB with 3.5 mu g Ptx/mm(2).
en
dc.rights.uri
https://creativecommons.org/licenses/by/4.0/
dc.subject
Balloon angioplasty
en
dc.subject
Drug-coated balloon
en
dc.subject
Peripheral artery disease
en
dc.subject
Revascularization
en
dc.subject
Porcine in-stent stenosis model
en
dc.subject.ddc
600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit
dc.title
Improvement of Outcome for Treatment of ‘Restenosis-prone’ Vascular Lesions? Potential Impact of the Paclitaxel dose on Late Lumen Loss in Porcine Peripheral Arteries
dc.type
Wissenschaftlicher Artikel
dcterms.bibliographicCitation.doi
10.1007/s00270-022-03277-x
dcterms.bibliographicCitation.journaltitle
CardioVascular and Interventional Radiology
dcterms.bibliographicCitation.number
12
dcterms.bibliographicCitation.originalpublishername
Springer Nature
dcterms.bibliographicCitation.pagestart
1822
dcterms.bibliographicCitation.pageend
1831
dcterms.bibliographicCitation.volume
45
refubium.affiliation
Charité - Universitätsmedizin Berlin
refubium.funding
Springer Nature DEAL
refubium.resourceType.isindependentpub
no
dcterms.accessRights.openaire
open access
dcterms.bibliographicCitation.pmid
36109387
dcterms.isPartOf.issn
0174-1551
dcterms.isPartOf.eissn
1432-086X