IMR Press / FBL / Volume 27 / Issue 10 / DOI: 10.31083/j.fbl2710283
Open Access Original Research
Drug-Coated Balloons: Drugs Beyond Paclitaxel?
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1 Experimental Radiology, Charité-Universitätsmedizin Berlin, 10117 Berlin, Germany
2 InnoRa GmbH, 10115 Berlin, Germany
3 Clinical and Experimental Interventional Cardiology, University of Saarland, 66421 Homburg/Saar, Germany
*Correspondence: (Tobias Haase)
Academic Editor: Muntasir Billah
Front. Biosci. (Landmark Ed) 2022, 27(10), 283;
Submitted: 13 June 2022 | Revised: 6 September 2022 | Accepted: 15 September 2022 | Published: 10 October 2022
(This article belongs to the Special Issue Novel therapeutic approaches to cardiovascular diseases)
Copyright: © 2022 The Author(s). Published by IMR Press.
This is an open access article under the CC BY 4.0 license.

Background: Although controversially discussed, paclitaxel is the only clinically proven drug that inhibits restenosis when released from drug-coated balloons (DCBs). Limus drugs are currently being explored as alternatives. The aim of the preclinical studies was to investigate drug candidates beyond paclitaxel considered for balloon coating. Methods: Drugs were tested with respect to dissolution in organic solvents, coating on balloons, and drug transfer to the vessel wall. Inhibition of neointimal proliferation was tested in the porcine model of coronary in-stent stenosis. Intravascular drug treatment was achieved by DCBs at the time of stent implantation. Results: Coating had to be adjusted for each drug. Doses on the balloons ranged from 1.0 to 8.6 μg/mm2 balloon surface. Satisfactory amounts of drug ranging from 5% to 29% of initial doses were transferred into the vessel wall. Angiographic parameters such as late lumen loss (LLL) at 4 weeks did not show reduction of in-stent neointimal proliferation by treatment with arsenic trioxide (0.87 ± 0.44 mm), betamethasone dipropionate (1.00 ± 0.54 mm), bortezomib (1.74 ± 0.46 mm), green tea extract (1.24 ± 0.51 mm), fantolon, an epothilone (0.86 ± 0.61 mm), methotrexate (1.09 ± 0.72 mm), and thalidomide (1.59 ± 0.55 mm) compared to treatment with uncoated balloons (1.07 ± 0.60 mm), while coatings with paclitaxel reliably reduced in-stent stenosis (LLL = 0.36 ± 0.25 mm). Conclusions: Despite the proven antiproliferative and/or anti-inflammatory effect of the drugs, none of the coatings significantly reduced LLL compared to uncoated balloons and thus, based on the results presented here, none of the tested coatings may be considered a substitute for the paclitaxel-based coatings currently in clinical use.

drug coated balloons
in-stent stenosis
neointima formation
coronary heart disease
endovascular therapies
Fig. 1.
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