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  • Review Article
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Drug-coated balloon therapy in coronary and peripheral artery disease

Nature Reviews Cardiology volume 11, pages 13–23 (2014)Cite this article

Subjects

Key Points

  • Nonstent-based local drug delivery with drug-coated balloons (DCBs) can achieve rapid transfer of a drug to surrounding tissue, and durable antirestenotic efficacy

  • Theoretical advantages of DCBs over drug-eluting stents (DESs) include broad surface contact, homogenous drug distribution, absence of stent footprint or polymer residue, and restoration of normal vessel anatomy and function

  • Preclinical studies have shown that DCB delivery of paclitaxel combined with a hydrophilic spacer (excipient) results in clinically effective local tissue drug concentrations and sustained inhibition of neointimal growth

  • Among patients with coronary bare-metal or drug-eluting stent restenosis, DCBs show similar results to standard-of-care treatment (repeat stenting with a DES) and obviate the need for further stent implants

  • Among patients with de novo coronary artery disease, convincing data from randomized trials to support DCB therapy is lacking, and the use of DCBs for this indication requires further investigation

  • In peripheral artery disease, DCB therapy has proven superior to balloon angioplasty for treatment of de novo femoropopliteal and below-the-knee disease

Abstract

Nonstent-based local drug delivery during percutaneous intervention offers potential for sustained antirestenotic efficacy without the limitations of permanent vascular implants. Preclinical studies have shown that effective local tissue concentrations of drugs can be achieved using drug-coated balloon (DCB) catheters. Matrix coatings consisting of a mixture of lipophilic paclitaxel and hydrophilic spacer (excipient) are most effective. Clinical applications most suited to DCB therapy are those for which stent implantation is not desirable or less effective, such as in-stent restenosis, bifurcation lesions, or peripheral artery stenoses. Randomized trials have shown superiority of DCBs over plain-balloon angioplasty for both bare-metal and drug-eluting coronary in-stent restenosis, and similar efficacy as repeat stenting with a drug-eluting stent (DES). Bycontrast, randomized trials of DCBs in de novo coronary stenosis have, to date, not shown similar efficacy to standard-of-care DES therapy. In peripheral artery disease, DCB therapy has proven superior to plain-balloon angioplasty for treatment of de novo femoropoliteal and below-the-knee disease, and shown promising results for in-stent restenosis. Overall, however, despite many years of clinical experience with DCBs, the number of large, high-quality, randomized clinical trials is low, and further data are urgently needed across the spectrum of clinical indications.

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Figure 1: Drug-coated balloon structure and mechanism of action in in-stent restenosis.
Figure 2: Vascular effects of drug-coated balloon versus plain-balloon angioplasty in a rabbit iliac model.
Figure 3: Comparative efficacy of drug-coated balloon, drug-eluting stent, and balloon angioplasty in the treatment of restenosis within drug-eluting stents.
Figure 4: Risk of target-lesion revascularization in trials in which DCBs were compared with BA or DESs, according to indication.

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Authors and Affiliations

  1. Deutsches Herzzentrum, Technische Universität, Lazarettstrasse 36, D-80636, Munich, Germany

    Robert A. Byrne, Michael Joner & Adnan Kastrati

  2. Cardiac Department, Hospital Universitario de La Princesa, IIS-IP, Universidad Autónoma de Madrid, c/ Diego de León 62, 28006, Madrid, Spain

    Fernando Alfonso

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M. Joner declares that he has received research support from Abbott, Biotronik, Cardionovum, Medtronic, and Zorion; and medical and lecture fees from Abbott, Biotronik, Medtronic, and St. Jude Medical. A. Kastrati declares that he has received lecture fees from Biosensors, Biotronik, and St. Jude Medical. R. A. Byrne and F. Alfonso declare no competing interests.

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Byrne, R., Joner, M., Alfonso, F. et al. Drug-coated balloon therapy in coronary and peripheral artery disease. Nat Rev Cardiol 11, 13–23 (2014). https://doi.org/10.1038/nrcardio.2013.165

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