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  • Review Article
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Drug-coated balloon angioplasty for coronary and peripheral artery disease: latest evidence and clinical indications

Nature Reviews Cardiology (2026)Cite this article

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Abstract

Drug-coated balloons (DCBs) are devices used for the treatment of both coronary artery disease (CAD) and peripheral artery disease (PAD). One of the hypothesized advantages of DCB angioplasty over stent implantation is that DCB angioplasty does not result in the presence of a permanent metallic scaffold in the vessel wall. However, DCB angioplasty also has some important limitations, such as a potentially lower efficacy compared with other modalities; therefore, the role of DCBs in the treatment of CAD and PAD is not fully defined. Over the past 20 years, many clinical trials have been performed to investigate the use of these devices for a variety of indications. In this Review, we describe the device design and mechanism of action of DCBs and discuss important procedural considerations for successful DCB use. We summarize the scientific and clinical evidence for DCB angioplasty in CAD and PAD. In addition, we highlight the recommendations for DCB use in clinical practice guidelines and provide perspectives on the potential future role that DCB angioplasty might have in the treatment of CAD and PAD.

Key points

  • Drug-coated balloon (DCB) angioplasty provides an alternative to drug-eluting stents and plain old balloon angioplasty for the treatment of coronary or peripheral artery disease.

  • The absence of a metallic scaffold with DCB angioplasty compared with stenting might confer a biomechanical and physiological benefit and avoids the implantation of additional stent layers in patients with in-stent restenosis.

  • A class effect cannot be assumed for DCBs; device manufacturers are challenged with finding the best combination of antiproliferative agent and excipient to achieve optimal clinical and angiographic outcomes.

  • Several randomized clinical trials have been performed comparing DCB angioplasty with a variety of comparators in both coronary and peripheral artery disease, although more evidence is needed, particularly in de novo coronary artery disease.

  • Positive results from a trial comparing a paclitaxel-coated balloon with an uncoated balloon in patients with coronary in-stent restenosis led to the approval of a DCB for clinical use in the USA in 2024.

  • In long-segment diffuse atherosclerotic disease, DCBs and drug-eluting stents can be considered to be complementary rather than competing strategies, with DCB angioplasty providing an approach to reduce the number of implanted stents.

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Fig. 1: Drug-coated balloon design and mechanisms of action.
Fig. 2: Clinical trials assessing drug-coated balloon angioplasty for CAD.
Fig. 3: Examples of drug-coated balloon angioplasty in CAD.
Fig. 4: Clinical trials assessing drug-coated balloon angioplasty for peripheral artery disease.
Fig. 5: Example of drug-coated balloon angioplasty in PAD.
Fig. 6: Treatment algorithms for drug-coated balloon angioplasty in CAD.

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Authors and Affiliations

  1. Cardiovascular Research Institute Dublin, Mater Private Network, Dublin, Ireland

    Rory Durand, Daniel O’Callaghan, J. J. Coughlan & Robert A. Byrne

  2. Royal College of Surgeons in Ireland University of Medicine and Health Sciences, Dublin, Ireland

    Daniel O’Callaghan, J. J. Coughlan & Robert A. Byrne

  3. Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Munich, Germany

    Salvatore Cassese

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Correspondence to Robert A. Byrne.

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R.A.B. does not accept direct or personal payments from the medical device or pharmaceutical industry and reports research funding to his institution from Abbott Vascular, Biosensors, Boston Scientific and Translumina with no effect on his personal remuneration. The other authors declare no competing interests.

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Nature Reviews Cardiology thanks Fernando Alfonso, Antonio Colombo, Bernardo Cortese and Bruno Scheller for their contribution to the peer review of this work.

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Review criteria

To identify the scientific evidence on the use of DCBs in the setting of CAD and PAD, we performed systematic literature searches. The search strategy is provided in Supplementary Table 6. Literature searches were performed in PubMed (final search on 20 January 2025) to identify clinical trials investigating DCB angioplasty in patients with CAD (Supplementary Table 7) or PAD (Supplementary Table 8). We prioritized evidence from RCTs. The reference lists from the identified papers were also reviewed to identify additional studies.

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Durand, R., O’Callaghan, D., Coughlan, J.J. et al. Drug-coated balloon angioplasty for coronary and peripheral artery disease: latest evidence and clinical indications. Nat Rev Cardiol (2026). https://doi.org/10.1038/s41569-026-01262-2

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