DCB therapy: quo vadis - Coronary artery disease evidence discussion

Sep 30, 2026

DCB therapy: quo vadis? examines the current clinical and guideline-based standing of drug-coated balloons for coronary artery disease. It contrasts a critical view reflected in recent European Society of Cardiology guidance for chronic coronary syndromes with accumulating research on DCB versus drug-eluting stents, including registry and propensity score matched data and evidence from randomized trials and patient-level meta-analysis. The discussion highlights potential advantages in de novo small-vessel and bifurcation subgroups, while addressing unresolved limitations in lesion preparation and event endpoints.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages5

Reading Time13 min

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DCB therapy: quo vadis?

Background and guideline position

Emerging evidence vs prior skepticism

Comparative findings: DCB versus DES

Evidence strengths, limitations, and practical implications

Clinical Research in Cardiology (2025) 115:164–168 [https://doi.org/10.1007/s00392-025-02733-1](https://doi.org/10.1007/s00392-025-02733-1) DCB therapy: quo vadis? Bruno Scheller1,2 · Bernhard Haring2,3 Received: 9 July 2025 / Accepted: 23 July 2025 / Published online: 6 August 2025 © The Author(s) 2025 Sirs, At the 2024 Heart Days meeting of the German Cardiac Society (DGK) in Hamburg, a session of the Interventional Cardiology Working Group (AGIK) entitled ‘DCB—Hereto stay?’ was focused on the role of drug coated balloons (DCB) in the treatment of coronary artery disease. It was common sense, that DCB therapy is currently not a valid option given the lack of evidence and actual guidelines. In fact, this critical view on DCB therapy is supported by recent European Society of Cardiology (ESC) guidelines on the management of chronic coronary syndromes (CCS) [1] . A few years ago, DCB therapy had been considered a recommended procedure for the treatment of in-stent restenosis [2], but this has been retracted in the latest CCS guidelines [1] . The reasons for this downgrade have been discussed controversially, especially the focus on efficiency (target lesion revascularization) while not observing hard clinical endpoints such as myocardial infarction and death being in favor of DCB treatment by avoiding additional stent layers [3] . There was also consensus in the ESC guidelines that DCB have no role in the treatment of de novo lesions [2] . But do these views on DCB therapy actually reflect the available clinical evidence [4–8]? DCB therapy is one of the hot topics at international scientific meetings. The number of scientific publications on DCB therapy is increasing exponentially and so is the evidence for DCB therapy [7, 9] . One may therefore ask: Is the criticism and neglect of DCB therapy still justified? Importantly, this treatment method is not new. The first experimental description of the procedure was published * Bruno Scheller [bruno.scheller@uks.eu](bruno.scheller@uks.eu) 1 Clinical and Experimental Interventional Cardiology, University of Saarland, Homburg/Saar, Germany 2 Department of Internal Medicine III, Saarland University Hospital, Homburg/Saar, Germany 3 Department of Medicine IV, Clinic Hietzing, Vienna, Austria more than 20 years ago [10], followed by the first-in-man study in the New England Journal of Medicine [11] . The justification for DCB are the limitations of drug elutingstents (DES) . The rate of percutaneous coronary interventions (PCI) for in-stent restenosis is still up to 10% of all PCI [12] . Beyond the first year after DES implantation, a device-associated event rate of 2 to 3% can be expected without flattening of the curve over time [13, 14] . The risk increases with the number and length of the implanted DESand increases further as the vessel diameter decreases [14] . Patients with risk factors such as diabetes mellitus are particularly affected [14] . It therefore makes sense to consider alternatives to permanent implants, at least to reduce their total number and length [9] . Baumer and colleagues deserve recognition and congratulations for their contribution to the growing clinical evidence of DCB therapy [15] . In the current issue of Clinical Research in Cardiology, they present a propensity score matched analysis of 606 patients with treatment of de novo lesions with either DES or DCB. The median follow-up time was 5.7 years without significant differences in cardiovascular or all-cause mortality, major adverse cardiovascular events (MACE), acute myocardial infarction, or any revascularization between DES and DCB. Importantly, the authors observed a trend toward lower rates of target lesion revascularization in patients with small vessel disease (SVD), and in bifurcation side branch lesions in favor of DCB treatment [15] . Their findings compare well to randomized clinical trials (RCT) in SVD. The largest RCT to date, the Basket Small 2 study showed non-i

FAQs

Why is DCB therapy viewed skeptically in current guideline discussions?

The text states that DCB therapy is considered not a valid option due to lack of evidence and actual guideline support, including downgrading from earlier recommendations for in-stent restenosis. It also notes controversy around focusing on efficiency endpoints rather than hard clinical endpoints like myocardial infarction and death.

What evidence is presented to challenge the neglect of DCB therapy?

The article argues that the number of publications on DCB therapy is rising rapidly, and it cites analyses and trials comparing DCB with DES. It specifically mentions propensity score matched data in de novo lesions and comparisons with randomized clinical trials in small vessel disease.

In which lesion subsets does DCB show trends that may favor its use?

The text reports a trend toward lower target lesion revascularization for DCB in patients with small vessel disease and in bifurcation side branch lesions. It also describes lower risk signals for MACE at three years in the patient-level meta-analysis within small vessel disease.

Sep 30, 2026

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