Drug-coated balloon vs drug-eluting stent in de novo coronary lesions - a propensity score matched cohort study

Sep 30, 2026

Uploaded by Eliana

Propensity score matched clinical research evaluates drug-coated balloons (DCB) versus drug-eluting stents (DES) for treating de novo coronary lesions, reflecting growing DCB use in percutaneous coronary interventions (PCI) but limited robust data beyond in-stent restenosis. All DCB-treated de novo lesion patients from 2010 to 2019 at a single institution were matched 1:1 to comparable DES-treated patients, with follow-up through 09/2022 to measure safety and efficacy endpoints. Results show no significant between-group differences in mortality, MACE, myocardial infarction, or any revascularization. A trend suggests lower target lesion revascularization in small vessel disease and side branch lesions, supporting long-term safety and efficacy signals.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages9

Reading Time23 min

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Abstract

Background

Methods

Results

Conclusion

Introduction

Methods

Study population

Propensity score matching

Clinical Research in Cardiology (2025) 115:60–68 [https://doi.org/10.1007/s00392-025-02700-w](https://doi.org/10.1007/s00392-025-02700-w) Drug‑coated balloon vs drug‑eluting stent in de novo coronary lesions: a propensity score matched cohort study Ulrike Baumer1 · Eva Steinacher1 · Andreas Hammer1 · Niema Kazem1 · Felix Hofer1 · Bernhard Frey1 · Irene Lang1 · Christian Hengstenberg1 · Rayyan Hemetsberger1 · Patrick Sulzgruber1 · Alexander Niessner1,2 · Lorenz Koller1 Received: 17 March 2025 / Accepted: 8 June 2025 / Published online: 23 June 2025 © The Author(s) 2025 Abstract Background The use of drug-coated balloons (DCB) in percutaneous coronary interventions (PCI) is increasing due to potential benefits mainly by avoiding foreign material although a widespread application area beyond in-stent restenosis lacks robust clinical data to date. As such, we aimed to assess the safety and efficacy of DCBs in treating de novo lesions. Methods For this analysis, we included all patients treated with DCB in a de novo lesions from 2010 to 2019 at our institution. We performed a 1:1 propensity score matching to pair each DCB intervention with a comparable DES intervention. Follow-up continued until 09/2022 to assess clinical outcomes. Results A total of 303 patients with de novo lesion were matched to 303 patients with comparable baseline characteristics. The median follow-up time was 5.7 years (IQR 2.7–9.3). There were no significant differences in cardiovascular (CV) mortality (HR 1.01 [95% CI 0.87–1.19], p value 0.874), all-cause mortality (HR 1.05 [95% CI 0.91–1.22], p value 0.491), MACE (HR 1.10 [95% CI 0.96–1.26], p value 0.170), acute myocardial infarction (HR 1.08 [95% CI 0.90–1.19], p value 0.308), or any revascularization (HR 1.03 [95% CI 0.90–1.19], p value 0.671) between both groups. However, we observed a trend toward lower rates of target lesion revascularization in patients with small vessel disease (HR 0.84 [95% CI 0.68–1.02], p value 0.072), and in side branch lesions (HR 0.79 [95% CI 0.58–1.04], p value 0.096) . Conclusion DCBs demonstrated long-term safety and efficacy in de novo lesions, with promising trends in reducing target lesion revascularization in small vessel disease and side branches. Graphical abstract Ulrike Baumer, Eva Steinacher have equal contribution. Extended author information available on the last page of the article Keywords Percutaneous coronary intervention · Drug-coated balloons · Propensity score matching · Drug-eluting stent Abbreviations CI Confidence interval DCB Drug-coated balloon DES Drug-eluting stent HR Hazard ratio IQR Inter-quartile range MACE Major adverse cardiac event PCI Percutaneous coronary intervention SD Standard deviation Introduction Drug eluting stents (DES) revolutionized the treatment of patients with acute and chronic coronary syndromes and substantially contributed to the success of percutaneous coronary interventions (PCI) . Despite well-investigated advantages, their use is also associated with several adverse events, including stent thrombosis and in-stent restenosis caused by impaired re-endothelialization, stent malapposition, hypersensitivity reactions and neoatherosclerosis [1] . The incidence of stent thrombosis ranges from 1 to 2%, remaining a serious and potentially fatal complication in PCI [2] . In-stent restenosis leading to re-intervention still occurs in up to 2% of patients per year [3]. In this respect, drug-coated balloons (DCB) are hypothesized to offer various advantages. No foreign material is left within the vessel, DCBs provide a homogenous drug delivery to the vessel wall and eliminate the need for polymer use. Additionally, they may allow for reduced intensity and duration of antiplatelet therapy with an according decrease in bleeding risk [4] . Primarily used in in-stent restenosis or smaller vessels, we now see a broader clinical application including larger vessels, multivessel disease and even PCIso

FAQs

What was the study designed to evaluate in de novo coronary lesions?

The study assessed the safety and efficacy of drug-coated balloons compared with drug-eluting stents for treating de novo lesions.

How were patients compared between DCB and DES groups?

A 1:1 propensity score matching was used to pair each DCB intervention with a comparable DES intervention.

What were the main clinical outcome findings?

There were no significant differences between groups in cardiovascular and all-cause mortality, MACE, acute myocardial infarction, or any revascularization.

Did the study observe any subgroup signals?

Yes, trends toward lower target lesion revascularization were observed in patients with small vessel disease and in side branch lesions.

Sep 30, 2026

Uploaded by Eliana