What question did this study set out to answer?

This analysis aims to evaluate the safety and efficacy of drug-coated balloons in treating de novo coronary lesions compared to drug-eluting stents.

February 6, 2026

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

Key Points

This analysis aims to evaluate the safety and efficacy of drug-coated balloons in treating de novo coronary lesions compared to drug-eluting stents.
Included patients treated with DCBs in de novo lesions from 2010 to 2019.
Performed 1:1 propensity score matching to compare DCB interventions with drug-eluting stents.
Primary endpoint was target lesion revascularization, with follow-up until 09/2022 for clinical outcomes.
303 patients were matched between DCB and DES groups based on baseline characteristics.
No significant differences in cardiovascular mortality, all-cause mortality, MACE, or myocardial infarction between DCB and DES groups.
Trends suggest lower rates of target lesion revascularization in DCB patients with small vessel disease compared to DES.

Abstract

Abstract Background The usage of drug-coated balloons (DCB) in percutaneous coronary interventions (PCI) is increasing due to potential benefits, mainly by avoiding foreign material. However, a widespread application area beyond in-stent restenosis lacks robust clinical data. Purpose Here our aim was 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 de novo lesions from 2010 to 2019 at a tertiary care center. We performed a 1:1 propensity score matching to pair each DCB intervention with a comparable DES intervention. The primary study endpoint was target lesion revascularization. Follow-up continued until 09/2022 to assess clinical outcomes. Results A total of 303 patients with de novo lesions were matched to 303 patients with comparable baseline characteristics. The median follow-up time was 5.7 years (IQR 2.7-9.3). Age, sex, comorbidities, and laboratory values were evenly distributed in both matching groups. Differences were found for the variable multivessel disease prior to index PCI, which was slightly higher in the DCB group. In patients with a DCB intervention, the vessel diameter of the matched lesion was somewhat smaller (2.5mm IQR 2.0-2.5mm vs 2.5mm 2.25-2.75mm, p-value 0.001) compared to patients with DES intervention. Meanwhile, the total device length used in DCB interventions (41mm IQR 20-66mm vs 26mm IQR [18-48mm) as well as the proportion of side branch interventions (150 49.5% vs 93 30.7%) were significantly higher in the DCB group (respectively p-values 0.001). 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, with 2.6% (n=6) in the DCB group vs. 5.5% (n=12) in the DES group (HR 0.84 95% CI 0.68-1.02, p-value 0.072). Meanwhile, interventions with a diameter 2.5 mm showed no significant difference (DCB 8.5% n=6 vs. DES 9.5% n=8, HR 0.95 95% CI 0.69-1.30, p-value 0.745, Figure 1). There was a similar trend for target lesion revascularization in side branch interventions, with 1.3% (n=2) in DCB interventions vs 5.4% (n=5, HR 0.79 IQR 0.58-1.04, p-value 0.096) in DES interventions. 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.DCB vs DES in de novo lesions

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