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Background <p>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.</p> Methods <p>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.</p> Results <p>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&#xa0;years (IQR 2.7–9.3). There were no significant differences in cardiovascular (CV) mortality (HR 1.01 [95% CI 0.87–1.19], <i>p</i> value 0.874), all-cause mortality (HR 1.05 [95% CI 0.91–1.22], <i>p</i> value 0.491), MACE (HR 1.10 [95% CI 0.96–1.26], <i>p</i> value 0.170), acute myocardial infarction (HR 1.08 [95% CI 0.90–1.19], <i>p</i> value 0.308), or any revascularization (HR 1.03 [95% CI 0.90–1.19], <i>p</i> 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], <i>p</i> value 0.072), and in side branch lesions (HR 0.79 [95% CI 0.58–1.04], <i>p</i> value 0.096).</p> Conclusion <p>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.</p> Graphical abstract <p></p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月23日

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  • Ulrike Baumer,
  • Eva Steinacher,
  • Andreas Hammer,
  • Niema Kazem,
  • Felix Hofer,
  • Bernhard Frey,
  • Irene Lang,
  • Christian Hengstenberg,
  • Rayyan Hemetsberger,
  • Patrick Sulzgruber,
  • Alexander Niessner,
  • Lorenz Koller

摘要

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