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Background <p>Current guideline recommendations for the treatment of coronary in-stent restenosis (ISR) are primarily based on evidence from smaller, randomized trials comparing drug-coated balloons (DCBs) and second-generation drug-eluting stents (DES).</p> Purpose <p>The purpose was to compare clinical outcomes between DCB and DES in routine clinical practice.</p> Methods <p>In this population-based cohort study, we identified 10,292 patients with ISR who underwent either DCB or DES intervention. After 1:1 propensity score matching, 3942 patients treated with either DCB or second-generation DES were included in the analysis. The composite primary end point was all-cause mortality or myocardial infarction (MI) at 1 year. Secondary end points included each component of the primary end point. The safety end point was defined by hospitalization due to bleeding events.</p> Results <p>At 1-year follow-up, the primary outcome occurred in 10.4% (<i>n</i> = 206) of the DCB group versus 12.9% (<i>n</i> = 254) of the DES group (HR, 0.77; 95% CI, 0.64–0.93). Among secondary outcomes, all-cause mortality was lower in the DCB group (6.3%, <i>n</i> = 125) compared to the DES group (8.1%, <i>n</i> = 160; HR, 0.75; 95% CI, 0.59–0.94), as was hospitalization for bleeding (2.5%, <i>n</i> = 50 vs. 4.2%, <i>n</i> = 82; HR, 0.65; 95% CI, 0.45–0.96). Rates of MI were similar between groups (HR, 0.83; 95% CI, 0.63–1.10).</p> Conclusion <p>DCBs were associated with lower rates of the primary end point all-cause death or myocardial infarction, as well as secondary end points all-cause death and bleeding compared with second-generation DES. These findings suggest that DCBs may represent a safe and effective alternative to DES in selected patient populations.</p> Graphical Abstract <p></p>

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Clinical outcomes of drug-coated balloon vs. second-generation drug-eluting stent for coronary in-stent restenosis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月25日

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  • J. Krefting,
  • N. Krüger,
  • C. Friess,
  • C. Gräßer,
  • R. Schmieder,
  • F. Starnecker,
  • M. Schwab,
  • S. Kufner,
  • T. Trenkwalder,
  • F. Voll,
  • H. B. Sager,
  • T. Kessler,
  • E. Xhepa,
  • F. Offenborn,
  • T. Dreischulte,
  • D. Giacoppo,
  • S. Cassese,
  • A. Kastrati,
  • H. Schunkert,
  • M. von Scheidt,
  • J. Wiebe

摘要

Background

Current guideline recommendations for the treatment of coronary in-stent restenosis (ISR) are primarily based on evidence from smaller, randomized trials comparing drug-coated balloons (DCBs) and second-generation drug-eluting stents (DES).

Purpose

The purpose was to compare clinical outcomes between DCB and DES in routine clinical practice.

Methods

In this population-based cohort study, we identified 10,292 patients with ISR who underwent either DCB or DES intervention. After 1:1 propensity score matching, 3942 patients treated with either DCB or second-generation DES were included in the analysis. The composite primary end point was all-cause mortality or myocardial infarction (MI) at 1 year. Secondary end points included each component of the primary end point. The safety end point was defined by hospitalization due to bleeding events.

Results

At 1-year follow-up, the primary outcome occurred in 10.4% (n = 206) of the DCB group versus 12.9% (n = 254) of the DES group (HR, 0.77; 95% CI, 0.64–0.93). Among secondary outcomes, all-cause mortality was lower in the DCB group (6.3%, n = 125) compared to the DES group (8.1%, n = 160; HR, 0.75; 95% CI, 0.59–0.94), as was hospitalization for bleeding (2.5%, n = 50 vs. 4.2%, n = 82; HR, 0.65; 95% CI, 0.45–0.96). Rates of MI were similar between groups (HR, 0.83; 95% CI, 0.63–1.10).

Conclusion

DCBs were associated with lower rates of the primary end point all-cause death or myocardial infarction, as well as secondary end points all-cause death and bleeding compared with second-generation DES. These findings suggest that DCBs may represent a safe and effective alternative to DES in selected patient populations.

Graphical Abstract