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Drug-Coated Balloons versus Second-Generation Drug-Eluting Stents for In-Stent Restenosis: Insights from Real-World Data

https://doi.org/10.1007/s00392-025-02625-4

Johannes Krefting (München)1, N. Krueger (München)1, C. Friess (München)1, C. Gräßer (München)1, R. S. Schmieder (München)1, F. Starnecker (München)1, S. Kufner (München)1, T. Trenkwalder (München)1, H. Sager (München)1, T. Keßler (München)1, E. Xhepa (München)1, D. Giacoppo (München)1, S. Cassese (München)2, A. Kastrati (München)1, H. Schunkert (München)1, M. von Scheidt (München)1, J. Wiebe (München)3

1Deutsches Herzzentrum München Klinik für Herz- und Kreislauferkrankungen München, Deutschland; 2Deutsches Herzzentrum München München, Deutschland; 3Herz-Gefäss-Zentrum Nymphenburg München, Deutschland

 

Background: Coronary in-stent restenosis (ISR) poses significant challenges. The evidence comparing drug-coated balloons (DCBs) and second-generation drug-eluting stents (DES) in patients with coronary in-stent restenosis (ISR) is based on small, randomized trials.
Purpose: This study aims to compare clinical outcomes between both treatments, utilizing real world data from the OBSERVABLE database, comprising German health claims data between 2012 and 2021.
Methods: A total of 10,440 ISR patients who underwent DCB or DES intervention were identified. After excluding treatments with bare metal stents, 1. generation DES and angioplasty with only non-DCBs as well as 2:1 propensity score matching, 4,983 individuals (DCB: n = 1661, DES: n = 3,322) remained. The composite primary outcome, of all-cause death and myocardial infarction (MI), was analyzed at the 1-year follow-up mark. Secondary outcomes included all-cause death, MI, and bleeding events as safety outcome.
Results: At the 1-year follow-up, the primary outcome was observed for 13.5% (n = 450) in the DES group, compared to 10.8% (n=180) in the DCB group (HR, 1.32; 95% CI, 1.12-1.57). Sensitivity analysis using only single-vessel PCI confirmed the robustness of these findings (HR 1.26, 95% CI, 1.05-1.52). Secondary outcomes at 1 year revealed higher all-cause mortality in the DES group (8.7%) compared to the DCB group (6.7%) (HR, 1.37; 95% CI, 1.10-1.70), with MI occurrences as well as bleeding being comparable between groups.
Conclusion: This analysis revealed a higher incidence of the primary endpoint within one year in the DES group compared to the DCB group, which supports DCB as a viable alternative to DES in ISR treatment.
 
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