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. 2025 Nov 25.
doi: 10.1007/s00392-025-02781-7. Online ahead of print.

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

J Krefting #  1   2 , N Krüger #  3   4 , C Friess  3 , C Gräßer  3   4 , R Schmieder  3   4 , F Starnecker  3   4 , M Schwab  3   4 , S Kufner  3   4 , T Trenkwalder  3   4 , F Voll  3   4 , H B Sager  3   4 , T Kessler  3   4 , E Xhepa  3   4 , F Offenborn  5 , T Dreischulte  6 , D Giacoppo  3   4 , S Cassese  3   4 , A Kastrati  3   4 , H Schunkert  3   4 , M von Scheidt #  3   4 , J Wiebe #  7   8
Affiliations

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

J Krefting et al. Clin Res Cardiol. .

Abstract

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.

Keywords: Coated balloon, Second; Eluting stent, Real; Generation drug; In-; Stent restenosis, Drug; World evidence.

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Conflict of interest statement

Declarations. Conflict of interest: J.K., C.F., R.S., F.S., M.S., T.T., F.V., E.X., F.O., T.D., D.G., S.C., and J.W. report no disclosures N.K. reported receiving grants from the German Heart Foundation and the Deutsches Zentrum für Herz-Kreislauf-Forschung outside the submitted work. M.v.S. has been supported by an excellence grant of the German Center for Cardiovascular Research (DZHK-81X3600506) and is also funded by the Corona Foundation as part of the Junior Research Group Somatic Mutations (S199/10085/2021). M.v.S. and H.S. have received funding from the European Union (HORIZON) for the Multiomics based Risk stratification of Atherosclerotic CardiovascuLar disEase project (MIRACLE: 101115381). H.B.S. has received funding from the European Research Council under the European Union’s Horizon 2020 Research and Innovation Programme (STRATO, grant agreement No. 759272), the “Else-Kröner-Fresenius-Stiftung” (2020_EKSE.07), and the “Deutsche Forschungsgemeinschaft (DFG)” (515567441, 470462396, and CRC 1123 (B11)). T.K.’s work is funded by the European Union (ERC, MATRICARD, 101077205; to T.K.). Views and opinions expressed are, however, those of the authors only and do not necessarily reflect those of the European Union or the European Research Council. Neither the European Union nor the granting authority can be held responsible for them. T.K.’s work is also funded by the Corona Foundation as part of the Junior Research Group Translational Cardiovascular Genomics (S199/10070/2017) and the German Research Foundation (DFG) as part of the collaborative research center SFB 1123 (B2, to T.K. and H.S.), the research project KE 2116/4–1), and the Heisenberg Program (KE 2116/5–1). C.G. has been supported by an excellence grant of the German Center for Cardiovascular Research (FKZ-81X3600511). H.B.S. received lecture fees and travel support from Novo Nordisk Pharma GmbH, AstraZeneca GmbH, Translumina, and Abbott Medical GmbH. H.S., A.K., and T.K. are named inventors on a patent application for prevention of restenosis after angioplasty and stent implantation outside the submitted work. T.K. received lecture fees from Translumina, Bristol-Myers Squibb, Abbott, and Astra-Zeneca, which are unrelated to this work. S.K. reports speaker and consulting fees from AstraZeneca, Bristol Myers Squibb, and Bentley, speaker fees from Abbott, Boehringer-Ingelheim, and Translumina, and a research grant from Bentley, not related to the current work

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