Postępy w Kardiologii Interwencyjnej

Sex-related differences in long-term outcomes of drug-coated balloons versus thin-strut drug-eluting stents in the treatment of in-stent restenosis (DCB-DRAGON Registry)

Rafał Januszek 1, 2, 3, 4
,
Michał Tarnowski 5
,
Paweł Pawlus 6
,
Sylwia Iwańczyk 7, 8
,
Łukasz Kuźma 9
,
Brunon Tomasiewicz 10
,
Piotr Kubler 10
,
Maciej Wybraniec 11
,
Krystian Wita 11
,
Sławomir Dobrzycki 9
,
Stanisław Bartuś 12
,
Maciej Lesiak 8
,
Robert J. Gil 13
,
Marta Chamera 6
,
Tomasz Pawłowski 13
,
Mariusz Kowalewski 14
,
Damian Grzegorek 2
,
Fecehauwe Mezque 10
,
Agata Stanek 15
,
Filippo Luca Gurgoglione 7, 16, 17
,
Bernardo Cortese 7, 17, 18
,
Fabrizio D’Ascenzo 19
,
Damian Hudziak 20
,
Rafał Wolny 21
,
Adam Kowalówka 20
,
Grzegorz Smolka 22
,
Grzegorz Sobieszek 23
,
Wojciech Wojakowski 6
,
Wojciech Wańha 6, 7, 14

  1. Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Cracow University, Krakow, Poland

  2. Cardiac Catheterization Laboratory, Voivode Hospital in Bełchatow, Poland

  3. Cardiac Catheterization Laboratory, University Hospital in Radomsko, Poland

  4. Cardiac Catheterization Laboratory, American Heart of Poland, Chrzanow, Poland

  5. Department of Cardiology, Holy Spirit Specialist Hospital, Sandomierz, Poland

  6. Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland

  7. DCB Academy, Cleveland, USA

  8. Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland

  9. Department of Invasive Cardiology, Medical University of Bialystok, Poland

  10. Institute of Heart Diseases, University Hospital, Wroclaw Medical University, Wroclaw, Poland

  11. 1st Department of Cardiology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland

  12. 2nd Department of Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland

  13. Department of Cardiology, National Medical Institute of the Ministry of the Interior and Administration, Warsaw, Poland

  14. Department of Cardiac Surgery and Transplantology, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Poland

  15. Department of Internal Medicine, Metabolic Diseases and Angiology, Faculty of Health Sciences, Medical University of Silesia, Upper Silesian Medical Center of the Medical University of Silesia in Katowice, Poland

  16. Division of Cardiology, Parma University Hospital, Parma, Italy

  17. Fondazione Ricerca e Innovazione Cardiovascolare, Milano, Italy

  18. University Hospitals Harrington Heart and Vascular Institute, Cleveland, OH, USA

  19. Division of Cardiology, Department of Internal Medicine, Città della Salute e della Scienza, University of Turin, Italy

  20. Department of Cardiac Surgery, Medical University of Silesia, Katowice, Poland

  21. Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland

  22. Department of Cardiology, School of Health Sciences, Medical University of Silesia, Katowice, Poland

  23. Department of Cardiology, 1st Military Clinical Hospital, John Paul II Catholic University of Lublin, Poland

Adv Interv Cardiol

DOI: https://doi.org/10.5114/aic.2026.164719
Data publikacji online: 2026/09/13
Article file
Sex-related differences.pdf
  1. Alfonso F, Coughlan JJ, Giacoppo D, et al. Management of in-stent restenosis. EuroIntervention 2022; 18: e103-23.
  2. Lawton JS, Tamis-Holland JE, Bangalore S, et al. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 2022; 145: e18-114.
  3. Stefanini GG, Holmes DR Jr. Drug-eluting coronary-artery stents. N Engl J Med 2013; 368: 254-65.
  4. Sharma A, Agrawal S, Garg A, et al. Duration of dual antiplatelet therapy following drug-eluting stent implantation: a systematic review and meta-analysis of randomized controlled trials with longer follow up. Catheter Cardiovasc Interv 2017; 90: 31-7.
  5. Kim C, Kim BK, Lee SY, et al. Incidence, clinical presentation, and predictors of early neoatherosclerosis after drug-eluting stent implantation. Am Heart J 2015; 170: 591-7.
  6. Madhavan MV, Kirtane AJ, Redfors B, et al. Stent-related adverse events >1 year after percutaneous coronary intervention. J Am Coll Cardiol 2020; 75: 590-604.
  7. Elbadawi A, Dang AT, Mahana I, et al. Outcomes of percutaneous coronary intervention for in-stent restenosis versus de novo lesions: a meta-analysis. J Am Heart Assoc 2023; 12: e029300.
  8. Wańha W, Bil J, Januszek R, et al. Long-term outcomes following drug-eluting balloons versus thin-strut drug-eluting stents for treatment of in-stent restenosis (DEB-Dragon-Registry). Circ Cardiovasc Interv 2021; 14: e010868.
  9. Moussa ID, Mohananey D, Saucedo J, et al. Trends and outcomes of restenosis after coronary stent implantation in the United States. J Am Coll Cardiol 2020; 76: 1521-31.
  10. Tamez H, Secemsky EA, Valsdottir LR, et al. Long-term outcomes of percutaneous coronary intervention for in-stent restenosis among Medicare beneficiaries. EuroIntervention 2021; 17: e380-7.
  11. Neumann FJ, Sousa-Uva M, Ahlsson A, et al.; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J 2019; 40: 87-165.
  12. Wolny R, Kowalik I, Januszek R, et al. Long-term outcomes following drug-eluting balloons vs. thin-strut drug-eluting stents for treatment of recurrent restenosis in drug-eluting stents. Kardiol Pol 2022; 80: 765-73.
  13. Cortese B, Kalkat H, Bathia G, et al. The evolution and revolution of drug coated balloons in coronary angioplasty: an up-to-date review of literature data. Catheter Cardiovasc Interv 2023; 102: 1069-77.
  14. Vrints C, Andreotti F, Koskinas KC, et al.; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J 2024; 45: 3415-537.
  15. Mehran R, Chandrasekhar J, Davis S, et al. Impact of race and ethnicity on the clinical and angiographic characteristics, social determinants of health, and 1-year outcomes after everolimus-eluting coronary stent procedures in women. Circ Cardiovasc Interv 2019; 12: e006918.
  16. von Elm E, Altman DG, Egger M, et al.; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet 2007; 370: 1453-7.
  17. Benchimol EI, Smeeth L, Guttmann A, et al.; RECORD Working Committee. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. PLoS Med 2015; 12: e1001885.
  18. Uno H, Claggett B, Tian L, et al. Moving beyond the hazard ratio in quantifying the between-group difference in survival analysis. J Clin Oncol 2014; 32: 2380-5.
  19. Royston P, Parmar MK. Restricted mean survival time: an alternative to the hazard ratio for the design and analysis of randomized trials with a time-to-event outcome. BMC Med Res Methodol 2013; 13: 152.
  20. Hainmueller J. Entropy balancing for causal effects: a multivariate reweighting method to produce balanced samples in observational studies. Polit Anal 2012; 20: 25-46.
  21. Rubin DB. Multiple Imputation for Nonresponse in Surveys. Wiley, New York 1987.
  22. Garcia-Garcia HM, McFadden EP, Farb A, et al.; Academic Research Consortium. Standardized end point definitions for coronary intervention trials: the Academic Research Consortium-2 consensus document. Circulation 2018; 137: 2635-50.
  23. Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. J R Stat Soc Series B Stat Methodol 1995; 57: 289-300.
  24. van Buuren S, Groothuis-Oudshoorn K. mice: multivariate imputation by chained equations in R. J Stat Softw 2011; 45: 1-67.
  25. White IR, Royston P. Imputing missing covariate values for the Cox model. Stat Med 2009; 28: 1982-98.
  26. Fine JP, Gray RJ. A proportional hazards model for the sub-distribution of a competing risk. J Am Stat Assoc 1999; 94: 496-509.
  27. R Core Team. R: a language and environment for statistical computing. Vienna: R Foundation for Statistical Computing; 2026.
  28. Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples. Stat Med 2009; 28: 3083-107.
  29. Schemper M, Smith TL. A note on quantifying follow-up in studies of failure time. Control Clin Trials 1996; 17: 343-6.
  30. Fezzi S, Serruys PW, Cortese B, et al. Indications for use of drug-coated balloons in coronary intervention: Academic Research Consortium position statement. J Am Coll Cardiol 2025; 86: 1170-202.
  31. De Filippo O, Bruno F, Pinxterhuis TH, et al. Treatment of in-stent restenosis with ultrathin-strut versus thin-strut drug-eluting stents or drug-eluting balloons: a multicentre registry. EuroIntervention 2024; 20: e1340-54.
  32. Wańha W, Iwańczyk S, Januszek R, et al. Long-term outcomes following sirolimus-coated balloon or drug-eluting stents for treatment of in-stent restenosis. Circ Cardiovasc Interv 2024; 17: e014064.
  33. Wańha W, D’Ascenzo F, Kuźma Ł, et al. Long-term outcomes following paclitaxel-coated balloons versus thin-strut drug-eluting stents for treatment of in-stent restenosis in chronic coronary syndrome (CCS Dragon-Registry). Kardiol Pol 2024; 82: 749-59.
  34. Verheye S, Vrolix M, Montorfano M, et al. Twelve-month clinical and imaging outcomes of the uncaging coronary DynamX bioadaptor system. EuroIntervention 2020; 16: e974-81.
  35. Leone PP, Testa L, Greco A, et al.; EASTBOURNE Investigators. Two-year clinical outcomes in female and male patients after sirolimus-coated balloon angioplasty for coronary artery disease. Circ Cardiovasc Interv 2025; 18: e014814.
Copyright: © 2026 Termedia Sp. z o. o. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) License (http://creativecommons.org/licenses/by-nc-sa/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
SUBMIT YOUR PAPER
Share
without publication fees
Indexed in
pubmed
Integrated with
integrated with publons
Editorial Policies
Sarajevo Declaration on Integrity and Visibility of Scholarly Publications