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)
18 affiliations
- 1Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Cracow University, Krakow, Poland
- 2Department of Cardiology, Holy Spirit Specialist Hospital, Sandomierz, Poland
- 3Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
- 4DCB Academy, Cleveland, USA
- 5Department of Invasive Cardiology, Medical University of Bialystok, Poland
- 6Institute of Heart Diseases, University Hospital, Wroclaw Medical University, Wroclaw, Poland
- 71 Department of Cardiology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland
- 82 Department of Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland
- 9Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland
- 10Department of Cardiology, National Medical Institute of the Ministry of the Interior and Administration, Warsaw, Poland
- 11Department of Cardiac Surgery and Transplantology, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Poland
- 12Cardiac Catheterization Laboratory, Voivode Hospital in Bełchatow, Poland
- 13Department 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
- 14Division of Cardiology, Department of Internal Medicine, Città della Salute e della Scienza, University of Turin, Italy
- 15Department of Cardiac Surgery, Medical University of Silesia, Katowice, Poland
- 16Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland
- 17Department of Cardiology, School of Health Sciences, Medical University of Silesia, Katowice, Poland
- 18Department of Cardiology, 1 Military Clinical Hospital, John Paul II Catholic University of Lublin, Poland
Abstract
Introduction: Drug-coated balloons (DCB) and drug-eluting stents (DES) are established options for coronary in-stent restenosis (ISR); evidence on sex-specific outcomes remains limited.
Aim: To determine whether sex modifies the comparative effectiveness of DCB versus thin-strut, second-generation DES in ISR.
Material and methods: Retrospective analysis of 1,317 patients undergoing percutaneous coronary intervention for ISR, 2008–2021. Because 57.6% were censored before 3 years, the primary estimand is the difference in restricted mean survival time (RMST) over 0–3 years for the device-oriented composite endpoint (DOCE). Counterfactual survival was estimated by weighted Kaplan–Meier estimation with entropy-balancing weights within each sex stratum; variance was estimated using bootstrap resampling pooled across 20 imputed datasets by Rubin’s rules.
Results: Among 395 (30.0%) women and 922 (70.0%) men, 209 DOCE events accrued. Median observation time differed approximately twofold between arms (20.6 vs. 38.7 months in women; 19.7 vs. 39.4 months in men). The RMST difference was –0.047 years (95% CI: –0.579 to +0.486) in women and +0.036 (–0.186 to +0.259) in men, a sex difference of –0.083 years (–0.661 to +0.495; p = 0.78); weighted HRs were 0.76 (0.43–1.34) and 0.73 (0.50–1.07), respectively. No secondary endpoint showed heterogeneity: every uncorrected p exceeded 0.5 and every false-discovery-rate-adjusted value equalled 0.82. Cardiovascular deaths were similar between arms in women (5 vs. 5) and men (16 vs. 15); weighted HRs for all-cause mortality were 1.03 (0.39–2.72) and 0.78 (0.42–1.46), respectively.
Conclusions: Sex did not modify the comparative effectiveness of DCB versus thin-strut DES for ISR, on the composite endpoint or on any component; these data do not support sex-based device selection. Wide intervals and differential follow-up establish the absence of detectable heterogeneity rather than equivalence.
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BibTeX
@article{januszek2026sexrelated,
title = {{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)}},
author = {Rafał Januszek and Michał Tarnowski and Paweł Pawlus and Sylwia Iwańczyk and Łukasz Kuźma and Brunon Tomasiewicz and Piotr Kubler and Maciej Wybraniec and Krystian Wita and Sławomir Dobrzycki and Stanisław Bartuś and Maciej Lesiak and Robert J. Gil and Marta Chamera and Tomasz Pawłowski and Mariusz Kowalewski and Damian Grzegorek and Fecehauwe Mezque and Agata Stanek and Filippo Luca Gurgoglione and Bernardo Cortese and Fabrizio D’Ascenzo and Damian Hudziak and Rafał Wolny and Adam Kowalówka and Grzegorz Smolka and Grzegorz Sobieszek and Wojciech Wojakowski and Wojciech Wańha},
journal = {Postepy w kardiologii interwencyjnej = Advances in interventional cardiology},
year = {2026},
month = sep,
doi = {10.5114/aic.2026.164719},
url = {https://europepmc.org/article/PMC/PMC13721073},
note = {CC BY-NC-SA},
}
RIS
TY - JOUR
TI - 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)
AU - Rafał Januszek
AU - Michał Tarnowski
AU - Paweł Pawlus
AU - Sylwia Iwańczyk
AU - Łukasz Kuźma
AU - Brunon Tomasiewicz
AU - Piotr Kubler
AU - Maciej Wybraniec
AU - Krystian Wita
AU - Sławomir Dobrzycki
AU - Stanisław Bartuś
AU - Maciej Lesiak
AU - Robert J. Gil
AU - Marta Chamera
AU - Tomasz Pawłowski
AU - Mariusz Kowalewski
AU - Damian Grzegorek
AU - Fecehauwe Mezque
AU - Agata Stanek
AU - Filippo Luca Gurgoglione
AU - Bernardo Cortese
AU - Fabrizio D’Ascenzo
AU - Damian Hudziak
AU - Rafał Wolny
AU - Adam Kowalówka
AU - Grzegorz Smolka
AU - Grzegorz Sobieszek
AU - Wojciech Wojakowski
AU - Wojciech Wańha
PY - 2026
DA - 2026/09/01
JO - Postepy w kardiologii interwencyjnej = Advances in interventional cardiology
DO - 10.5114/aic.2026.164719
UR - https://europepmc.org/article/PMC/PMC13721073
AB - Introduction: Drug-coated balloons (DCB) and drug-eluting stents (DES) are established options for coronary in-stent restenosis (ISR); evidence on sex-specific outcomes remains limited. Aim: To determine whether sex modifies the comparative effectiveness of DCB versus thin-strut, second-generation DES in ISR. Material and methods: Retrospective analysis of 1,317 patients undergoing percutaneous coronary intervention for ISR, 2008–2021. Because 57.6% were censored before 3 years, the primary estimand is the difference in restricted mean survival time (RMST) over 0–3 years for the device-oriented composite endpoint (DOCE). Counterfactual survival was estimated by weighted Kaplan–Meier estimation with entropy-balancing weights within each sex stratum; variance was estimated using bootstrap resampling pooled across 20 imputed datasets by Rubin’s rules. Results: Among 395 (30.0%) women and 922 (70.0%) men, 209 DOCE events accrued. Median observation time differed approximately twofold between arms (20.6 vs. 38.7 months in women; 19.7 vs. 39.4 months in men). The RMST difference was –0.047 years (95% CI: –0.579 to +0.486) in women and +0.036 (–0.186 to +0.259) in men, a sex difference of –0.083 years (–0.661 to +0.495; p = 0.78); weighted HRs were 0.76 (0.43–1.34) and 0.73 (0.50–1.07), respectively. No secondary endpoint showed heterogeneity: every uncorrected p exceeded 0.5 and every false-discovery-rate-adjusted value equalled 0.82. Cardiovascular deaths were similar between arms in women (5 vs. 5) and men (16 vs. 15); weighted HRs for all-cause mortality were 1.03 (0.39–2.72) and 0.78 (0.42–1.46), respectively. Conclusions: Sex did not modify the comparative effectiveness of DCB versus thin-strut DES for ISR, on the composite endpoint or on any component; these data do not support sex-based device selection. Wide intervals and differential follow-up establish the absence of detectable heterogeneity rather than equivalence.
SN - 1734-9338
SN - 1897-4295
ER -