{ "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.\n\nAim: To determine whether sex modifies the comparative effectiveness of DCB versus thin-strut, second-generation DES in ISR.\n\nMaterial 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.\n\nResults: 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.\n\nConclusions: 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.", "abstract_shown": true, "affiliations": [ "Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Cracow University, Krakow, Poland", "Department of Cardiology, Holy Spirit Specialist Hospital, Sandomierz, Poland", "Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland", "DCB Academy, Cleveland, USA", "Department of Invasive Cardiology, Medical University of Bialystok, Poland", "Institute of Heart Diseases, University Hospital, Wroclaw Medical University, Wroclaw, Poland", "1 Department of Cardiology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland", "2 Department of Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland", "Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland", "Department of Cardiology, National Medical Institute of the Ministry of the Interior and Administration, Warsaw, Poland", "Department of Cardiac Surgery and Transplantology, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Poland", "Cardiac Catheterization Laboratory, Voivode Hospital in Bełchatow, Poland", "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", "Division of Cardiology, Department of Internal Medicine, Città della Salute e della Scienza, University of Turin, Italy", "Department of Cardiac Surgery, Medical University of Silesia, Katowice, Poland", "Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland", "Department of Cardiology, School of Health Sciences, Medical University of Silesia, Katowice, Poland", "Department of Cardiology, 1 Military Clinical Hospital, John Paul II Catholic University of Lublin, Poland" ], "article_type": "research article", "arxiv": null, "author_total": 29, "authors": [ { "affs": [ 0 ], "name": "Rafał Januszek" }, { "affs": [ 1 ], "name": "Michał Tarnowski" }, { "affs": [ 2 ], "name": "Paweł Pawlus" }, { "affs": [ 3 ], "name": "Sylwia Iwańczyk" }, { "affs": [ 4 ], "name": "Łukasz Kuźma" }, { "affs": [ 5 ], "name": "Brunon Tomasiewicz" }, { "affs": [ 5 ], "name": "Piotr Kubler" }, { "affs": [ 6 ], "name": "Maciej Wybraniec" }, { "affs": [ 6 ], "name": "Krystian Wita" }, { "affs": [ 4 ], "name": "Sławomir Dobrzycki" }, { "affs": [ 7 ], "name": "Stanisław Bartuś" }, { "affs": [ 8 ], "name": "Maciej Lesiak" }, { "affs": [ 9 ], "name": "Robert J. Gil" }, { "affs": [ 2 ], "name": "Marta Chamera" }, { "affs": [ 9 ], "name": "Tomasz Pawłowski" }, { "affs": [ 10 ], "name": "Mariusz Kowalewski" }, { "affs": [ 11 ], "name": "Damian Grzegorek" }, { "affs": [ 5 ], "name": "Fecehauwe Mezque" }, { "affs": [ 12 ], "name": "Agata Stanek" }, { "affs": [ 3 ], "name": "Filippo Luca Gurgoglione" }, { "affs": [ 3 ], "name": "Bernardo Cortese" }, { "affs": [ 13 ], "name": "Fabrizio D’Ascenzo" }, { "affs": [ 14 ], "name": "Damian Hudziak" }, { "affs": [ 15 ], "name": "Rafał Wolny" }, { "affs": [ 14 ], "name": "Adam Kowalówka" }, { "affs": [ 16 ], "name": "Grzegorz Smolka" }, { "affs": [ 17 ], "name": "Grzegorz Sobieszek" }, { "affs": [ 2 ], "name": "Wojciech Wojakowski" }, { "affs": [ 2 ], "name": "Wojciech Wańha" } ], "bibtex": "https://research.draconitic.com/paper/7jdrtpawgq0xt.bib", "cited_by": 0, "doi": "10.5114/aic.2026.164719", "fulltext_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13721073/?tool=EBI", "id": "7jdrtpawgq0xt", "issns": [ "1734-9338", "1897-4295" ], "landing_url": "https://europepmc.org/article/PMC/PMC13721073", "language": "eng", "licence": "CC-BY-NC-SA", "licence_label": "CC BY-NC-SA", "licence_source": "article", "licence_url": "https://creativecommons.org/licenses/by-nc-sa/4.0/", "metadata_licence": null, "native_subjects": [ [ "heading", "Original Paper" ], [ "openalex", "2746|Coronary Interventions and Diagnostics" ] ], "openalex": "W7213229674", "pdf_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13721073/pdf/?tool=EBI", "pmcid": "PMC13721073", "pmid": "42964684", "published": "2026-09-01", "publisher": "Termedia Publishing", "ris": "https://research.draconitic.com/paper/7jdrtpawgq0xt.ris", "sources": [ { "first_seen": "2026-10-31T12:21:37Z", "native_id": "PMC:PMC13721073", "source": "europepmc", "url": "https://europepmc.org/article/PMC/PMC13721073" }, { "first_seen": "2026-11-03T12:21:49Z", "native_id": "PMC13721073", "source": "pmc", "url": "https://doi.org/10.5114/aic.2026.164719" } ], "subjects": [ { "field": "medicine", "origin": "openalex:2746|Coronary Interventions and Diagnostics", "subfield": "surgery" } ], "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)", "title_text": "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)", "type": "peer-reviewed", "updated_at": "2026-11-03T12:21:49Z", "url": "https://research.draconitic.com/paper/7jdrtpawgq0xt", "venue": "Postepy w kardiologii interwencyjnej = Advances in interventional cardiology", "versions": [] }