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)
Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Cracow University, Krakow, Poland
Cardiac Catheterization Laboratory, Voivode Hospital in Bełchatow, Poland
Cardiac Catheterization Laboratory, University Hospital in Radomsko, Poland
Cardiac Catheterization Laboratory, American Heart of Poland, Chrzanow, 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 Cardiology, Poznan University of Medical Sciences, Poznan, Poland
Department of Invasive Cardiology, Medical University of Bialystok, Poland
Institute of Heart Diseases, University Hospital, Wroclaw Medical University, Wroclaw, Poland
1st Department of Cardiology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland
2nd Department of Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Krakow, 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
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, Parma University Hospital, Parma, Italy
Fondazione Ricerca e Innovazione Cardiovascolare, Milano, Italy
University Hospitals Harrington Heart and Vascular Institute, Cleveland, OH, USA
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, 1st Military Clinical Hospital, John Paul II Catholic University of Lublin, Poland
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.
Keywords
percutaneous coronary intervention, sex, drug-eluting stent, in-stent restenosis, long-term outcomes, drug-coated balloon
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