Sex-based differences in patients on oral anticoagulation undergoing percutaneous coronary intervention with drug-eluting stents: a subgroup analysis of the PERSEO registry

Background Previous observational studies have shown that women undergoing percutaneous coronary intervention (PCI) are generally older and have a higher burden of comorbidities than men, and exhibit higher unadjusted rates of adverse events after PCI. Purpose To investigate sex-based differences in clinical outcomes among patients on long-term oral anticoagulation (OAC) undergoing PCI with drug-eluting stent (DES) implantation. Methods The PERSEO registry is a prospective, multicentre, observational study conducted at 25 Italian centres, enrolling consecutive patients on OAC for atrial fibrillation, venous thromboembolism, left ventricular thrombus, mechanical heart valves, or other indications, undergoing PCI with DES implantation. Pharmacological and interventional management was left to operator discretion. The primary outcome was net adverse clinical events (NACE), defined as the composite of major adverse cardiac and cerebrovascular events (MACCE) and major bleeding. MACCE included all-cause death, non-fatal myocardial infarction (MI), stent thrombosis, urgent/unplanned target vessel revascularization (TVR), and non-fatal stroke/transient ischaemic attack (TIA). Secondary outcomes, including MACCE, all-cause death, cardiac death, non-fatal MI, non-fatal stroke/TIA, TVR, and major and clinically relevant bleeding were also compared. Multivariable Cox analysis was adjusted for predictors of NACE including Body Mass Index, Charlson score, CHA2DS2VASc, HAS-BLED, chronic kidney disease, anaemia, type of OAC (direct oral anticoagulants/vitamin K-antagonists), and duration of the initial triple antithrombotic therapy. Results Among 1234 enrolled patients, women (n=333, 27%) were older and had higher thromboembolic and bleeding risk profiles, whereas men (n=901) more frequently had prior ischaemic heart disease and smoking history. NACE occurred in 26% of women and 21.3% of men (p=0.084; log-rank p=0.129). Similarly, MACCE rates were comparable(16.2% vs 13.3%, p=0.189). Women had higher rates of all-cause (14.1% vs 9.4%, p=0.020) and cardiac (6.4% vs 3.1%, p=0.010) death, while other ischaemic and bleeding outcomes did not differ significantly. In univariable analysis, male sex was associated with lower all-cause and cardiac mortality; however, after multivariable adjustment, sex was not independently associated with NACE, MACCE, mortality, ischaemic, or bleeding events. Conclusions Among patients on OAC undergoing PCI with DES, women presented with a higher baseline risk profile and higher unadjusted mortality. However, after adjustment for confounding factors, sex was not an independent predictor of ischaemic or bleeding outcomes, suggesting that baseline clinical differences rather than sex per se drive outcome disparities.