Drug-Coated Balloon Percutaneous Coronary Intervention in Diabetic and Non-Diabetic Patients: A Large All-Comers Cohort of Mid-Term Outcomes and Predictors of Adverse Events

Background: Diabetes accelerates atherosclerosis and restenosis and impairs vascular healing, complicating percutaneous coronary intervention (PCI). Drug-coated balloons (DCBs) deliver antiproliferative therapy without a permanent scaffold, but their comparative mid-term performance in diabetic patients relative to non-diabetic patients is incompletely defined. Methods: We analysed a large all-comers cohort of consecutive patients who underwent a DCB-based PCI between 2018 and 2022, stratified by diabetes status. The primary endpoint was a composite of cardiac death, target vessel revascularisation (TVR) and target vessel myocardial infarction. Cumulative incidence was estimated by Kaplan–Meier analysis, and predictors were assessed by Cox regression. Results: Among 853 patients (304 diabetic, 549 non-diabetic), diabetic patients had more comorbidities and more frequent in-stent restenosis (52.3% vs. 41.8%). Over a median follow-up of 376 days, the two-year incidence of the composite endpoint was higher among diabetic patients (21.3% vs. 10.6%, p = 0.007), as was target lesion revascularisation (TLR; 13.6% vs. 5.5%, p = 0.004). Diabetes independently predicted the composite endpoint (adjusted hazard ratio: 1.87; 95% CI: 1.10–3.17) and TLR (adjusted HR: 2.33; 95% CI: 1.18–4.62), whereas DCB type and procedural variables did not. Conclusions: In an all-comers DCB-PCI population, diabetes was independently associated with higher rates of mid-term major adverse cardiovascular events and target lesion revascularisation, while device and procedural variables did not drive outcomes, underscoring the importance of systemic risk management in regard to diabetic patients.