The Role of Drug-Coated Balloons in an All-Comer Population: Outcomes from a Two-Center Real-World Registry

Background and Objectives: Drug-coated balloons (DCBs) represent a novel, attractive strategy for coronary revascularization; however, data supporting their use in complex real-world populations remain limited. We aimed to evaluate the safety and efficacy of a DCB-first strategy in a predominantly acute coronary syndrome (ACS) and multivessel disease (MVD) population. Materials and Methods: We conducted a prospective two-center observational registry including 115 consecutive patients treated with a DCB-first strategy (DCB-only in 44 patients and a hybrid DCB-drug-eluting stent in 71 patients) for both de novo and in-stent coronary lesions. Bailout stenting was performed when required according to predefined criteria. Results: The study population was characterized by high clinical complexity, with 78.3% MVD and 67.8% presenting with ACS, including 10.5% ST-segment elevation myocardial infarctions. Bailout stenting was required in 12.2% of lesions. At 18 months, the target lesion revascularization (TLR) rate was 2.83%, while the device-oriented composite endpoint (DOCE; cardiac death, target vessel myocardial infarction or TLR) occurred in 4.7% of patients. The cumulative major adverse cardiovascular event (MACE) rate at 18 months was 14.8%, largely driven by the high-risk clinical profile of the cohort. Patients treated with a DCB-only strategy had a shorter duration of dual antiplatelet therapy compared with those treated with a hybrid strategy. Conclusions: In this two-center real-world registry including predominantly ACS and MVD patients, a DCB-first strategy was associated with low lesion-level event rates and acceptable mid-term clinical outcomes. These findings support the feasibility of a leave-nothing-behind approach in complex coronary disease when meticulous lesion preparation and provisional bailout stenting are applied.