Safety and effectiveness of drug-coated balloon angioplasty in de novo coronary lesions: 6-month outcomes from a multicenter registry

Drug-coated balloon (DCB) angioplasty has emerged as a promising alternative to drug eluting stent (DES) implantation, particularly in small-vessel coronary disease (defined as target vessels with a reference diameter ≤2.75 mm). Nevertheless, multicenter real-world data focusing exclusively on de novo lesions remain limited. To evaluate procedural success, safety profile, and effectiveness of DCB angioplasty in de novo coronary lesions with 6-month clinical follow-up. This prospective observational registry included 156 consecutive patients who underwent percutaneous coronary intervention (PCI) with DCB for de novo coronary lesions between June 2024 and August 2025 across three tertiary cardiac centers. Clinical follow-up was performed at 1, 3, and 6 months post-procedure to record major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation. Procedural success was defined as fulfillment of all the following: device success and freedom from in-hospital cardiovascular death or target lesion revascularization or peri-procedural myocardial infarction (MI) or any stroke or BARC 3–5 bleeding, or the need for bailout stenting. Optimal lesion preparation was defined as full balloon expansion (1:1 ratio), ≤30% residual stenosis, TIMI 3 flow and absence of flow-limiting dissection. The mean age was 67.9 ± 10.8 years; 86.1% were men and 32% had diabetes mellitus. 8% presented with acute coronary syndrome. Target vessels included LAD (31.8%), LCx (21.6%), RCA (17.0%), D1 (12.5%) and others (17.1%). A total of 36 DCBs (18.4%) were implanted in side branches of bifurcation lesions, predominantly involving the left anterior descending (LAD)–diagonal and left circumflex–obtuse marginal (OM) branches. DCB diameters ranged from 2.0 mm to 2.75 mm (most commonly 2.5 mm [53%]) and lengths were 15 mm (49%), 25mm (22%), 30mm (14%), 20 mm (9%) and 10mm (6%). Sirolimus-coated balloons were used in 23.1% and paclitaxel-coated in 76.9%. Residual dissections occurred in all DCB-treated segments (n = 11/156), 3 of which were flow-limiting and required bailout stenting, while on the other hand 8 were non–flow-limiting and left untreated. Overall procedural success was 98%. At 6-month follow-up, the MACE rate was 5.7% (n = 9). DCB-based PCI achieved high procedural success and excellent in-hospital and mid-term safety across 3 tertiary centers. This strategy proved effective even in complex-and bifurcation-lesions while minimizing metal implantation. These findings reinforce the feasibility and growing adoption of a "leave-nothing-behind" approach in contemporary coronary intervention. Moreover, DCB-only angioplasty may allow shortening of dual antiplatelet therapy duration and represent a valuable alternative for patients at high bleeding risk.