Clinical outcomes of a drug-coated balloon-only strategy for de novo ACC/AHA type B2/C coronary lesions in large vessels: A propensity-matched comparison with drug-eluting stents.

BACKGROUND: Drug-coated balloons (DCB) have emerged as an alternative to drug-eluting stents (DES) in selected coronary lesions; however, their role in complex percutaneous coronary intervention (PCI), particularly in large vessels, remains unclear. OBJECTIVES: This study compared clinical outcomes between a DCB-only strategy performed after successful lesion preparation and DES implantation in patients with de novo ACC/AHA type B2/C coronary lesions in large vessels. METHODS: We conducted a retrospective single-center study of patients undergoing PCI for de novo complex lesions in large coronary vessels, defined as those with a reference vessel diameter ≥ 3.0 mm, between January 2018 and December 2023. Clinical outcomes were analyzed at the patient level using one predefined index lesion per patient. In the DCB group, the final decision to perform DCB-only PCI was made after successful lesion preparation, defined as TIMI grade 3 flow, residual stenosis <30%, and no major dissection. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization. Propensity score matching and additional Cox models stratified by matched pair were used to adjust for baseline differences and account for the matched design. RESULTS: Among 325 patients with 325 index lesions, 123 patients were treated with DCB-only PCI and 202 patients with DES implantation. Hybrid DCB-DES PCI cases were excluded from the analysis. After propensity score matching, 113 patients in each group were analyzed. During a mean follow-up of 1344.5 ± 725.9 days, TLF occurred in 5 of 113 patients in the DCB group and 11 of 113 patients in the DES group, corresponding to estimated 3-year cumulative incidences of 6.0% and 11.3%, respectively (hazard ratio, 0.48; 95% confidence interval, 0.17-1.36; log-rank P = 0.159). In multivariable analysis, DCB treatment was not independently associated with TLF (adjusted hazard ratio, 0.41; 95% confidence interval, 0.14-1.23; P = 0.11). CONCLUSIONS: In carefully selected de novo ACC/AHA type B2/C large-vessel coronary lesions judged suitable for DCB-only PCI after successful lesion preparation, a DCB-only strategy was not associated with a significant increase in TLF compared with DES implantation. These results are hypothesis-generating and do not establish equivalence or non-inferiority.