Abstract
BACKGROUND: Percutaneous coronary intervention (PCI) for true bifurcation lesions remains a significant challenge. PCI with drug-eluting stents presents challenges associated with metallic stents, such as branch occlusion, stent layers, and procedural complexity in bifurcation PCI. In contrast, stentless PCI using a drug-coated balloon (DCB) eliminates stent-related complexities. However, the outcomes of this approach remain unclear. This study aimed to evaluate the 1-year clinical outcomes of stentless PCI using DCB for de novo true bifurcation lesions. METHODS: This multicenter retrospective study enrolled patients with coronary artery disease who underwent PCI for de novo true bifurcation lesions using DCB without stent placement between January 2019 and March 2022. A total of 35 patients with lesions were analyzed. RESULTS: Among the analyzed lesions, 45.7% were classified as Medina 1,1,1, and 48.5% exhibited moderate or greater calcification. Debulking devices were employed in 65.7% of cases. The 1-year Kaplan-Meier estimate of freedom from target vessel failure was 87.3% (95% CI, 69.4-95.1), whereas the estimate for target vessel revascularization was 92.6% (95% CI, 73.5-98.1). No side branch flow disturbance related to DCB use was observed. The minimal lumen diameter and percent diameter stenosis of the main target vessel improved following the PCI procedure and remained stable for a mean duration of 11.2 ± 7.5 months without compromising the side branch. CONCLUSIONS: Stentless PCI using DCB for de novo true bifurcation lesions demonstrated acceptable 1-year clinical outcomes.