Efficacy and Safety of Drug-Coated vs. Standard Balloons in Coronary Bifurcation Lesions

Abstract

Objectives: This study evaluated the efficacy and safety of drug-coated balloons (DCBs) compared to standard balloons in the provisional stenting of coronary bifurcation lesions. Methodology: A prospective, two-arm interventional trial was conducted involving 66 patients with Medina (1,1,1), (1,0,1), or (0,1,1) bifurcation lesions at multiple centers in Cairo, Egypt, from December 2021 to October 2023. Patients were assigned to Group A (n = 40, standard balloons) or Group B (n = 26, DCB therapy), with both groups receiving drug-eluting stents (DES) in the main vessel. Lesion dimensions and procedural outcomes were assessed using quantitative coronary angiography (QCA). Primary endpoints included lesion success, procedural success, and safety outcomes. Results: DCBs significantly improved acute lumen gain in side branches (2.96 ± 0.82 mm vs. 2.00 ± 0.69 mm, p < 0.05) and reduced fluoroscopy time (51.31 ± 28.12 minutes vs. 69.33 ± 29.10 minutes, p < 0.05). While procedural success rates were comparable, the need for a second stent was significantly higher in the standard balloon group (20% vs. 0%, p < 0.05). There were no significant differences in major adverse cardiac events or in-hospital complications between the two groups. Conclusion: DCBs demonstrated superior efficacy in side branch protection, reduced restenosis, and simplified procedural complexity while maintaining comparable safety to standard balloons. These findings highlight the potential of DCBs as an effective alternative in the treatment of coronary bifurcation lesions.