Comparison of High-Dose versus Low-Dose Paclitaxel Drug-Coated Balloons for Native Femoropopliteal Artery Disease: An Analysis of the K-VIS ELLA Registry

Purpose: Drug-coated balloons (DCBs) have demonstrated favorable outcomes in the treatment of femoropopliteal artery (FPA) disease. A variety of DCBs are currently available, with differing doses of antiproliferative agents and types of excipients. The objective of this study was to compare the efficacy and safety of high-dose versus low-dose paclitaxel DCBs for the treatment of FPA disease. Materials and Methods: We analyzed data from the multicenter the Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases (K-VIS ELLA) registry, focusing on patients treated with a high-dose paclitaxel DCB (IN.PACT™) or lowdose paclitaxel DCB (Lutonix™ or Ranger™) for native vessel FPA disease. We used inverse probability of treatment weighting to adjust for confounding factors and conducted subgroup analyses based on lesion characteristics. Results: Among 820 target limbs, 626 were treated with a high-dose paclitaxel DCB, and 194 were treated with a low-dose paclitaxel DCB. At 12 months, there were no significant differences in rates of freedom from clinically driven target lesion revascularization (TLR; 91.7% vs. 89.4%, log-rank p=0.35), major adverse limb event (MALE; 91.4% vs. 89.0%, log-rank p=0.31), or all-cause mortality (93.1% vs. 93.8%, log-rank p=0.79) between high-dose and low-dose groups. On multivariable analysis, the presence of chronic heart failure and chronic kidney disease were the only independent predictors of clinically driven TLR after DCB treatment. Conclusion: In this multicenter cohort study of patients with complex FPA disease, there were no significant differences between high-dose DCB and low-dose DCB with respect to freedom from clinically driven TLR, MALE, or all-cause mortality at 12-month follow-up.