Comparing the Clinical Performance of High-Dose and Low-Dose Drug-Coated Balloons for Long Femoropopliteal Artery Disease: Results of the SATELLITE Study.

Background: Previous studies have shown comparable outcomes between first-generation high-dose drug-coated balloon (HD-DCB) and second-generation low-dose drug-coated balloon (LD-DCB) for femoropopliteal artery disease. However, data about the clinical performances of these DCBs for longer lesions in real-world clinical settings are limited.

Methods: In this multicenter, retrospective study, the clinical performances of the HD-DCB (IN.PACT, Medtronic, MN, USA) and the LD-DCB (Ranger, Boston, MA, USA) were assessed in cases of femoropopliteal artery disease with lesion length ≥ 150 mm. From the database, 288 lesions in 288 patients were assigned to the HD-DCB group, and 88 lesions in 88 patients were assigned to the LD-DCB group. Propensity score-matching analysis was performed to adjust for baseline patient and lesion characteristics. The primary outcome was the 2-year primary patency rate of the two types of DCBs.

Results: Propensity score matching was used to extract 76 pairs with no significant intergroup differences in baseline patient and lesion characteristics. The average lesion length was 257.5 and 255.7 mm in the HD and LD-DCB groups, respectively. The 2-year primary patency rates between the HD and LD-DCB groups were comparable (68.5% vs. 60.4%; p = 0.33). There were also no significant differences in clinically driven target lesion revascularization, acute limb ischemia, major amputation, or overall survival between the two types of DCBs.

Conclusion: The clinical outcomes between the HD and LD-DCBs did not significantly differ in real-world populations with severely complex lesions.