3-Year Outcomes of Low-Dose vs High-Dose Drug-Coated Balloons in Femoropopliteal Artery Disease: The PROSPECT MONSTER Study.

BACKGROUND: In the PROSPECT MONSTER study, LD-DCB demonstrated comparable 1-year outcomes to HD-DCB in a real-world population; however, long-term comparative data remain limited. OBJECTIVES: To compare 3-year outcomes of a second-generation low-dose drug-coated balloon (LD-DCB; Ranger) vs a first-generation high-dose drug-coated balloon (HD-DCB; IN.PACT) in symptomatic femoropopliteal artery (FPA) disease. METHODS: This prospective, multicenter, study included 581 patients undergoing endovascular therapy with LD-DCB (n = 370) or HD-DCB (n = 211) for FPA disease. Median follow-up was 19.9 (IQR: 9.4-37.7) months. Primary outcomes were 3-year primary patency and freedom from clinically driven target lesion revascularization, assessed after propensity score matching. Secondary outcomes included major adverse limb events, limb salvage, and overall survival. RESULTS: Propensity score matching in an approximate 2:1 ratio extracted 163 matched sets (358 and 163 patients in LD-DCB and HD-DCB, respectively) with no significant baseline differences. The median follow-up among matched participants was 19.9 (9.2-37.9) months. At 3 years, primary patency (60.1% [95% CI: 53.1%-67.9%] vs 48.4% [39.3%-59.7%]; HR: 1.02 [0.60-1.73], P = 0.93) and freedom from clinically driven target lesion revascularization (71.0% [64.7%-77.9%] vs 59.9% [50.8%-70.7%]; hazard ratio: 1.02 [0.58-1.81], P = 0.94) were similar between groups. Secondary outcomes were comparable. No baseline characteristics showed a significant interaction with 3-year restenosis. CONCLUSIONS: In a real-world population with complex FPA disease, second-generation LD-DCB demonstrated 3-year clinical outcomes comparable to those of first-generation HD-DCB. These findings support the use of second-generation LD-DCB as a reasonable treatment option and suggest that comparable efficacy may be achieved despite substantially lower paclitaxel exposure.