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3-Year Outcomes of Low-Dose vs High-Dose Drug-Coated Balloons in Femoropopliteal Artery Disease: The PROSPECT MONSTER
Tatsuya Nakama1, Mitsuyoshi Takahara2, Yo Iwata3
1Department of Cardiology, Tokyo Bay Medical Center, Urayasu, Japan; Division of Vascular Surgery, Department of Surgery, The Jikei University School of Medicine, Tokyo, Japan.
Insights
Second-generation low-dose drug-coated balloons (LD-DCB) show comparable 3-year outcomes to high-dose drug-coated balloons (HD-DCB) for femoropopliteal artery disease. This supports LD-DCB as a viable treatment option with potentially lower drug exposure.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Device Technology
Background:
- Limited long-term data exist comparing low-dose drug-coated balloons (LD-DCB) and high-dose drug-coated balloons (HD-DCB).
- Previous studies indicated comparable 1-year outcomes between LD-DCB and HD-DCB in real-world settings.
Purpose of the Study:
- To compare the 3-year clinical outcomes of second-generation LD-DCB (Ranger) versus first-generation HD-DCB (IN.PACT).
- To evaluate efficacy and safety in patients with symptomatic femoropopliteal artery (FPA) disease.
Main Methods:
- Prospective, multicenter study of 581 patients with FPA disease treated with LD-DCB or HD-DCB.
- Propensity score matching created 163 comparable sets for analysis.
- Primary endpoints included 3-year primary patency and freedom from revascularization; secondary endpoints assessed limb events and survival.
Main Results:
- At 3 years, primary patency (60.1% vs 48.4%) and freedom from revascularization (71.0% vs 59.9%) were similar between LD-DCB and HD-DCB groups.
- No significant differences were observed in secondary outcomes, including major adverse limb events, limb salvage, and overall survival.
- No baseline characteristics interacted significantly with 3-year restenosis.
Conclusions:
- Second-generation LD-DCB demonstrated comparable 3-year clinical outcomes to first-generation HD-DCB in a real-world complex FPA disease population.
- These findings support LD-DCB as a reasonable treatment option, achieving similar efficacy with potentially lower paclitaxel exposure.
- The study highlights the potential of reduced-dose drug delivery in achieving comparable long-term results for FPA interventions.
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%]; HR: 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.
