Aortic & peripheral vascular disease
3-Year Outcomes of Low-Dose vs High-Dose Drug-Coated Balloons in Femoropopliteal Artery Disease: The PROSPECT MONSTER Study
Authors' conclusion
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.
Study context
- Population
- Patients undergoing endovascular therapy for symptomatic femoropopliteal artery (FPA) diseasematched: 358 low-dose drug-coated balloon (LD-DCB) and 163 high-dose drug-coated balloon (HD-DCB) · LD-DCB 370 · HD-DCB 211
- Participants
- 581 patients
- Exposure
- LD-DCB vs HD-DCB
- LD-DCBn = 370
- HD-DCBn = 211reference
- Outcome
- Primary patency and freedom from clinically driven target lesion revascularization
- Follow-up
- 3 years
Methodological detailspropensity score matching
- Propensity score matching
Main finding
As reported in the abstract
LD-DCB
- Primary patency
- 60.1% [95% CI: 53.1%-67.9%]
- Freedom from clinically driven target lesion revascularization
- 71.0% [64.7%-77.9%]
HD-DCB
- Primary patency
- 48.4% [39.3%-59.7%]
- Freedom from clinically driven target lesion revascularization
- 59.9% [50.8%-70.7%]
Primary patency
LD-DCB60.1% [95% CI: 53.1%-67.9%]
HD-DCB48.4% [39.3%-59.7%]
Freedom from clinically driven target lesion revascularization
LD-DCB71.0% [64.7%-77.9%]
HD-DCB59.9% [50.8%-70.7%]
LD-DCB vs HD-DCBHazard ratio (CI)P value
Primary patency
1.02(0.60–1.73)
P = 0.93Freedom from clinically driven target lesion revascularization
1.02(0.58–1.81)
P = 0.94Observational data: associations, not effects.
Secondary outcomes
Secondary outcomes (major adverse limb events, limb salvage, overall survival)
- Secondary outcomes were comparable
Interaction of baseline characteristics with 3-year restenosis
- No baseline characteristics showed a significant interaction with 3-year restenosis
Follow-up
Months
- Median follow-up
- 19.9 (IQR: 9.4-37.7)
- Median follow-up among matched participants
- 19.9 (9.2-37.9)
Original publication
3-Year Outcomes of Low-Dose vs High-Dose Drug-Coated Balloons in Femoropopliteal Artery Disease: The PROSPECT MONSTER Study. JACC Adv. Published 14 August 2026. doi:10.
Summarised from the published abstract; every number is checked against it