Aortic & peripheral vascular diseaseCohort study
Drug-coated vs non-drug-coated devices for femoropopliteal artery interventions: long-term outcomes of the SAFE-PAD study
- Retrospective cohort study
- pre-specified analysis designed with the US Food and Drug Administration
- inverse probability treatment weighting
- non-inferiority
Authors' conclusion
In this final report from the SAFE-PAD study, there was no evidence of long-term mortality risk associated with DCDs used for femoropopliteal revascularization.
Study context
- Population
- Medicare fee-for-service beneficiaries (≥66 years) undergoing femoropopliteal artery revascularization, 2015–2018
- Participants
- 168,553 beneficiaries
- Exposure
- Drug-coated devices (DCDs) vs non-drug-coated devices (NDCDs)
- Outcome
- All-cause mortality
- Follow-up
- Median 4.3 years (maximum 9.0 years)
Main finding
As reported in the abstract
median follow-up 4.3 years
Adjusted hazard ratio
0.98
95% CI 0.97–0.99
DCDs vs NDCDs
adjusted HR 0.98 (95% CI 0.97–0.99)
Observational data: associations, not effects.
Secondary outcomes
All-cause hospitalization, major amputation, repeat revascularization
- Similar hospitalization and amputation rates between groups
- Increase in repeat revascularization with DCDs
All-cause mortality, by subgroup (high/low risk, clinical setting)
- Safety findings confirmed across high/low-risk subgroups and across clinical settings
Original publication
Drug-coated vs non-drug-coated devices for femoropopliteal artery interventions: long-term outcomes of the SAFE-PAD study. Eur Heart J. Published 25 September 2025. doi:10.1093/eurheartj/ehaf721
Summarised from the published abstract; every number is checked against it