Key result
Femoropopliteal drug-coated devices show noninferior long-term mortality compared to non-drug-coated devices.
Why the study?
Does the use of drug-coated devices increase long-term mortality in older patients undergoing femoropopliteal artery revascularization?
Cohort (n=168,553)
Yes
Does the use of drug-coated devices increase long-term mortality in older patients undergoing femoropopliteal artery revascularization?
Hazard Ratio: 0.98 (95% CI 0.97–0.99)
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Although restenosis, patency, and TLR remain important procedural outcomes, patients and clinicians are ultimately concerned with limb preservation, symptom relief, and avoidance of repeat interventions. The SirPAD trial findings demonstrate that the benefits of DCB technology can translate into...”
In a large, real-world Medicare cohort, the use of drug-coated devices for femoropopliteal revascularization was safe and not associated with an increased risk of long-term mortality, supporting the reversal of regulatory warnings.
Background and Aims Femoropopliteal artery disease is associated with high rates of post-revascularization restenosis. Drug-coated devices (DCD), including drug-coated balloons (DCBs) and drug-eluting stents (DES), have demonstrated efficacy in reducing restenosis rates compared to non-drug-coated devices (NDCDs). However, concerns about potential long-term mortality risks have led to regulatory scrutiny. This study represents the final report from the Safety Assessment of Femoropopliteal Endovascular Treatment with Paclitaxel-Coated Devices (SAFE-PAD) study, a pre-specified analysis designed with the US Food and Drug Administration to evaluate the long-term mortality associated with femoropopliteal DCD use. Methods SAFE-PAD was a retrospective cohort study of 168 553 Medicare fee-for-service beneficiaries (≥66 years) who underwent femoropopliteal artery revascularization between 2015 and 2018. Device exposure (DCDs vs. NDCDs) was identified using Medicare claims data. The primary outcome was all-cause mortality, assessed between treatment groups using inverse probability treatment weighting. Secondary outcomes included all-cause hospitalizations, repeat revascularization, major amputation, and cardiovascular medication use. Sensitivity analyses included instrumental variable methods, falsification endpoints, and simulation of hypothetical unmeasured confounders. Subgroup analyses examined outcomes in inpatient vs outpatient settings, in younger/low-risk populations, and in high-risk chronic limb-threatening ischaemia patients. Results At a median follow-up of 4.3 years (maximum: 9.0 years), DCD use was not associated with increased mortality (adjusted hazard ratio: 0.98; 95% confidence interval: 0.97, 0.99), meeting the pre-specified 5% non-inferiority relative margin. Sensitivity analyses supported the validity of the primary result. Secondary outcomes showed similar hospitalization and amputation rates between groups but an increase in repeat revascularization with DCDs. Subgroup analyses confirmed safety findings across high/low-risk subgroups and across clinical settings. Conclusions 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. The SAFE-PAD study helped inform the reversal of regulatory warnings against routine DCD use.
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Kim et al. (2025) conducted a cohort in Femoropopliteal artery disease (n=168,553). Drug-coated devices vs. Non-drug-coated devices was evaluated on All-cause mortality (adjusted HR 0.98, 95% CI 0.97-0.99). Drug-coated devices for femoropopliteal revascularization were noninferior to non-drug-coated devices for long-term mortality (adjusted HR 0.98; 95% CI 0.97-0.99), meeting the 5% margin.
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