The SAFE-PAD Study aims to evaluate the long-term safety of paclitaxel-coated devices compared with non-paclitaxel-coated devices for femoropopliteal artery revascularization among a broad, real-world population of patients with peripheral artery disease. This multi-year analysis aims to create an ongoing mechanism to evaluate the safety of paclitaxel-coated devices in real world practice. The null hypothesis is that the paclitaxel-coated devices are associated with an increase in mortality relative to the non-drug-coated devices beyond an acceptable magnitude (i.e. the non-inferiority margin), and the alternative hypothesis is that paclitaxel-coated devices are not associated with an increase in mortality relative to the non-drug-coated devices beyond the non-inferiority margin.

This is an observational retrospective cohort study using claims data to evaluate the long-term safety of paclitaxel-coated devices compared with non-drug coated devices for femoropopliteal artery revascularization, with median follow-up time for the population surpassing 5 years. A series of supplemental sensitivity analyses will be conducted to assess and mitigate the potential for unmeasured confounding and to determine the impact of repeat interventions and paclitaxel exposure on survival. Finally, sub-group analyses will be performed to investigate whether there is differential safety of paclitaxel-coated devices across different patient profiles.

Inclusion Criteria:

• All fee-for-service Medicare beneficiaries who underwent femoropopliteal artery revascularization. Patients are allowed to undergo simultaneous revascularization of lesions outside this target vessel during the same procedure.
• All patients with ≥1 year of Medicare claims data prior to their index procedure.

Exclusion Criteria:

• Patients without 1 year of Medicare claims data prior to their index revascularization procedure.
• Patients that do not have both a carrier file charge and an institutional file charge on the date of an outpatient procedure. This removes procedures performed in certain clinical settings, such as office-based clinics, that do not submit the Healthcare Common Procedure Coding System (HCPCS) code needed to identify drug-coated devices.

The study cohort will include all Medicare fee-for-service beneficiaries who underwent femoropopliteal artery revascularization with either drug-coated devices (drug-eluting stent [DES] ± drug-coated balloon [DCB], bare metal stent [BMS] with DCB, or DCB alone) or non-drug-coated devices (BMS ± percutaneous transluminal angioplasty [PTA] or PTA alone). Each group will additionally be composed of two device-specific subgroups: a DCB sub-group and DES sub-group in the drug-coated group, and a PTA sub-group and a BMS sub-group in the non-drug group.

As restricted by the data use agreement with the Centers for Medicare and Medicaid Services (CMS), we will not allow any data sharing for this project and we will not make any distribution of the CMS data.