Safety Assessment of Femoropopliteal Endovascular Treatment With PAclitaxel-coated Devices (SAFE-PAD Study)

Beth Israel Lahey Health

Status: Completed

Conditions: Safety Issues; Paclitaxel Adverse Reaction; Peripheral Arterial Disease

Treatments: Other: Retrospective data collection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04496544

2019P000950

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 168,553 patients

Sex: All

Ages: 66+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

168,553 participants in 2 patient groups

Drug-Coated Devices

Description:

Medicare fee-for-service beneficiaries who underwent femoropopliteal artery revascularization with drug-coated devices (drug-eluting stent ± drug-coated balloon, bare metal stent with drug-coated balloon, or drug-coated balloon alone)

Treatment:

Other: Retrospective data collection

Non-Drug-Coated Devices

Description:

Medicare fee-for-service beneficiaries who underwent femoropopliteal artery revascularization with non-drug-coated devices (bare metal stent ± percutaneous transluminal balloon angioplasty or percutaneous transluminal balloon angioplasty alone)

Treatment:

Other: Retrospective data collection