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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Peripheral Arterial Disease, Paclitaxel Adverse Reaction, Safety Issues

Intervention / Treatment
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* Other: Retrospective data collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Drug-Coated Devices<br>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) | Other: Retrospective data collection<br>* No intervention; retrospective data collection<br>|
| Non-Drug-Coated Devices<br>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) | Other: Retrospective data collection<br>* No intervention; retrospective data collection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause mortality of patients who underwent femoropopliteal artery revascularization with drug-coated devices or non-drug-coated devices | Time from index procedure date to the date of death, to be updated periodically until the median duration of follow-up for the cohort reaches 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeat hospitalization | Rates of repeat hospitalization | 1, 2 and 3 years after index procedure | 
| Repeat endovascular or surgical revascularization | Rates of repeat endovascular or surgical revascularization | 1, 2 and 3 years after index procedure | 
| Target vessel revascularization | Rates of target vessel revascularization among inpatient procedures | 1, 2 and 3 years after index procedure | 
| Lower extremity amputation | Rates of lower extremity amputation | 1, 2 and 3 years after index procedure | 
| Optimal medical therapy | Rates of optimal medical therapy | 1, 2 and 3 years after index procedure |