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

Completed

• Conditions: Peripheral Arterial Disease; Paclitaxel Adverse Reaction; Safety Issues
• Interventions: Other: Retrospective data collection

• Registration Number: NCT04496544
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-03
• Primary Completion: 2024-03-19
• Study Completion: 2024-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168553

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Drug-Coated Devices	Retrospective data collection	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)
Drug-Coated Devices	Retrospective data collection	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)

Primary Outcome Measures

Name	Time	Method
All-cause mortality	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	All-cause mortality of patients who underwent femoropopliteal artery revascularization with drug-coated devices or non-drug-coated devices

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States