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

NCT04496544 | Completed FDA Device

• 1 other identifier: 2019P000950
• Study Type: observational
• Target: 168,553
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Paclitaxel Adverse Reaction; Safety Issues

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Repeat hospitalization

  1, 2 and 3 years after index procedure

• Repeat endovascular or surgical revascularization

  1, 2 and 3 years after index procedure

• Target vessel revascularization

  1, 2 and 3 years after index procedure

• Lower extremity amputation

  1, 2 and 3 years after index procedure

• Optimal medical therapy

  1, 2 and 3 years after index procedure

Study Arms (2)

Drug-Coated Devices

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

Non-Drug-Coated Devices

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

Interventions

Retrospective data collection OTHER

No intervention; retrospective data collection

Drug-Coated Devices; Non-Drug-Coated Devices

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Medtronic: collaborator
• Philips Healthcare: collaborator
• Bard Peripheral Vascular, Inc.: collaborator
• Boston Scientific Corporation: collaborator
• Cook Medical: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• Secemsky EA, Song Y, Schermerhorn M, Yeh RW. Update From the Longitudinal Assessment of Safety of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices Among Medicare Beneficiaries: The SAFE-PAD Study. Circ Cardiovasc Interv. 2022 Jun;15(6):e012074. doi: 10.1161/CIRCINTERVENTIONS.122.012074. Epub 2022 May 20. No abstract available.

  PMID: 35593638 DERIVED

• Secemsky EA, Raja A, Shen C, Valsdottir LR, Schermerhorn M, Yeh RW; SAFE-PAD Investigators. Rationale and Design of the SAFE-PAD Study. Circ Cardiovasc Qual Outcomes. 2021 Jan;14(1):e007040. doi: 10.1161/CIRCOUTCOMES.120.007040. Epub 2021 Jan 13.

  PMID: 33435732 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Eric A Secemsky, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• Robert W Yeh, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: July 1, 2020
• Primary Completion: March 19, 2024
• Study Completion: June 30, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)