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

• ClinicalTrials.gov Identifier: NCT04496544
• Recruitment Status: Active, not recruiting
• First Posted: August 3, 2020
• Last Update Posted: May 6, 2023
• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Medtronic; Philips Healthcare; Bard Peripheral Vascular, Inc.; Boston Scientific Corporation; Cook Medical
• Information provided by (Responsible Party): Eric Secemsky, Beth Israel Deaconess Medical Center

Tracking Information

• First Submitted Date: July 29, 2020
• First Posted Date: August 3, 2020
• Last Update Posted Date: May 6, 2023
• Actual Study Start Date: July 1, 2020
• Estimated Primary Completion Date: June 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 31, 2020)

All-cause mortality [ Time Frame: 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 31, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety Assessment of Femoropopliteal Endovascular Treatment With PAclitaxel-coated Devices (SAFE-PAD Study)
• Official Title: Safety Assessment of Femoropopliteal Endovascular Treatment With PAclitaxel-coated Devices (SAFE-PAD Study)
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Peripheral Arterial Disease
• Paclitaxel Adverse Reaction
• Safety Issues

Intervention

Other: Retrospective data collection

No intervention; retrospective data collection

Study Groups/Cohorts

• 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)
  Intervention: 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)
  Intervention: Other: Retrospective data collection

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: July 31, 2020): 250000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: June 30, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 66 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04496544
• Other Study ID Numbers: 2019P000950
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: 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.

• Current Responsible Party: Eric Secemsky, Beth Israel Deaconess Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Beth Israel Deaconess Medical Center
• Original Study Sponsor: Same as current

Collaborators

• Medtronic
• Philips Healthcare
• Bard Peripheral Vascular, Inc.
• Boston Scientific Corporation
• Cook Medical

Investigators

• Principal Investigator: Eric A Secemsky, MD; Beth Israel Deaconess Medical Center
• Principal Investigator: Robert W Yeh, MD; Beth Israel Deaconess Medical Center

• PRS Account: Beth Israel Deaconess Medical Center
• Verification Date: May 2023