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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Safety Issues; Paclitaxel Adverse Reaction
• Intervention / Treatment: Other: Retrospective data collection

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
• Enrollment (Actual): 168553

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 66 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; No intervention; 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; No intervention; retrospective data collection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Boston Scientific Corporation; Medtronic; Philips Healthcare; Bard Peripheral Vascular, Inc.; 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): March 19, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 2019P000950

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• 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