Clinical trial NCT04496544: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Paclitaxel Adverse Reaction
Safety Issues
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Philips Healthcare
name: Bard Peripheral Vascular, Inc.
name: Boston Scientific Corporation
name: Cook Medical
First posted: 2020-08-03
Enrollment: 168553
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: All-cause mortality
timeFrame: 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:
measure: Repeat hospitalization
timeFrame: 1, 2 and 3 years after index procedure
measure: Repeat endovascular or surgical revascularization
timeFrame: 1, 2 and 3 years after index procedure
measure: Target vessel revascularization
timeFrame: 1, 2 and 3 years after index procedure
measure: Lower extremity amputation
timeFrame: 1, 2 and 3 years after index procedure
measure: Optimal medical therapy
timeFrame: 1, 2 and 3 years after index procedure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Eric A Secemsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: Robert W Yeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.