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

Beth Israel Deaconess Medical Center168,553 enrolled

Overview

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.

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

168,553

Conditions

Peripheral Arterial Disease Paclitaxel Adverse Reaction Safety Issues

Eligibility

Sex: ALLMin age: 66 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

All-cause mortality

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

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