Rationale and Design of the SAFE-PAD Study.

ABSTRACT:

Background

Recent evidence from randomized controlled trials has raised concerns about the long-term safety of paclitaxel-coated peripheral devices used for femoropopliteal artery revascularization. In response to a call for more real-world data on the safety of these devices, the SAFE-PAD study (Safety Assessment of Femoropopliteal Endovascular treatment with Paclitaxel-coated Devices) was designed with input from the Food and Drug Administration to provide a long-term, comprehensive evaluation of the mortality risk associated with paclitaxel-coated devices among Medicare beneficiaries.

Methods and results

SAFE-PAD is an observational cohort study of fee-for-service Medicare beneficiaries that underwent femoropopliteal artery revascularization with either a drug-coated devi

SUBMITTER: Secemsky EA 

PROVIDER: S-EPMC7886015 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature