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Longitudinal assessment of safety of femoropopliteal endovascular treatment with paclitaxel- coated devices: The SAFE-PAD Study

JAMA May 28, 2021

Secemsky EA, Shen C, Schermerhorn M, et al. - This study sought to provide a longitudinal evaluation of the safety of femoropopliteal endovascular treatment with peripheral drug-coated devices (DCDs) among Medicare beneficiaries. Between April 1, 2015, and December 31, 2018, researchers conducted SAFE-PAD study (Safety Assessment of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices) that was a retrospective cohort study designed with the US Food and Drug Administration to assess the noninferiority of mortality between DCDs and non–drug-coated devices (NDCDs) for femoropopliteal revascularization performed in 2978 inpatient and outpatient facilities in the US. In this study, 70 584 (41.9%) were treated with a DCD out of 168,553 patients. DCDs were found to be non-inferior to NCDCs in respect to mortality through a median follow-up of 2.72 years in this initial report from the SAFE-PAD cohort study. This observation remained robust in sensitivity analyses and was consistent across prespecified subgroups.

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