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Safety assessment of femoropopliteal endovascular treatment with paclitaxel-coated devices

JAMA Internal Medicine Aug 05, 2021

Secemsky EA, Shen C, Schermerhorn M, et al. - The non-inferiority of peripheral drug-coated devices (DCDs) for mortality to non–drug-coated devices (NDCDs) was evident in a cohort analysis of 168,553 Medicare fee-for-service beneficiaries who had femoropopliteal artery revascularization.

  • This is an initial report from the SAFE-PAD cohort study (a retrospective cohort study).

  • A median follow-up of 2.72 years (interquartile range, 0.87-3.77; longest, 5.16 years) was performed.

  • At 5 years, the weighted cumulative incidence of mortality was 53.8% and 55.1% with DCDs and with NDCDs, respectively.

  • No harm related to DCDs was noted among subgroups.

  • The observed non-inferiority of DCDs for mortality remained robust in sensitivity analyses and was consistent across prespecified subgroups.

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