Drug-coated devices as good as NCDCs for endovascular treatment of PAD: JAMA study

Paclitaxel-coated peripheral devices have been linked with increased mortality, yet this harm signal has not been replicated outside of meta-analyses of small trials.

A group of researchers from Boston, Massachusetts, U.S.A. conducted a study to provide a longitudinal assessment of the safety of femoropopliteal endovascular treatment with peripheral drug-coated devices (DCDs) among Medicare beneficiaries.

The researchers designed a retrospective cohort study named SAFE-PAD (Safety Assessment of Femoropopliteal Endovascular Treatment with Paclitaxel-Coated Devices) in association with the US Food and Drug Administration to evaluate the noninferiority of mortality between DCDs and non–drug-coated devices (NDCDs) for femoropopliteal revascularization performed in 2978 inpatient and outpatient facilities in the U.S.A from April 1, 2015, through December 31, 2018.

Participants were Medicare fee-for-service beneficiaries 66 years and older with 1 or more years of enrolment prior to femoropopliteal revascularization. Of 168 553 patients, 70 584 were treated with a DCD. The Median follow-up was 2.72 years.

Sensitivity analyses were used to evaluate the potential influence of unmeasured confounding.

The results of the study are as follows:

• After weighting, the cumulative incidence of all-cause mortality was 53.8% with DCDs and 55.1% with NDCDs.
• Cox regression and instrumental variable analyses were consistent with the primary findings.
• No harm associated with DCDs was observed among subgroups, including those treated with stents or balloons, with or without CLI; and those within the lowest quartile of total comorbidities.

The researchers concluded that through this initial report from the SAFE-PAD cohort study, Drug-coated devices (DCDs) were found to be non-inferior to Non- drug-coated devices (NCDCs) in respect to mortality through a median follow-up of 2.72 years. This finding remained robust in sensitivity analyses and was consistent across prespecified subgroups.

Reference:

Longitudinal Assessment of Safety of Femoropopliteal Endovascular Treatment with Paclitaxel-Coated Devices Among Medicare Beneficiaries: The SAFE-PAD Study by Secemsky, E et. al published in the JAMA Intern Med.

doi:10.1001/jamainternmed.2021.2738