Drug-coated devices were noninferior to non-drug-coated devices for all-cause mortality in Medicare beneficiaries who had femoropopliteal revascularization, according to an initial report from the SAFE-PAD study presented May 16 in a Featured Clinical Research session during ACC.21 and simultaneously published in JAMA Internal Medicine.

Eric A. Secemsky, MD, MSc, FACC, et al., designed this retrospective cohort study with feedback from the U.S. Food and Drug Administration (FDA) to provide a longitudinal assessment of the safety of the drug-coated devices in this setting because of data from meta-analyses of small trials showing an association between drug-coated devices and increased mortality. 

Among 168,553 Medicare fee-for-service beneficiaries (45% women, 82% white, mean age 77 years) who underwent femoropopliteal artery revascularization from 2015 through 2018, 51% had diabetes, 49% used tobacco, 46% had critical limb ischemia (CLI), and 8% had a previous amputation. A drug-coated device was used in 41.9%.

Results showed that after weighting, cumulative all-cause mortality over the median 2.72 years of follow-up (longest, 5.16 years) was 53.8% with drug-coated devices and 55.1% with non-drug-coated devices (hazard ratio, 0.95; 95% confidence interval, 0.94-0.97; noninferiority p<0.001). Sensitivity analyses were consistent and robust for the primary outcome.

This finding with drug-coated devices was consistent across prespecified subgroups, including treatment with stents or balloons, presence or absence of CLI, and the lowest quartile of total morbidities.

"SAFE-PAD will continue until the median follow-up of all patients surpasses 5 years and will provide the FDA a mechanism for the ongoing safety evaluation of these devices," write the authors. "Furthermore, SAFE-PAD may serve as a case example of how to leverage real-world evidence to provide timely device safety evaluations."

In a related editorial comment, Rita F. Redberg, MD, MSc, FACC, and Mary M. McDermott, MD, write "this analysis did not confirm the signal of harm seen in the [randomized clinical trials]." However, they explain that it raises "new and important questions" about the high rates of mortality in this population undergoing endovascular revascularization, and note that more than half of patients with [peripheral artery disease (PAD)] died during the 2.7 years of follow-up. Furthermore, patients with PAD have higher rates of death from cardiovascular events, and "recent evidence shows a high rate of death from cancer and infection" in PAD. Thus, there should be a continued focus on conservative treatment, including smoking cessation and exercise therapy to improve quality of life, they conclude.

Clinical Topics: Vascular Medicine

Keywords: ACC Annual Scientific Session, ACC21, Aneurysm, Paclitaxel, Femoral Artery

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