Drug-coated stents shown non-inferior for peripheral artery disease
An analysis of 168, 553 Medicare recipients who underwent femoropopliteal artery revascularization from 2015 through 2018 showed the weighted cumulative incidence of mortality at 5 years was 53.8% among those treated with drug-coated devices and 55.1% among those treated with non–drug-coated devices.
Paclitaxel-coated devices took a hit following an August 2019 FDA warning to healthcare providers to carefully consider whether to use them. The use of the devices first plunged after a meta-analysis published in the Journal of the American Heart Association in December 2018 suggested that PAD patients treated with paclitaxel-coated balloons and stents could be at a higher risk for late death.
At the FDA’s request, researchers from Beth Israel Deaconess Medical Center conducted this new study, dubbed SAFE-PAD (Safety Assessment of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices). They noted that the risk of late death had not been replicated outside of meta-analyses of small trials. SAFE-PAD will be an ongoing study to continue evaluating the safety of these devices.
Current study results came from 2,978 inpatient and outpatient facilities in the U.S. from April 1, 2015, through December 31, 2018. Evaluation of the primary outcome was assessed through May 31, 2020. Participants were Medicare fee-for-service beneficiaries 66 years and older.
Of 168 553 patients, 70,584 (41.9%) were treated with a drug-coated device. The mean age was 77 years, and 44.9% were female. Nearly 82% were white, 51% had diabetes, 49% used tobacco, 45.7% had critical limb ischemia and 7.9% had a prior amputation. The median follow-up was 2.72 years.
After weighting, the cumulative incidence of all-cause mortality was 53.8% with drug-coated devices and 55.1% with nondrug-coated devices. Researchers observed no harm associated with drug-coated devices, including those treated with stents or balloons, with or without critical limb ischemia.
“Our study of Medicare beneficiaries includes more than 160,000 patients, including more than 30,000 patients with survival data extending past four years, making it one of the largest and most comprehensive evaluations of the safety of drug-coated devices to be published since the initial analysis,” said researcher and cardiologist Eric Secemsky, director of vascular intervention at Beth Israel Deaconess, in a
“Although the 2018 findings raised concerns about the safety of these drug-coated devices, there were many issues with that analysis — including the study’s small size and a lack of complete patient follow-up.”