Researchers have found no statistically significant difference in mortality between patients treated with drug-coated devices and non-drug-coated devices in the SAFE-PAD study. Eric Secemsky, MD, an interventional cardiologist at Beth Israel Deaconess Medical Center (BIDMC) in Boston, reported this conclusion at the American College of Cardiology’s 70th Annual Scientific Session (ACC.21), held from May 15–17 virtually. The results were published simultaneously in JAMA Internal Medicine.
At the behest of the Food and Drug Administration (FDA), Secemsky and Robert Yeh, MD, also an interventional cardiologist at BIDMC, designed the SAFE-PAD (Safety assessment of femoropopliteal endovascular treatment with paclitaxel-coated devices) study to provide information on the safety of paclitaxel-coated devices.
Using claims data from the Centers for Medicare & Medicaid Services (CMS), the researchers evaluated survival following treatment with paclitaxel-coated devices in more than 160,000 leg artery revascularization procedures conducted between 2015 and 2018.
“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 Secemsky. “Although the 2018 findings [reported by Konstantinos Katsanos, MD, et al] 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.”
Secemsky and colleagues’ study included Medicare patients treated with either a drug-coated or non-drug coated peripheral device between 2015 and 2018 at nearly 3,000 hospitals across the U.S. Deaths were evaluated through May 2020, and after accounting for any differences in demographics and comorbidities between the two groups, the investigators found no evidence that drug-coated devices were associated with higher mortality rates through an average 2.7 years of follow-up, with some patients having follow-up through five years.
“We used a number of novel statistical methods to assure these results were accurate, and found consistent results across a number of different patient groups—including among those of lower overall risk, those with more severe disease, and those treated in outpatient centers,” Secemsky said. “We have provided these results to the FDA to make decisions on whether to continue to restrict these drug-coated devices to only those at high risk of needing another leg procedure, or to return to the previous indications where these were used without restriction.”
The current publication is the first report of seven planned biannual reports as part of the SAFE-PAD study, which was designed to continue until all patients in the study had follow-up exceeding five years. As such, Secemsky and colleagues will continue to analyze these Medicare beneficiaries and update their findings until this study completes in late 2023.
“The SAFE-PAD study is a model example for collaboration between industry, academia and the FDA to carry out rigorously designed, real-world studies to evaluate important medical device safety signals,” said Yeh. “We believe that applying stringent scientific standards to observational studies can create greater confidence in validity of these ‘big data’ approaches to the evaluation of medical therapies.”
