New study provides ‘substantial evidence’ paclitaxel-coated devices are safe when treating lower-limb PAD
Treating peripheral artery disease (PAD) in the lower limbs with a paclitaxel-coated device (PCD) is safe, according to new research published in the Journal of the American College of Cardiology.[1] In fact, treatment with a PCD was associated with improved survival compared to treatment without such a device.
“The efficacy of drug-eluting devices has been shown by various studies,” wrote first author Matthieu Wargny, PhD, a healthcare researcher with CHU de Nantes in France, and colleagues. “However, in December 2018, a meta-analysis suggested increased all-cause mortality at two and five years with PCDs compared with noncoated devices used in the femoropopliteal segment. Since 2018, many investigations have been carried out to better evaluate these unexpected results.”
To learn more about this topic, Wargny and colleagues tracked data from nearly 260,000 patients who underwent endovascular revascularization for lower-limb PAD from 2011 to 2019. More than 20,000 of those patients—7.7% of the total patient population—were treated with at least one PCD.
Overall, after a median follow-up period of 4.1 years, 5,385 patients from the PCD group and 109,844 patients from the control group had died. This translated to 7.3 deaths per 100 person-years for the PCD group and 10.4 deaths per 100 person-years for the control group.
A series of multivariable analyses confirmed that PCDs were associated with a lower risk of mortality than the control group. In addition, even when removing all patients who died in the first 30 days after treatment, PCDs were still linked to a lower mortality risk.
“This study presents substantial evidence that the use of PCD is safe for the endovascular revascularization of lower limb artery disease,” the authors wrote. “By comparison, other real-world data analyses may have suffered from sample selection biases.”
Additional research is still needed, they added, to help identify which patients would benefit the most from treatment with a paclitaxel-coated balloon or stent.
Click here for the full study.
Findings support FDA’s 2023 ruling to lift restrictions
In 2023, the U.S. Food and Drug Administration (FDA) updated its stance on using PCDs to treat PAD, reversing restrictions originally put in place back in 2019.
“Based on the FDA's review of the totality of the available data and analyses, we have determined that the data does not support an excess mortality risk for paclitaxel-coated devices,” the agency said at the time.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.