Drug-coated balloons make little impact on PAD outcomes
Drug-coated stents and balloons, particularly those treated with paclitaxel, do not appear to significantly improve outcomes for patients with peripheral artery disease (PAD).
That was the primary takeaway from two new trials presented at ESC Congress 2025, the annual meeting of the European Society of Cardiology.
“Drug-coated balloons and stents have been shown to reduce restenosis and the need for reinterventions in the endovascular treatment of PAD,” co-principal investigator Joakim Nordanstig, MD, PhD, a researcher with the University of Gothenburg in Sweden, said in a prepared statement. “However, there are uncertainties regarding whether drug-coated devices improve outcomes that are meaningful to patients, quality of life and reducing amputations, and there are some concerns over safety. We investigated these and other endpoints in two trials in PAD—one in chronic limb-threatening ischemia (CLTI) and one in intermittent claudication—comparing drug-coated and uncoated devices.”
The first of the two studies, SWEDEPAD 1, included data from more than 2,300 patients with CLTI. The group was randomized to either undergo infrainguinal endovascular treatment with a drug-coated or uncoated balloon. More than 99% of the coated devices used for this trial delivered paclitaxel to the patient.
Overall, after five years, the study’s primary endpoint of time to ipsilateral above-ankle amputation was not significantly different among patients treated with the drug-coated devices. Target valve reinterventions were reduced in the first year, the authors added, but the difference was no longer significant by the end of the study’s five years.
In SWEDEPAD 2, meanwhile, more than 1,100 patients with intermittent claudication undergoing infrainguinal endovascular treatment were randomized to a drug-coated balloon or non-drug-coated balloon. All of the coated devices for this trial delivered paclitaxel to the patient during treatment.
Overall, there was no difference in quality of life between these two groups after 12 months. There was also not a significant difference in terms of target vessel reintervention after a median follow-up period of 6.2 years or all-cause mortality after a median follow-up period of 7.1 years. Five-year mortality, on the other hand, was actually higher for the group treated with paclitaxel-coated devices.
“Paclitaxel-coated devices were not effective in preventing amputation in CLTI or improving quality of life in intermittent claudication,” co-principal investigator Professor Mårten Falkenberg, a researcher with Sahlgrenska University Hospital, said in the same statement. “Given the signal of increased mortality with intermittent claudication, clinicians should carefully evaluate the potential risks and benefits when considering these expensive devices. Devices incorporating antiproliferative agents other than paclitaxel warrant further investigation in PAD.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.