No patient benefit from drug-coated balloons in major Swedish trials
Drug-coated balloons and stents don’t reduce the risk of amputation or improve quality of life for people with peripheral artery disease in the legs. That’s the takeaway from two major clinical trials led by researchers at the University of Gothenburg.
Each year, the U.S. performs hundreds of thousands of angioplasty procedures, highlighting how common such interventions are worldwide.
Drug-coated devices cost significantly more than their uncoated counterparts and have long been touted as a promising option to help leg arteries stay open longer. But the new results, published in The Lancet, show that those expectations never materialized.
No difference
Mårten Falkenberg, adjunct professor at the Sahlgrenska Academy at the University of Gothenburg and senior consultant at Sahlgrenska University Hospital, says:
“We had hoped that these technically advanced products would lower the risk of amputation in very sick patients. When there is no difference compared to uncoated balloons and stents, we have to question whether they truly belong in standard care.”
For patients with intermittent claudication, there was no improvement in quality of life.
Joakim Nordanstig, adjunct professor at the Sahlgrenska Academy and senior consultant at Sahlgrenska University Hospital, adds:
“Our data suggest that any possible benefit must be weighed against risks for each individual. In one of the studies, we even observed a higher five-year mortality in the group that was treated with drug-coated devices.”
Two parallel studies
The devices tested are coated with paclitaxel, a cell division-inhibiting agent meant to prevent arteries from closing again. In Sweden, more than 3,500 patients across 22 hospitals were randomized to receive either coated or uncoated devices. The trials aimed to see if amputations could be avoided among those with chronic limb-threatening ischemia and if disease-specific quality of life could be improved for those with less severe disease.
These findings raise serious questions about the future use of such medical devices. They highlight the need to judge new technologies by clear clinical outcomes, patient experiences, and long-term safety—not just technical measures.
Articles:
- Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in chronic limb-threatening ischaemia (SWEDEPAD 1): a multicentre, participantmasked, registry-based, randomised controlled trial. DOI: https://doi.org/10.1016/S0140-6736(25)01585-5
- Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in patients with intermittent claudication (SWEDEPAD 2): a multicentre, participantmasked, registry-based, randomised controlled trial. DOI: https://doi.org/10.1016/S0140-6736(25)01584-3
SWEDEPAD refers to two extensive Swedish trials conducted over nearly a decade on the effects of drug-coated balloons and stents in peripheral artery disease. SWEDEPAD 1 focused on patients at risk of amputation, while SWEDEPAD 2 involved those with intermittent claudication.
The trials were spearheaded by the University of Gothenburg, with Uppsala Clinical Research Center (UCR) at Uppsala University managing data collection and registry operations.
Almost all (22 out of 28) Swedish vascular centers reporting to the national Swedvasc registry took part.
Funding sources included the Swedish Research Council, the Swedish Heart-Lung Foundation, Region Västra Götaland, and others.