Study Finds No Clinical Benefit of Drug-Coated Devices in Peripheral Artery Disease
Large clinical trials reveal that drug-coated stents and balloons do not improve outcomes or reduce amputations in patients with peripheral artery disease, prompting a reevaluation of their use.
Recent research presented at ESC Congress 2025 indicates that the use of drug-coated stents and balloons does not lead to improved outcomes for patients with peripheral artery disease (PAD). In two large-scale trials, neither device type was associated with a reduced risk of limb amputation nor a significant enhancement in quality of life compared to uncoated devices.
The trials, SWEDEPAD 1 and 2, involved patients at different stages of PAD: chronic limb-threatening ischemia and intermittent claudication, respectively. Both studies were designed as pragmatic, participant-blinded, registry-based randomized trials across 22 sites in Sweden.
In SWEDEPAD 1, which included 2,355 patients with severe ischemia undergoing infra-inguinal endovascular treatment, nearly all drug-coated devices used contained paclitaxel. Over five years, there was no significant difference in the primary outcome—time to ipsilateral above-ankle amputation—between the drug-coated and uncoated groups. While initial findings showed a reduction in target vessel reinterventions within the first year for the drug-coated group, this benefit was not sustained long-term. Importantly, there were no differences in overall mortality or quality of life measures.
Similarly, the SWEDEPAD 2 trial with 1,155 patients suffering from intermittent claudication also found no significant improvements in quality of life or reintervention rates between the two groups over a median follow-up of over six years. Notably, higher five-year mortality rates were observed in patients treated with drug-coated devices.
Lead researcher Professor Mårten Falkenberg emphasized caution, noting that paclitaxel-coated devices did not prevent limb amputation or improve life quality, and raised concerns about potential increased mortality risks. He recommended that clinicians carefully evaluate the risks and benefits when considering these devices, and highlighted the need for further research into alternative antiproliferative agents.
This compelling evidence challenges previous assumptions about the efficacy of drug-coated devices in PAD treatment, urging the medical community to reassess their use in clinical practice.
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