Drug-coated stents and balloons were not associated with reduced risk of amputation or improved quality of life in patients with peripheral artery disease (PAD) compared with uncoated devices, according to results from the SWEDEPAD 1 and 2 trials presented at ESC Congress 2025.

In SWEDEPAD 1, researchers randomized 2,355 patients with chronic limb-threatening ischemia (Rutherford stage 4-6) undergoing infra-inguinal endovascular treatment to drug-coated or uncoated balloons are stents. In SWEDEPAD 2, approximately 1,200 patients with intermittent claudication (Rutherford stage 1–3) undergoing infra-inguinal endovascular treatment were randomized after successful guidewire crossing to either drug-coated or uncoated balloons or stents. Across both trials, nearly all drug-coated devices delivered paclitaxel.

SWEDEPAD 1 results, which were simultaneously published in The Lancet, found no significant difference between the drug-coated and uncoated cohorts in terms of the primary endpoint, which involved time to ipsilateral above-ankle amputation over five years of follow-up. While researchers noted that target vessel reinterventions were reduced in the drug-coated group during the first year, they said this difference disappeared with longer follow-up. No difference in all-cause mortality or in quality of life were observed.

In SWEDEPAD 2, also simultaneously published in The Lancet, study investigators found no difference in the primary efficacy endpoint of quality of life between the drug-coated and uncoated groups at 12 months. In other findings, target vessel reintervention rates were not different at one year or over a median follow-up of roughly six years. All-cause mortality did not differ over a 7-year period, although higher 5-year mortality was noted with drug-coated vs. uncoated devices, researchers said.

"Paclitaxel-coated devices were not effective in preventing amputation in chronic limb-threatening ischemia or improving quality of life in intermittent claudication," said Mårten Falkenberg, MD, principal co-investigator. "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."