Drug-coated devices not associated with improved outcomes in patients with peripheral artery disease

Drug-coated stents and balloons were not associated with reduced risk of amputation or improved quality of life compared with uncoated devices in two trials in peripheral artery disease (PAD), according to late-breaking research presented in a Hot Line session today at ESC Congress 2025.

Explaining the rationale for the trials, Principal Co-Investigator, Professor Joakim Nordanstig from the University of Gothenburg, Sweden, said: "Drug-coated balloons and stents have been shown to reduce restenosis and the need for reinterventions in the endovascular treatment of PAD. 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 ischaemia and one in intermittent claudication - comparing drug-coated and uncoated devices."

SWEDEPAD 1 and 2 were pragmatic, participant-blinded, registry-based randomized trials conducted at 22 sites in Sweden.

In SWEDEPAD 1, 2,355 patients with chronic limb-threatening ischemia (Rutherford stage 4-6) undergoing infra-inguinal endovascular treatment were randomised 1:1 to drug-coated or uncoated balloons or stents. In nearly all of the drug-coated devices implanted, the drug delivered was paclitaxel (>99%). There was no significant difference in the primary endpoint of time to ipsilateral above-ankle amputation with drug-coated vs. uncoated devices (hazard ratio [HR] 1.05; 95% confidence interval [CI] 0.87 to 1.27) over 5 years of follow-up. Target vessel reinterventions were reduced in the drug-coated group during the first year (HR 0.81; 95% CI 0.66 to 0.98), but this difference disappeared with longer follow-up. There was no difference in all-cause mortality or in quality of life (as assessed using the VascuQoL-6 questionnaire).

In SWEDEPAD 2, 1,155 patients with intermittent claudication (Rutherford stage 1-3) undergoing infra-inguinal endovascular treatment were randomised 1:1 after successful guidewire crossing to receive either drug-coated or uncoated balloons or stents. All drug-coated devices implanted delivered paclitaxel. There was no difference in the primary efficacy endpoint of quality of life between the drug-coated and uncoated groups at 12 months (mean difference in VascuQoL-6 scores: -0.02; 95% CI -0.66 to 0.62). Target vessel reintervention rates were not different at 1 year or over a median follow-up of 6.2 years. All-cause mortality did not differ over 7.1 years (HR 1.18; 95% CI 0.94 to 1.48), although higher 5-year mortality was noted with drug-coated vs. uncoated devices (HR 1.47; 95% CI 1.09 to 1.98).

Summarizing the findings, Principal Co-Investigator, Professor Mårten Falkenberg from Sahlgrenska University Hospital and the University of Gothenburg, Sweden, said: "Paclitaxel-coated devices were not effective in preventing amputation in chronic limb-threatening ischemia or improving quality of life in intermittent claudication. 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."