SWEDEPAD 1 and 2: Similar outcomes for drug-coated and uncoated devices in PAD

Drug-coated devices did not improve clinical outcomes in patients with peripheral artery disease (PAD) compared with non-coated devices. This result was consistent across disease severity subpopulations in the SWEDEPAD 1 and 2 trials.  

The SWEDEPAD 1 and 2 studies (NCT02051088) investigated the effectiveness of drug-coated balloons and stents among patients with PAD. SWEDEPAD 1 enrolled 2,355 participants with chronic limb-threatening ischaemia with the primary endpoint of major amputation. SWEDEPAD 2 included 1,136 participants with intermittent claudication, with disease-specific quality-of-life as the primary endpoint. Participants in both trials were randomised 1:1 to drug-coated devices or uncoated devices. Prof. Marten Falkenberg (University Hospital Gothenburg, Sweden) presented the findings [1].

After 5 years of follow-up in SWEDEPAD 1, there was no difference between the 2 study arms with respect to major amputations (HR 1.05; 95% CI 0.87-1.27; P=0.61). “The amputation rate per 100 person-years was 6.17 in the drug-coated group and 5.96 in the uncoated group,” noted Dr Falkenberg.

The follow-up duration of SWEDEPAD 2 was also 5 years. Again, there was no difference between the groups for the primary outcome. The mean difference for one-year VascuQoL-6 was 0.02 (95% CI -0.66 to +0.62; P=0.96).

“Paclitaxel-coated devices did not reduce the amputation rate in patients with chronic limb-threatening ischaemia or improve quality-of-life in patients with intermittent claudication,” Dr Falkenberg concluded.

1. Falkenberg M, et al. SWEDEPAD 1 and 2: Impact of drug-coated devices in patients with peripheral arterial disease. Hotline 6, ESC Congress 2025, 29 August – 1 September, Madrid, Spain.

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Posted on 7 November 2025