Quality of life (QoL) nor the risk of amputation improve in patients with peripheral artery disease (PAD) who receive drug-coated stents or balloons versus uncoated devices, an analysis of the SWEDEPAD trials shows. These data were presented by Mårten Falkenberg, MD, of the University of Gothenburg, Sweden, on behalf of the SWEDEPAD 1 and 2 investigators, during Hot Line session on Sunday at the European Society of Cardiology (ESC) Congress in Madrid. “Drug-coated balloons and stents have been shown to reduce restenosis and the need for reinterventions in the endovascular treatment of PAD,” said Professor Joakim Nordanstig, MD, also from the University of Gothenburg, in an ESC news release on Sunday. “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.” The SWEDEPAD project included SWEDEPAD 1 and 2, which were multicenter, randomized trials. The investigators of the project were evaluating the effectiveness of the latest available methods for restenosis: drug-coated balloons and stents. SWEDEPAD 1 included 2,355 patients with chronic limb-threatening ischemia and patients were randomized to receive coated or uncoated balloons or stents. Amputation rate, the primary endpoint, did not significantly differ between-groups (hazard ratio [HR]=1.05, 95% confidence interval [CI]=0.87-1.27) across the 5-year follow-up. QoL and all-cause mortality were also the same between the coated and uncoated groups. SWEDEPAD 2 inlcuded 1,555 patients with Intermittent claudication and patients were randomized to coated or uncoated balloons or stents. The primary efficacy endpoint, QoL, was not significantly different between uncoated and coated patients at 1-year follow-up. Target vessel reintervention rates were also similar at 1-year, or the median follow-up of 6.2 years. Over 7.1 years, death rates did not differ significantly, but higher 5-year mortality was noted in the drug-coated devices group versus the uncoated devices group (HR=1.47, 95% CI=1.09-1.98). Overall, drug-coated balloons and stents did not improve QoL, 5-year outcomes nor amputation rates in patients with PAD compared with uncoated devices. "Given the signal of increased mortality with intermittent claudication, clinicians should carefully evaluate the potential risks and benefits when considering these expensive devices," Dr. Falkenberg concluded in the news release. Image Caption: Mårten Falkenberg, MD, discusses the SWEDEPAD 1 and 2 trials at the European Society of Cardiology (ESC) Congress 2025. Image Credit: Screenshot of European Society of Cardiology (ESC) Congress 2025 online by Bailey G. Salimes, CRTonline.org.