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Drug-coated stents and balloons weren’t related to decreased danger of amputation or improved high quality of life in contrast with uncoated units in two trials in peripheral artery illness (PAD), based on late-breaking analysis introduced in a Sizzling Line session at present at ESC Congress 2025.
Explaining the rationale for the trials, principal co-investigator, Professor Joakim Nordanstig from the College of Gothenburg, Sweden, stated, “Drug-coated balloons and stents have been proven to scale back restenosis and the necessity for reinterventions within the endovascular therapy of PAD. Nonetheless, there are uncertainties relating to whether or not drug-coated units enhance outcomes which can be significant to sufferers, high quality of life and decreasing amputations, and there are some considerations over security.
“We investigated these and other endpoints in two trials in PAD—one in chronic limb-threatening ischemia and one in intermittent claudication—comparing drug-coated and uncoated devices.”
SWEDEPAD 1 and a pair of had been pragmatic, participant-blinded, registry-based randomized trials performed at 22 websites in Sweden.
In SWEDEPAD 1, 2,355 sufferers with continual limb-threatening ischemia (Rutherford stage 4–6) present process infra-inguinal endovascular therapy had been randomized 1:1 to drug-coated or uncoated balloons or stents. In almost all the drug-coated units implanted, the drug delivered was paclitaxel (>99%). There was no important distinction within the major endpoint of time to ipsilateral above-ankle amputation with drug-coated vs. uncoated units (hazard ratio [HR] 1.05; 95% confidence interval [CI] 0.87 to 1.27) over 5 years of follow-up.
Goal vessel reinterventions had been decreased within the drug-coated group in the course of the first yr (HR 0.81; 95% CI 0.66 to 0.98), however this distinction disappeared with longer follow-up. There was no distinction in all-cause mortality or in high quality of life (as assessed utilizing the VascuQoL-6 questionnaire).
In SWEDEPAD 2, 1,155 sufferers with intermittent claudication (Rutherford stage 1–3) present process infra-inguinal endovascular therapy had been randomized 1:1 after profitable guidewire crossing to obtain both drug-coated or uncoated balloons or stents. All drug-coated units implanted delivered paclitaxel.
There was no distinction within the major efficacy endpoint of high quality of life between the drug-coated and uncoated teams at 12 months (imply distinction in VascuQoL-6 scores: –0.02; 95% CI –0.66 to 0.62). Goal vessel reintervention charges weren’t completely different at one yr or over a median follow-up of 6.2 years. All-cause mortality didn’t differ over 7.1 years (HR 1.18; 95% CI 0.94 to 1.48), though larger 5-year mortality was famous with drug-coated vs. uncoated units (HR 1.47; 95% CI 1.09 to 1.98).
Summarizing the findings, principal co-investigator, Professor Mårten Falkenberg from Sahlgrenska College Hospital and the College of Gothenburg, Sweden, stated, “Paclitaxel-coated units weren’t efficient in stopping amputation in continual limb-threatening ischemia or bettering high 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.”
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European Society of Cardiology
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Drug-coated units don’t enhance outcomes in sufferers with peripheral artery illness, examine finds (2025, September 1)
retrieved 1 September 2025
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