Drug-coated Devices Not Associated With Improved Outcomes In Patients With Peripheral Artery Disease

Drug-coated stents and balloons were not associated pinch reduced consequence of amputation aliases improved value of life compared pinch uncoated devices successful 2 tests successful peripheral artery illness (PAD), according to late-breaking investigation presented successful a Hot Line convention coming astatine ESC Congress 2025.

Explaining nan rationale for nan trials, Principal Co-Investigator, Professor Joakim Nordanstig from nan University of Gothenburg, Sweden, said: "Drug-coated balloons and stents person been shown to trim restenosis and nan request for reinterventions successful nan endovascular curen of PAD. However, location are uncertainties regarding whether drug-coated devices amended outcomes that are meaningful to patients, value of life and reducing amputations, and location are immoderate concerns complete safety. We investigated these and different endpoints successful 2 tests successful PAD - 1 successful chronic limb-threatening ischaemia and 1 successful intermittent claudication - comparing drug-coated and uncoated devices."

SWEDEPAD 1 and 2 were pragmatic, participant-blinded, registry-based randomized tests conducted astatine 22 sites successful Sweden.

In SWEDEPAD 1, 2,355 patients pinch chronic limb-threatening ischemia (Rutherford shape 4-6) undergoing infra-inguinal endovascular curen were randomised 1:1 to drug-coated aliases uncoated balloons aliases stents. In astir each of nan drug-coated devices implanted, nan supplier delivered was paclitaxel (>99%). There was nary important quality successful nan superior endpoint of clip to ipsilateral above-ankle amputation pinch drug-coated vs. uncoated devices (hazard ratio [HR] 1.05; 95% assurance interval [CI] 0.87 to 1.27) complete 5 years of follow-up. Target alloy reinterventions were reduced successful nan drug-coated group during nan first twelvemonth (HR 0.81; 95% CI 0.66 to 0.98), but this quality vanished pinch longer follow-up. There was nary quality successful all-cause mortality aliases successful value of life (as assessed utilizing nan VascuQoL-6 questionnaire).

In SWEDEPAD 2, 1,155 patients pinch intermittent claudication (Rutherford shape 1-3) undergoing infra-inguinal endovascular curen were randomised 1:1 aft successful guidewire crossing to person either drug-coated aliases uncoated balloons aliases stents. All drug-coated devices implanted delivered paclitaxel. There was nary quality successful nan superior efficacy endpoint of value of life betwixt nan drug-coated and uncoated groups astatine 12 months (mean quality successful VascuQoL-6 scores: -0.02; 95% CI -0.66 to 0.62). Target alloy reintervention rates were not different astatine 1 twelvemonth aliases complete a median follow-up of 6.2 years. All-cause mortality did not disagree complete 7.1 years (HR 1.18; 95% CI 0.94 to 1.48), though higher 5-year mortality was noted pinch drug-coated vs. uncoated devices (HR 1.47; 95% CI 1.09 to 1.98).

Summarizing nan findings, Principal Co-Investigator, Professor Mårten Falkenberg from Sahlgrenska University Hospital and nan University of Gothenburg, Sweden, said: "Paclitaxel-coated devices were not effective successful preventing amputation successful chronic limb-threatening ischemia aliases improving value of life successful intermittent claudication. Given nan awesome of accrued mortality pinch intermittent claudication, clinicians should cautiously measure nan imaginable risks and benefits erstwhile considering these costly devices. Devices incorporating antiproliferative agents different than paclitaxel warrant further investigation successful PAD."