Background and Disease Burden
Chronic limb-threatening ischaemia (CLTI) is the most severe form of peripheral artery disease (PAD), characterized by critical reductions in limb perfusion, often manifested as rest pain, ulcers, or gangrene (Rutherford categories 4-6). CLTI affects millions globally and carries significant risks of limb loss and mortality. Infrainguinal endovascular revascularisation has emerged as a key therapeutic approach to restore blood flow and prevent amputations. Drug-coated devices, particularly paclitaxel-coated balloons and stents, were developed to reduce restenosis by inhibiting neointimal hyperplasia. While these devices are commonly used in coronary and peripheral interventions, their impact on hard clinical endpoints in CLTI, specifically above-ankle major amputation rates, remains uncertain. Previous meta-analyses and studies raised concerns about potential increased mortality associated with paclitaxel-coated devices, further complicating their clinical use. Thus, the SWEDEPAD 1 trial was designed to address the critical question of whether paclitaxel-coated devices improve limb salvage outcomes compared to uncoated devices in patients with advanced PAD undergoing infrainguinal endovascular treatment.
