Patient selection and study design
stenotic lesions, peripheral arterial disease, CLI, ischemic rest pain, gangrene
PERIPHERAL ARTERIAL DISEASE, LIMB ISCHEMIA, ULCERS, GANGRENE, COAGULOPATHY
This trial compared the clinical outcomes of primary stenting and POBA for the treatment of patients with CLI and BTK lesions. Between December 2012 and September 2016, patients with CLI and BTK lesions were enrolled in this prospective, multicenter, randomized trial. Patients were eligible if they had peripheral arterial disease with ischemic rest pain, wounds, such as ulcers or gangrene, that manifested as BTK lesions. More than half of included patients had wounds with a Rutherford classification (RC) of 4–6. If the wound site was related to a vascular origin according to the angiosome concept, patients were included regardless of the RC of their wound. Patients with acute limb ischemia, those with a life expectancy < 1 year, systemic coagulopathy, or intolerance to antiplatelet agents were excluded. Angiographic eligibility criteria included the presence of de novo stenotic lesions involving 50% of the lumen or occlusion of BTK arteries, and patients meeting these criteria were considered acceptable for endovascular therapy (2.0–4.5 mm in diameter, lesion length < 80 mm owing to the stent length).