Does Use of Drug-Coated Devices Improve Outcomes in Chronic Limb-Threatening Ischemia?

Lower extremity revascularization (LER) is a class I indication for chronic limb-threatening ischemia (CLTI), but the most effective LER approach has not been established. In this phase 3 trial, investigators randomized patients with CLTI to receive endovascular LER with one of three approaches: drug-coated balloon angioplasty with or without bare metal stent, drug-eluting stent placement, or plain balloon angioplasty with or without bare metal stent (ISRCTN14469736). The primary outcome was amputation-free survival.

The study included 480 participants in the U.K. (mean age, 72 years; 35% women; 26% current smokers). The majority of patients were receiving an anticoagulant or antiplatelet agent (87%) and medical therapy for hypercholesterole…