Abstract

Multicenter, prospective single-arm IN.PACT Global Study from 2012 to 2014 There were 1406 patients with claudication (89%) or rest pain (11%) with complex femoropopliteal occlusive lesions who were treated with IN.PACT Admiral drug-coated balloon (DCB) angioplasty (Medtronic, Dublin, Ireland). Mean lesion length was 12 cm, and a third of the lesions were occluded. The Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization through 36 months was significantly lower in patients with chronic limb-threatening ischemia (68%) compared with claudicants (78%). Predictors of clinically driven target lesion revascularization through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, and chronic limb-threatening ischemia. DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease to treat complex lesions in a real-world population is associated with sustained clinical efficacy and low rates of reintervention at 3 years after the initial procedure.

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