ILLUMENATE Trial design: Patients with superficial femoral artery (SFA) and/or popliteal arterial stenoses were randomized in a 2:1 fashion to either balloon.

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Presentation transcript:

ILLUMENATE Trial design: Patients with superficial femoral artery (SFA) and/or popliteal arterial stenoses were randomized in a 2:1 fashion to either balloon angioplasty with a paclitaxel drug-coated balloon (DCB) or standard balloon. They were followed for 12 months. Results (p < 0.05) Primary efficacy outcome, clinically driven target lesion revascularization: DCB vs. standard balloon: 93.6% vs. 87.3%, p < 0.05 Primary patency at 12 months: 82.3% vs. 70.9%, p < 0.05 % Conclusions Percutaneous transluminal angioplasty (PTA) with a novel low-dose paclitaxel-coated balloon was superior to PTA with standard angioplasty alone in moderately long lesions in the SFA and/or popliteal arteries Data were similar to the LEVANT 2 trial, which used a different balloon but the same drug (differences are in balloon design and dose of paclitaxel) Primary endpoint DCB (n = 200) Standard PTA (n = 100) Presented by Dr. Sean Lyden at TCT 2016