BACKGROUND: The treatment of @entity3657 with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis. Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery, potentially improving vessel patency by reducing restenosis. METHODS: In this single-blind, randomized trial conducted at 54 sites, we assigned, in a 2:1 ratio, 476 @entity1 with symptomatic @entity613 or @entity158 while at rest and angiographically significant @entity731 to angioplasty with a @entity1311 -coated balloon or to standard angioplasty. The primary efficacy end point was primary patency of the @entity75 at 12 months (defined as freedom from binary restenosis or from the need for @entity75 revascularization). The primary safety end point was a composite of freedom from perioperative @entity204 from any cause and freedom at 12 months from limb-related @entity204 (i.e., @entity204 from a medical complication related to a limb), amputation, and reintervention. RESULTS: The two groups were well matched at baseline; 42.9% of the @entity1 had @entity6 , and 34.7% were current smokers. At 12 months, the rate of primary patency among @entity1 who had undergone angioplasty with the drug-coated balloon was superior to that among @entity1 who had undergone conventional angioplasty (65.2% vs. 52.6%, P=0.02). The proportion of @entity1 free from primary safety events was 83.9% with the drug-coated balloon and 79.0% with standard angioplasty (P=0.005 for noninferiority). There were no significant between-group differences in functional outcomes or in the rates of @entity204 , amputation, @entity715 , or reintervention. CONCLUSIONS: Among @entity1 with symptomatic femoropopliteal @entity3657 , percutaneous transluminal angioplasty with a @entity1311 -coated balloon resulted in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a standard balloon. The drug-coated balloon was noninferior to the standard balloon with respect to safety. (Funded by Lutonix-Bard; LEVANT 2 ClinicalTrials.gov number, NCT01412541.).

Trial of a XXXX -Coated Balloon for Femoropopliteal Artery Disease.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity3657 :: ('MESH:D058729', 'Disease') :: ['peripheral artery disease'] @entity6 :: ('MESH:D003920', 'Disease') :: ['diabetes'] @entity75 :: ('MESH:D001927', 'Disease') :: ['target-lesion', 'target lesion'] @entity1311 :: ('MESH:D017239', 'Chemical') :: ['paclitaxel'] @entity613 :: ('MESH:D007383', 'Disease') :: ['intermittent claudication'] @entity158 :: ('MESH:D010146', 'Disease') :: ['ischemic pain'] @entity731 :: ('MESH:D050197', 'Disease') :: ['atherosclerotic lesions'] @entity204 :: ('MESH:D003643', 'Disease') :: ['death'] @entity715 :: ('MESH:D013927', 'Disease') :: ['thrombosis']
@entity1311 :: (MESH:D017239,Chemical) :: ['Paclitaxel']
