Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease

Study Questions:

What is the efficacy and safety of the paclitaxel-coated balloon in comparison to standard percutaneous transluminal angioplasty (PTA) catheter for treatment of femoropopliteal arteries?


LEVANT 2 was a single-blind randomized trial conducted at 54 sites. The investigators assigned, in a 2:1 ratio, 476 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to standard angioplasty. The primary efficacy endpoint was primary patency of the target lesion at 12 months (defined as freedom from binary restenosis or from the need for target lesion revascularization). The primary safety endpoint was a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death (i.e., death from a medical complication related to a limb), amputation, and reintervention.


The two groups were well matched at baseline; 42.9% of the patients had diabetes, and 34.7% were current smokers. At 12 months, the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty (65.2% vs. 52.6%, p = 0.02). The proportion of patients 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 death, amputation, thrombosis, or reintervention.


The authors concluded that PTA with a paclitaxel-coated balloon resulted in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a standard balloon.


This study reports that the drug-coated angioplasty balloon resulted in a significantly greater rate of primary patency of the target lesion at 12 months than that achieved with a standard angioplasty balloon. In addition, the safety of the drug-coated balloon, as assessed by a composite endpoint of freedom from perioperative death from any cause and freedom at 1 year from index-limb amputation, index-limb revascularization, and index-limb–related death, was noninferior to that of the standard balloon. Long-term follow-up data are needed to determine whether the benefits of a drug-coated balloon are sustained, increased, or attenuated over time. Additional studies are indicated to compare the drug-coated balloon with other therapeutic options, such as atherectomy or stenting with bare-metal or drug-eluting stents.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Interventions and Vascular Medicine

Keywords: Amputation, Angioplasty, Angioplasty, Balloon, Atherectomy, Drug-Eluting Stents, Intermittent Claudication, Peripheral Arterial Disease, Stents, Thrombosis

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