Treating patients with peripheral artery disease using drug-coated balloons proved superior to standard balloons for efficacy, at least one year out, in the LEVANT 2 randomized trial. Both approaches provided similar safety profiles.

The results were published online June 24 in the New England Journal of Medicine.  

LEVANT 2 (Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis) is the pivotal trial that informed the FDA’s decision in October 2014 to approve Bard’s Lutonix drug-coated balloon for use in the superficial femoral artery and the popliteal artery. Bard funded the study.

In the trial, 316 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions received angioplasty with the Lutonix drug-coated balloon. The control group consisted of 160 patients who were treated with standard balloons.

The primary effectiveness endpoint was patency of the target lesion at 12 months and the primary safety endpoint was the composite of freedom from perioperative death from any cause at 30 days after the procedure and freedom for amputation and revascularization of the target lesion and limb-related death at 12 months.

At 12 months, the rate of primary patency was 65.2 percent with drug-coated balloons and 52.6 percent with standard balloons. In addition, 83.9 percent of patients in the drug-coated balloon group and 79 percent in the standard balloon group met the composite safety endpoint. Event-free survival was similar for both groups.

The trial differed from some previous studies, not only in size but also exclusion criteria, according to the researchers. For instance, before randomization patients underwent a second angiography procedure to identify those who likely would require stenting. This may have eliminated some confounding and it also may explain the low revascularization rates; the freedom of target lesion revascularization rates were 89.7 percent with the drug-coated balloon and 84.7 percent with standard balloons.

Other smaller trials, including LEVANT 1, also used angiographic late lumen loss as a surrogate for patency. “The difference in the rate of binary restenosis in our trial, which was based on blinded analysis at a core laboratory, suggests a significant biologic effect of the use of the drug-coated balloon,” they wrote.

For more information on interventions for patients with peripheral artery disease, read “Direct Deposit: PAD Stents & Balloons Deliver Drugs Where They Count.”