Published 6-Month LEVANT I Data Support Bard's Lutonix DCB

January 20, 2014—Professor Dierk Scheinert, MD, et al published 6-month data from the LEVANT I study in the Journal of the American College of Cardiology: Cardiovascular Interventions (2014;7:10–19). LEVANT I sought to evaluate the safety and efficacy of the Lutonix drug-coated balloon (DCB) (Bard Peripheral Vascular, Inc., Tempe, AZ). 

The LEVANT I investigators concluded that treatment of femoropopliteal lesions with the low-dose Lutonix DCB reduced late lumen loss with safety comparable to that of control angioplasty. The Lutonix DCB is coated with 2 μg/mm² paclitaxel and a polysorbate/sorbitol carrier for treating femoropopliteal lesions.

According to the investigators, the background of the study is that percutaneous treatment of peripheral vascular disease is associated with a high recurrence. Paclitaxel-coated balloons at 3 μg/mm² are formulated differently and have shown promising results with reduced restenosis.

As summarized in Journal of the American College of Cardiology: Cardiovascular Interventions, the LEVANT I study was conducted at nine centers between June 2009 and December 2009. Patients with Rutherford class 2 to 5 femoropopliteal lesions were randomized to treatment with the Lutonix DCB (n = 49) versus uncoated balloons (n = 52) and stratified by whether balloon-only treatment (n = 75) or stenting (n = 26) was intended. The primary endpoint was angiographic late lumen loss at 6 months. Secondary outcomes included adjudicated major adverse events (death, amputation, target lesion thrombosis, reintervention), functional outcomes, and pharmacokinetics.

Demographic, peripheral vascular disease, and lesion characteristics were matched, with a mean lesion length of 8.1 ± 3.8 cm and 42% total occlusions. The investigators found that at 6 months, late lumen loss was 58% lower for the Lutonix DCB group (0.46 ± 1.13 mm) than for the control group (1.09 ± 1.07 mm; P = .016). Composite 24-month major adverse events were 39% for the DCB group, including 15 target lesion revascularizations, one amputation, and four deaths, versus 46% for uncoated balloon group, with 20 target lesion revascularizations, one thrombosis, and five deaths. 

Pharmacokinetics showed biexponential decay with peak concentration (Cmax) of 59 ng/mL and total observed exposure (AUCall) of 73 ng h/mL. For successful DCB deployment, excluding eight malfunctions, 6-month late lumen loss was 0.39 mm, and the 24-month target lesion revascularization rate was 24%, reported the investigators.

Prof. Scheinert first presented 6-month LEVANT I data in September 2010 at the TCT 2010: Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC. At that time, the device was known as the Moxy DCB, developed by Lutonix, Inc. (Maple Grove, MN). Bard acquired the company and device in December 2011 for approximately $225 million paid at closing. An additional $100 million is to be paid upon United States regulatory approval of the Lutonix DCB.

On November 25, 2013, Bard announced that it had submitted the final module of the premarket approval application to the US Food and Drug Administration to support approval for the Lutonix DCB. Bard’s pivotal LEVANT 2 study is being conducted to support this submission. In October, 6-month data from LEVANT 2 were presented by Kenneth Rosenfield, MD, at TCT 2013 in San Francisco, California. Dr. Rosenfield and Prof. Scheinert are coprimary investigators of the LEVANT 2 trial.