The LEVANT I (Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis) Trial for Femoropopliteal Revascularization: First-in-Human Randomized Trial of Low-Dose Drug-Coated Balloon Versus Uncoated Balloon Angioplasty

doi:10.1016/j.jcin.2013.05.022

JACC: Cardiovascular Interventions

Volume 7, Issue 1, January 2014, Pages 10-19

https://doi.org/10.1016/j.jcin.2013.05.022 Get rights and content

Under an Elsevier user license

open archive

Objectives

This study sought to evaluate the safety and efficacy of the Lutonix drug-coated balloon (DCB) coated with 2 μg/mm² paclitaxel and a polysorbate/sorbitol carrier for treatment of femoropopliteal lesions.

Background

Percutaneous treatment of peripheral vascular disease is associated with a high recurrence. Paclitaxel-coated balloons at 3 μg/mm² formulated differently have shown promising results with reduced restenosis.

Methods

Subjects at 9 centers with Rutherford class 2 to 5 femoropopliteal lesions were randomized between June 2009 and December 2009 to treatment with Lutonix DCB (n = 49) versus uncoated balloons (control group [n = 52]), 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.

Results

Demographic, peripheral vascular disease, and lesion characteristics were matched, with mean lesion length of 8.1 ± 3.8 cm and 42% total occlusions. 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 = 0.016). Composite 24-month major adverse events were 39% for the DCB group, including 15 target lesion revascularizations, 1 amputation, and 4 deaths versus 46% for uncoated balloon group, with 20 target lesion revascularizations, 1 thrombosis, and 5 deaths. Pharmacokinetics showed biexponential decay with peak concentration (C_max) of 59 ng/ml and total observed exposure (AUC_all) of 73 ng h/ml. For successful DCB deployment excluding 8 malfunctions, 6-month late lumen loss was 0.39 mm and the 24-month target lesion revascularization rate was 24%.

Conclusions

Treatment of femoropopliteal lesions with the low-dose Lutonix DCB reduced late lumen loss with safety comparable to that of control angioplasty. (LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis; NCT00930813)

Key Words

angioplasty

drug-coated balloon

drug-eluting balloon

paclitaxel

peripheral vascular disease

restenosis

Abbreviations and Acronyms

DCB

drug-coated balloon(s)

ITT

intention to treat

LLL

late lumen loss

pharmacokinetics

TLR

target lesion revascularization(s)

Cited by (0)

: This clinical trial was sponsored by Lutonix, Inc., a subsidiary of C. R. Bard. Dr. Scheinert serves on the scientific advisory board of Lutonix. Dr. Duda has received study honorarium from Lutonix; and formerly served on the LEVANT-I Steering Committee. Dr. Zeller serves on the advisory boards to Medtronic Invatec, Medtronic Ardian, W. L. Gore & Associates, Angioslide, and Covedian-ev3; has received consulting fees from C. R. Bard, Johnson & Johnson Cordis, Boston Scientific, Straub Medical, Invatec, and Biotronik; and has received research grants from Cook, Krauth Medical, Abbott Vascular, and InnoRa. Dr. Tepe consults for Abbott, Covidien, Medtronic, and Medrad. Dr. Naisbitt is an employee of Lutonix, a subsidiary of C. R. Bard. Dr. Rosenfield consults for Lutonix and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.