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JACC Cardiovasc Interv. 2014 Jan;7(1):10-9. doi: 10.1016/j.jcin.2013.05.022.

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.

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Center of Vascular Medicine, Heart Center Leipzig/Park Hospital, Leipzig, Germany. Electronic address:
Center for Diagnostic Radiology and Minimally Invasive Therapy, Jewish Hospital, Berlin, Germany.
Department of Interventional Angiology, Herz-Zentrum, Bad Krozingen, Germany.
Cardiovascular Center, Hamburg University Cardiovascular Center, Hamburg, Germany.
Clinic for Radiology and Nuclear Medicine, University of Magdeburg, Magdeburg, Germany.
Flanders Medical Research Program, Department of Vascular Surgery, St. Blasius Hospital, Dendermonde, Belgium.
Department of Diagnostic and Interventional Radiology, RoMed Academic Hospital of Rosenheim, Rosenheim, Germany.
Lutonix, Inc., New Hope, Minnesota.
Department of Medicine-Cardiology, Massachusetts General Hospital, Cambridge, Massachusetts.



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


Percutaneous treatment of peripheral vascular disease is associated with a high recurrence. Paclitaxel-coated balloons at 3 μg/mm(2) 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.


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 (Cmax) 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%.


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)


DCB; ITT; LLL; PK; TLR; angioplasty; drug-coated balloon; drug-coated balloon(s); drug-eluting balloon; intention to treat; late lumen loss; paclitaxel; peripheral vascular disease; pharmacokinetics; restenosis; target lesion revascularization(s)

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