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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.

Author information

1
Center of Vascular Medicine, Heart Center Leipzig/Park Hospital, Leipzig, Germany. Electronic address: dierk.scheinert@gmx.de.
2
Center for Diagnostic Radiology and Minimally Invasive Therapy, Jewish Hospital, Berlin, Germany.
3
Department of Interventional Angiology, Herz-Zentrum, Bad Krozingen, Germany.
4
Cardiovascular Center, Hamburg University Cardiovascular Center, Hamburg, Germany.
5
Clinic for Radiology and Nuclear Medicine, University of Magdeburg, Magdeburg, Germany.
6
Flanders Medical Research Program, Department of Vascular Surgery, St. Blasius Hospital, Dendermonde, Belgium.
7
Department of Diagnostic and Interventional Radiology, RoMed Academic Hospital of Rosenheim, Rosenheim, Germany.
8
Lutonix, Inc., New Hope, Minnesota.
9
Department of Medicine-Cardiology, Massachusetts General Hospital, Cambridge, Massachusetts.

Abstract

OBJECTIVES:

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.

BACKGROUND:

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.

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 (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%.

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)

KEYWORDS:

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)

PMID:
24456716
DOI:
10.1016/j.jcin.2013.05.022
[Indexed for MEDLINE]
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