Author + information
- Received September 16, 2012
- Revision received March 18, 2013
- Accepted May 9, 2013
- Published online January 1, 2014.
- Dierk Scheinert, MD∗∗ (, )
- Stephan Duda, MD†,
- Thomas Zeller, MD‡,
- Hans Krankenberg, MD§,
- Jens Ricke, MD‖,
- Marc Bosiers, MD¶,
- Gunnar Tepe, MD#,
- Scott Naisbitt, MD, PhD∗∗ and
- Kenneth Rosenfield, MD††
- ∗Center of Vascular Medicine, Heart Center Leipzig/Park Hospital, Leipzig, Germany
- †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
- ↵∗Reprint requests and correspondence:
Dr. Dierk Scheinert, Center for Vascular Medicine-Angiology, Cardiology and Vascular Surgery, Park Hospital Leipzig, Strümpellstrasse 41, 04289 Leipzig, Germany.
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 (Cmax) of 59 ng/ml and total observed exposure (AUCall) 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)
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.
- Received September 16, 2012.
- Revision received March 18, 2013.
- Accepted May 9, 2013.
- American College of Cardiology Foundation