WASHINGTON – Aan investigational paclitaxel-coated balloon catheter resulted in significant reductions in late lumen loss at 6 months compared with standard balloon angioplasty in a randomized study of 101 patients with femoropopliteal disease.
Tthe LEVANT I study randomized1patients to angioplasty – with or without stenting – using a regular angioplasty balloon catheter or the Moxy (Lutonix) paclitaxel-coated balloon catheter.
Six-month late lumen loss, the primary end point, was 0.46 mm in the paclitaxel-coated balloon group and 1.09 in the traditional angioplasty group, a statistically significant difference, reported Dr. Dierk Scheinert of the Heart Center Leipzig/Park Hospital, Germany.
Late lumen loss was reduced with the paclitaxel-coated balloon catheter in both the stented and nonstented patients. There also was a trend toward lower target lesion revascularization among patients who received treatment with the Moxy balloon catheter.
The paclitaxel-coated balloon catheter appears to have a “strong biologic effect … on the inhibition of neointimal hyperplasia,” Dr. Scheinert said at the meeting, sponsored by the Cardiovascular Research Foundation.
The study suggests that a shorter duration of antiplatelet therapy is feasible in the peripheral vasculature when such treatment is employed, he noted. Patients who were not stented were prescribed 1 month of a dual-antiplatelet regimen. Those who were stented were prescribed 3 months of the regimen.
The Moxy device is designed so that paclitaxel is retained during transit of the balloon catheter and is delivered during the 30- to 60-second inflation time. A larger and longer prospective randomized trial to look at primary patency of the target lesion and various clinical end points – LEVANT II – was pending approval, Dr. Scheinert said.
The trial was sponsored by Lutonix Inc., maker of the Moxy catheter. Dr. Scheinert had no disclosures.