LEVANT I Supports the Lutonix Moxy Drug-Eluting Balloon to Treat PAD

September 23, 2010—Findings presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, DC, from the LEVANT I study yielded positive results for the use of drug-eluting balloons to treat peripheral arterial disease.

As reported by TCT Daily, Dierk Scheinert, MD, presented findings that showed that the Moxy drug-coated balloon catheter (Lutonix, Inc., Maple Grove, MN) outperformed standard percutaneous transluminal angioplasty for the treatment of femoropopliteal disease. Dr. Scheinert stated, “The primary endpoints of late lumen loss in the intention-to-treat and per protocol analyses at 6 months were met.”

The LEVANT I analysis involved 49 patients in the Moxy arm and 52 patients in the standard treatment arm. Moxy is a drug-eluting balloon coated with 2 µg/mm² paclitaxel with a hydrophilic nonpolymeric carrier.

In the intention-to-treat analysis, the Moxy balloon yielded a 0.46-mm late lumen loss compared with a 1.09-mm loss associated with standard intervention (P = .016). In the per protocol analysis, the Moxy balloon yielded a 0.36-mm loss, and standard intervention led to a 1.08-mm loss (P = .016).

For the secondary endpoint of target lesion revascularization, intention-to-treat results indicated a 13% rate in the Moxy arm compared with 22% in the angioplasty arm. Per protocol analysis results indicated a 6% target lesion revascularization rate in the Moxy arm versus 21% for angioplasty.

Further analysis indicated that the Moxy group had a lower incidence of other secondary events, including target vessel revascularization, thrombosis, death, and composite clinical endpoints than standard treatment in both the intention-to-treat and per protocol analyses, reported TCT Daily.

“With a relatively short dual-antiplatelet regimen of 1 month in the group with no stent and 3 months in the stent group, there were no reported incidents of acute or late thrombosis in the Moxy group,” stated Dr. Scheinert.