LEVANT I: Drug-Coated Catheter Reduces Late Lumen Loss in Femoropopliteal Intervention

Reed Miller

September 28, 2010

September 28, 2010 (Washington, DC) — Results of the LEVANT I study, presented at TCT 2010, offer more evidence that the antirestenosis drugs that have been successful in the coronaries can also improve outcomes of peripheral interventions [1].

Dr Dierk Scheinert

Dr Dierk Scheinert (Heart Center Leipzig, Germany) presented the six-month results from the LEVANT I study, which randomized 101 patients with femoropopliteal disease to angioplasty, with or without stenting, with the Moxy (Lutonix, Maple Grove, MN) paclitaxel-coated balloon catheter (n=49) or to angioplasty, with or without stenting, with a regular angioplasty balloon catheter (n=52). Patients who did not receive a stent were prescribed one month of clopidogrel; patients who were stented--12 in the drug-coated balloon group and 14 in the regular-angioplasty group--were given clopidogrel for three months.

Six-month average late lumen loss, the trial's primary end point, was 0.46 mm in patients in the paclitaxel-coated-balloon group, compared with 1.09 mm for the conventional-angioplasty control group (p=0.016). There was also a nonsignificant trend in favor of the drug-coated balloon for target lesion revascularization, 13% vs 22%. Also, at six months, 72% of the drug-coated-balloon group had patent vessels, defined as <50% diameter stenosis with no target lesion revascularization, compared with 49% of the control group. There were no thromboses in the drug-coated-balloon group and two in the regular-balloon group.

Late lumen loss and patency rates were better with the drug-coated balloon in both the stented and nonstented patients, but the study was not powered to show differences in those subgroups.

The study shows the paclitaxel-coated balloon has a "strong biologic effect demonstrated on the inhibition of neointimal hyperplasia," Scheinert said. The data also suggest that the drug-coated balloon may be safe with a shorter duration of antiplatelet therapy, but all of these results must be confirmed in a larger, longer study.

Dr Thomas Zeller

Commenting on the study at the conference, Dr Thomas Zeller (Herzzentrum Bad Krozingen, Germany) said, "The strength of the study is its confirmation of formerly published data on the controlled release [of paclitaxel in treating femoropopliteal disease]." He pointed out that the late-lumen loss numbers were not as good for the drug-coated balloon in the LEVANT I study as in some previous research, but that this study was a milestone because it was the first to compare the drug-coated balloon catheter and a plain balloon catheter in both stent and nonstent procedures.

Scheinert acknowledged that data from more patients over a longer period are needed to prove this device is preferable to a traditional peripheral balloon. Those data are expected to come from the international LEVANT II trial, which Lutonix hopes will begin by the end of 2010 and eventually support FDA approval of the Moxy. The primary efficacy end point for LEVANT II is one-year primary patency of the target lesion. The primary safety end point is a composite of freedom from all-cause perioperative and one-year index limb amputation, index limb reintervention, and index-limb-related death.