Title: LEVANT I: A Prospective Randomized Trial of a Paclitaxel-Eluting Balloon Compared to a Non-Drug-Eluting Balloon With and Without Stenting in Patients with Diseased Femoropopliteal Arteries
Event: TCT 2010
Topic(s): Interventional Cardiology
Presenter: Dierk Scheinert
Writer(s): Xiushui Ren
Date Posted: 09/23/2010
Treatment of peripheral artery stenoses with paclitaxel-eluting balloon catheter (with or without a bare-metal stent) in patients with de novo femoropopliteal arterial disease appears to be safe and reduced late lumen loss compared with use of a non-coated balloon for the procedure.
Background
The success of percutaneous intervention in peripheral arterial disease is limited by restenosis. Paclitaxel-eluting balloon has been shown to be superior to uncoated balloon in patients undergoing angioplasty for femoropopliteal arterial disease.
The current study compared a new paclitaxel-eluting balloon catheter with a noncoated balloon catheter in patients with femoropopliteal arterial disease undergoing percutaneous intervention with or without stents. The new paclitaxel-eluting balloon catheter has a proprietary 2 μg/mm2 paclitaxel coating with hydrophilic non-polymeric carrier that delivers the drug during a single 30-second inflation.
Study Design
This is a prospective, single-blind, randomized, multicenter study of 101 patients with de novo femoropopliteal arterial disease. Patients were stratified prior to randomization into stent or non-stent group. After initial balloon pre-dilatation, patients were randomized to receive paclitaxel-eluting balloon catheter or noncoated balloon catheter treatment.
The primary endpoint was angiographic late lumen loss at 6 months. Secondary endpoints included target-lesion revascularization (TLR), target-vessel revascularization (TVR), primary patency, and safety.
Results and Conclusions
Baseline characteristics were similar between groups. The mean lesion length was 8.7±3.7 cm.
At the end of 6 months, patients treated with paclitaxel-eluting balloon catheter had less late lumen loss as compared with patients treated with noncoated balloon catheter (0.46 mm vs. 1.09 mm, p=0.016). TLR was also numerically less common in the paclitaxel-eluting balloon group (13% vs. 22%, p=Not significant)). The benefit was seen in both balloon and stent groups, although number of patients was smaller in the subgroup analysis.
These data suggest that paclitaxel-eluting balloon treatment in patients is safe and reduces late lumen loss. Larger studies are needed to confirm these results.
References
1. Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65.
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