A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing Drug-Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries - LEVANT 2
The goal of the trial was to evaluate treatment with a drug-coated balloon compared with conventional balloon angioplasty among patients with femoropopliteal disease.
A drug-coated balloon will improve vessel patency.
- Patients ≥18 years of age with significant femoropopliteal disease (Rutherford class 2-4)
- Lesions need to be ≤15 cm, diameter 4-6 mm, ≥70% stenosis, and no in-stent restenosis
Number of enrollees: 476
Duration of follow-up: 6 months
Mean patient age: 68 years
Percentage female: 39%
- Freedom from all-cause perioperative death and freedom from amputation, re-intervention, or index limb-related death at 1 year (safety outcome)
- Primary patency of target lesion at 1 year (efficacy outcome)
Patients with significant femoropopliteal disease were randomized to drug-coated balloon angioplasty versus conventional balloon angioplasty. Prior to randomization, all patients underwent conventional balloon angioplasty with a 1 mm undersized balloon.
Overall, 476 patients were randomized. The mean age was 68 years, 61% were men, 43% had diabetes, and mean ankle-brachial index was 0.7. Bailout stenting was performed in 2.5% of the drug-coated balloon group versus 6.9% of the conventional balloon group (p = 0.022).
At 6 months, freedom from the composite safety outcome occurred in 94.0% of the drug-coated balloon group versus 94.1% of the conventional balloon group (p = 0.96). Primary patency occurred in 92.3% of the drug-coated balloon group versus 82.7% of the conventional balloon group (p = 0.003).
- Freedom from target lesion revascularization: 96.0% vs. 96.0% (p = 0.96), respectively, for drug-coated balloon vs. conventional balloon angioplasty
- Binary restenosis: 17.4% vs. 33.8% (p < 0.001), respectively
- Death: 0.7% vs. 1.3% (p = 0.50), respectively
- Amputation: 0.3% vs. 0 (p = 0.37), respectively
Among patients with significant femoropopliteal disease, treatment with a drug-coated balloon is feasible. This treatment strategy appeared to be safe and improved primary vessel patency. Longer-term follow-up is needed.
Presented by Dr. Kenneth Rosenfield at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2013), San Francisco, CA, October 30, 2013.
Keywords: Follow-Up Studies, Coronary Restenosis, Ankle Brachial Index, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Diabetes Mellitus, Stents
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