A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing Drug-Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries - LEVANT 2

Oct 30, 2013
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Lutonix/C.R. Bard
Date Presented:
01/01/2013
Date Updated:
10/30/2013
Original Posted Date:
10/30/2013
References

Description:

The goal of the trial was to evaluate treatment with a drug-coated balloon compared with conventional balloon angioplasty among patients with femoropopliteal disease.

Hypothesis:

A drug-coated balloon will improve vessel patency.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • 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%

Primary Endpoints:

  • 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)

Drug/Procedures Used:

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.

Principal Findings:

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

Interpretation:

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.

References:

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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