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Angioplasty with a paclitaxel-coated balloon kept femoropopliteal stenoses open at 1 year better than a standard uncoated balloon, the LEVANT 2 trial showed.
The primary patency rate at 1 year was 65.2% with the Lutonix balloon compared with 52.6% with conventional angioplasty (P=0.02), , of Massachusetts General Hospital in Boston, and colleagues found.
The coated balloon met noninferiority for the primary safety endpoint in the single-blind Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis (LEVANT) 2 trial, reported online in the New England Journal of Medicine.
That composite of freedom from any perioperative death, death from a limb-related medical complication, amputation, and reintervention was maintained for 83.9% with the drug-coated balloon and 79.0% with standard angioplasty (P=0.005 for noninferiority).
The two treatments came out similar on functional outcomes as well as individual rates of death, amputation, thrombosis, or reintervention in the trial, which included 476 patients with moderate to severe intermittent claudication (Rutherford stage 2 or 3) or ischemic pain at rest (Rutherford stage 4) and an angiographically-significant stenosis of at least 70% in the superficial femoral or popliteal artery.
The only significant difference was a better improvement in walking distance score on the Walking Impairment Questionnaire favoring the drug-coated-balloon (difference 9.3 on the 100-point scale).
The lack of a significant advantage on clinically-driven target-lesion revascularization seen in with competitor drug-eluting femoropopliteal balloons could have been because LEVANT 2 wasn't powered for that endpoint or because the rate was lower in the standard angioplasty group than seen in those prior trials, the researchers suggested.
"Our trial does not provide definitive guidance concerning the potential role of this paclitaxel-coated balloon in clinical practice," Rosenfield's group cautioned.
"Although the findings are encouraging, long-term follow-up will be useful in determining whether the benefit of this intervention is sustained, increased, or attenuated over time," they wrote.
Studies comparing drug-coated balloons with other options, like atherectomy or stenting with bare-metal stents or drug-eluting stents, are also needed, they added.
From the American Heart Association:
Disclosures
The study was funded by Lutonix–Bard.
Rosenfield disclosed relationships with Lutonix/Bard, the NIH, Cordis, Atrium, Abbott Vascular, and VIVA Physicians.
Primary Source
New England Journal of Medicine
Source Reference: Rosenfield K, et al "Trial of a paclitaxel-coated balloon for femoropopliteal artery disease" N Engl J Med 2015; DOI: 10.1056/NEJMoa1406235.