FROM THE NEW ENGLAND JOURNAL OF MEDICINE

For patients who have femoropopliteal peripheral artery disease, percutaneous transluminal angioplasty with a paclitaxel-coated balloon achieves better 1-year patency than does using a standard balloon, according to a report published online June 24 in the New England Journal of Medicine.

Angioplasty initially restores blood flow in most patients with this type of PAD, but more than 60% develop restenosis from vessel recoil and neointimal hyperplasia within 1 year. The LEVANT2 (Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis) clinical trial assessed the performance of a drug-coated balloon (316 patients) against a standard balloon (160 patients) in participants treated at 54 sites in the U.S. and Europe, said Dr. Kenneth Rosenfield of Massachusetts General Hospital, Boston, and his associates.

The primary efficacy endpoint – the rate of patency of the target lesion at 1 year – was significantly higher with the paclitaxel-coated balloon (65.2%) than with the standard balloon (52.6%), the investigators said (N. Engl. J. Med. 2015 June 24 [doi:10.1056/NEJMoa1406235]).

However, secondary efficacy endpoints including the rates of event-free survival (86.7% vs. 81.5%), target-lesion revascularizations (12.3% vs. 16.8%), overall mortality (2.4% vs. 2.8%), amputation (0.3% vs. 0.0%) and thrombosis (0.4% vs. 0.7%) were not significantly different between the two study groups. Scores on a measure of walking distance improved significantly more with the paclitaxel-coated balloon, but ankle-brachial index and Rutherford scores measuring pain and symptoms of intermittent claudication did not differ significantly between the two study groups.

The primary safety endpoint – a composite of the proportion of patients free from perioperative death from any cause plus the proportion free from amputation, reintervention, or PAD-associated death at 1 year – was 83.9% with the paclitaxel-coated balloon and 79.0% with the standard balloon. This met the criterion for noninferiority.

“Our trial does not provide definitive guidance concerning the potential role of this paclitaxel-coated balloon in clinical practice. 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,” Dr. Rosenfield and his associates said.

This study was funded by Lutonix-Bard, maker of the paclitaxel-coated balloon. Dr. Rosenfield reported ties to Lutonix/Bard, Cordis, Atrium, Abbott Vascular, and VIVA Physicians; his associates reported ties to numerous industry sources.

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