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LEVANT 2 published: DCB superior to standard angioplasty for treatment of PAD
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Results of the LEVANT 2 trial, originally presented at TCT 2013 and now published in The New England Journal of Medicine, demonstrate the use of a paclitaxel-coated balloon during percutaneous transluminal angioplasty was associated with a significantly greater rate of primary patency at 1 year compared with standard angioplasty in patients with symptomatic femoropopliteal peripheral arterial disease.
Further, safety findings show that the drug-coated balloon (Lutonix 035, Lutonix-Bard) was noninferior to standard angioplasty.
The randomized, single blind study included 476 patients at 54 centers in Europe and the United States. Eligibility criteria included intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions. Baseline data indicated that 42.9% of the cohort also had diabetes and 34.7% were current smokers.
Patients were randomly assigned in a 2:1 ratio to standard angioplasty or angioplasty with a paclitaxel-coated balloon.
The primary efficacy endpoint, primary patency of the target lesion at 12 months, was superior in the paclitaxel-coated balloon group vs. the standard angioplasty group (65.2% vs. 52.6%; P = .02).
The primary safety endpoint was a composite of freedom from limb-related death, amputation and reintervention at 12 months and freedom from perioperative death from any cause. Overall, 83.9% of patients who received the paclitaxel-coated balloon were free of safety events compared with 79% of patients who received standard angioplasty (P = .005 for noninferiority).
Kenneth Rosenfield
Both groups had similar functional outcomes and rates of major amputation (paclitaxel-coated balloon 0.3% vs. standard angioplasty 0%; P = .37), death (2.4% vs. 2.8%; P = .82), reintervention for thrombosis (0.4% vs. 0.7%; P = .62), total target lesion revascularization (12.3% vs. 16.8%; P = .21) and total target vessel revascularization (13.3% vs. 18.2%; P = .19).
“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. In addition, further studies may compare the [DCB] with other therapeutic options, such as atherectomy or stenting with bare-metal stents or drug-eluting stents,” Kenneth Rosenfield, MD, and colleagues wrote. – by Rob Volansky
Disclosure: LEVANT 2 was supported by Lutonix-Bard. Rosenfield reports a research contract to his institution for conduct of the trial from Lutonix/Bard and financial relationships with Abbott Vascular, Atrium, Cordis, NIH and VIVA Physicians.
Perspective
Back to TopWilliam Gray, MD
This is an important study as it is the first DCB tested and the first trial completed in the United States under rigorous FDA standards. It demonstrates the proof of concept that an antiproliferative drug placed on a balloon can be deposited at the site of treatment and have a measurable effect on restenosis in the femoropopliteal arterial segment. This is just the start of what promises to be a whole new category of therapeutic devices: DCBs. I would anticipate that future devices, including IN.PACT Admiral Drug-Coated Balloon, will build on the positive outcomes seen here even more robustly, in similar and even more complex lesion sets. Ultimately, these evolutionary benefits will accrue to the benefit of the patients we treat.
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