Bard's LEVANT 2 1-Year Data Published in NEJM; 2-Year Data Presented at SVS

June 25, 2015—Kenneth Rosenfield, MD, et al published results from the LEVANT 2 study in the June 24, 2015, online issue of The New England Journal of Medicine. The 1-year results demonstrated superior primary patency for the Lutonix 035 drug-coated balloon (DCB) catheter (Bard Peripheral Vascular, Inc.) over standard percutaneous transluminal angioplasty (PTA), as well as safety consistent with standard PTA balloons for use in patients with symptomatic femoropoliteal peripheral artery disease.

The LEVANT 2 pivotal study is a global, prospective, single-blind, randomized, 54-site study (42 sites in the United States and 12 in Europe) that enrolled all patients under one protocol, comparing the Lutonix 035 DCB with standard PTA. The study met its primary endpoints for safety and efficacy. At 1-year, the study demonstrated approximately 30% improved patency of the Lutonix DCB compared to standard PTA (73.5% vs 58.8%; P < .001 by Kaplan Meier time-to-event analysis).

Dr. Rosenfield, who is Section Head, Vascular Medicine and Intervention, in the Division of Cardiology and Fireman Vascular Center at Massachusetts General Hospital, and served as Principal Investigator for the study, commented, “LEVANT 2 followed a rigorous blinding protocol, which was designed to reduce bias in the results. In addition to superiority in primary patency, the paclitaxel-coated balloon used in the study also demonstrated sustained improvements in Rutherford category from baseline to 12 months, and improved patient-reported walking distance scores.”

In addition to the data published in The New England Journal of Medicine, Bard presented 2-year data from LEVANT 2 last week at the Society for Vascular Surgery’s Vascular Annual Meeting in Chicago.

At 24 months, the rate of primary patency among patients treated with the Lutonix DCB was superior to standard PTA (58.6% vs 53%; P = .05). Rate of freedom from target lesion revascularization (TLR) was 82% for the Lutonix arm. Composite safety at 24 months demonstrated noninferiority and a trend toward superiority over standard PTA (78.7% vs 70.9%; P = .08). 

At 24 months, the secondary safety endpoints for those treated with Lutonix included one major amputation (0.4%), one reintervention for thrombosis (0.4%), and 19 deaths (6.9%).

Also at the meeting, Bard presented results from the company’s global real-world SFA registry. At 12 months, the primary patency rate for patients treated with Lutonix was 91%, and freedom from TLR was 92%. At 24 months, the primary patency rate was 75% and freedom from TLR was 76.4%. Reintervention for treatment of embolization to distal vasculature occurred in 0.5% of cases (n = 75), and reintervention for treatment of thrombosis of the target vessel occurred in 1.2% (n = 74).

The Lutonix DCB received CE Mark approval in 2011 and was approved by the US Food and Drug Administration in October 2014. This approval followed a unanimous favorable recommendation from the agency's Circulatory Systems Devices Advisory Panel, which voted 9 to 0 on each element of safety, efficacy, and benefit/risk. More recently, DCB use has received increased reimbursement for treatment of Medicare beneficiaries in outpatient settings in the United States.