On 12 June 2014, Bard/Lutonix announced that the US Food and Drug Administration’s (FDA’s) Circulatory System Devices Advisory Panel unanimously recommended that the Lutonix 035 drug-coated balloon over-the-wire percutaneous transluminal angioplasty catheter be approved in the USA.
The Lutonix DCB is currently under review by the FDA for improving luminal diameter and reducing the incidence of restenosis for the treatment of obstructive de novo or non-stented restenotic lesions (≤15cm in length) in native femoropopliteal arteries with reference vessel diameters of 4–6mm. If approved, it is expected that the Lutonix DCB will be the first and only FDA-approved drug-coated balloon available in the USA.
Data presented at the advisory committee meeting included one-year primary endpoint data from the LEVANT 2 pivotal study, which is a global, prospective, single-blind, randomised, 54-site study that enrolled all patients under one protocol. LEVANT 2 investigators have submitted a manuscript for publication with a top-tier medical journal, a press release from the company says.
At one year, LEVANT 2 demonstrated superior primary patency of the target lesion with the Lutonix DCB for the efficacy endpoint (73.5% vs. 56.8%, pèâ0.001 by Kaplan-Meier time-to-event analysis) and non-inferiority for the safety endpoint; both endpoints were compared to standard percutaneous transluminal balloon angioplasty, which is typically the first and preferred method to treat patients with peripheral arterial disease.
The secondary efficacy endpoint results at one year for patients randomised to treatment with the Lutonix DCB demonstrated superiority in binary restenosis (26.5% vs. 43.2%, pèâ0.001 by Kaplan-Meier time-to-event analysis at 365 days) when compared to uncoated balloons, and measurable but not statistically significant improvement in freedom from target lesion revascularisation (89.7% vs. 84.8%, p=0.1673 by Kaplan-Meier time-to-event analysis).
The six-month follow-up results from randomised patients who were treated with the Lutonix DCB demonstrated safety comparable to uncoated balloons (94.0% vs. 94.1%) and superior primary patency (92.3% vs 82.7%, p=0.003) by Kaplan-Meier time-to-event analysis. Repeat revascularisation rates at this interim time point were low and consistent among both groups.
LEVANT 2 was designed to reduce bias in the results in order to accurately and scientifically assess and compare the long-term performance of key clinical measures. Two key aspects of the study design differentiate this trial from other recent superficial femoral artery studies. First, unlike some other trials, the LEVANT 2 clinical trial did not count bail-out stenting as a primary patency or target lesion revascularisation failure. Second, to reduce the potential introduction of bias into the subjective clinical decision for revascularisation, the protocol required the clinical assessment to be performed by a physician who was blinded to the treatment group and the doppler patency measurement, the press release clarifies.
The FDA is not required to follow the recommendations of its advisory panels, but it usually does. Lutonix DCB is available commercially in Europe.