Data from the LEVANT 2 trial comparing the Lutonix drug-eluting balloon with angioplasty alone in the treatment of peripheral arterial disease show that the primary endpoints of both safety and efficacy were met and superior efficacy and non-inferior safety of Lutonix compared to control angioplasty was demonstrated.
BARD submitted the one-year results of the LEVANT 2 study to the FDA Circulatory System Devices Advisory Panel and on 12 June 2014, the panel voted unanimously to recommend the approval of the device in the United States. The results of the LEVANT 2 trial have been submitted for publication in a peer-reviewed journal.
In the LEVANT 2 trial, the primary efficacy endpoint for the Lutonix drug-eluting balloon was primary patency at 12 months defined as freedom from both restenosis and target lesion revascularisation. Primary patency for Lutonix was 65.2% which was superior to control angioplasty (52.6%, p=0.015) demonstrating superior efficacy. At six months, the primary patency rate was 92.3% for the drug-eluting balloon vs. 82.7% for angioplasty alone (p=0.003).
The primary safety endpoint for Lutonix was freedom from perioperative death and 12-month index limb amputation (above and below the ankle), index limb re-intervention and index-limb related death. The primary safety endpoint rate for Lutonix (83.9%) was non-inferior to control angioplasty (79%, p=0.005). At six months, the rates were similar (94% vs. 94.1%).
At 12 months, the freedom from target lesion revascularisation in the Lutonix group was 87.7% compared to 83.2% in the control group (p=0.208). Unlike prior femoropopliteal premarket approval studies, bailout stenting was not counted as a failure; a post-hoc analysis with procedural stenting counted as a target lesion revascularisation was conducted, and a higher freedom from target lesion revascularisation rate for Lutonix (85.3%) compared to control angioplasty (76.4%, p=0.017) was observed at 12 months.
In April 2014, Medtronic released at the Charing Cross Symposium the one-year results of the IN.PACT SFA trial. In the study, the IN.PACT Admiral drug-eluting balloon was significantly superior to angioplasty. The primary patency rate achieved with the drug-eluting balloon was 82.2% and for angioplasty it was 52.45% (p<0.001). Freedom from clinically driven target lesion revascularisation was 97.6% with the drug-eluting balloon and 79.4% with angioplasty (p<0.001).
In a press release, BARD said that 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 bailout 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 company stated.