Lutonix Global SFA Registry Results Show Safety and Efficacy for Bard's DCB

November 3, 2015—The 12-month and interim 24-month outcomes from the Lutonix Global SFA Registry were presented by D. Christopher Metzger, MD, during the second of two Late-Breaking Trials sessions at VIVA 15, the 13th annual Vascular InterVentional Advances meeting. The meeting, which is sponsored by VIVA Physicians, Inc., is being held November 2–5, 2015, at the Wynn Las Vegas in Las Vegas, Nevada. The session moderators are Michael R. Jaff, DO, and Krishna Rocha-Singh, MD.

According to VIVA, the prospective, global, multicenter, single-arm, real-world registry is investigating the clinical use and safety of the Lutonix drug-coated percutanous transluminal angioplasty dilatation catheter (Bard Peripheral Vascular) in the treatment of disease of the superficial femoral artery. The primary endpoints were effectiveness and safety. Effectiveness was defined as freedom from target lesion revascularization (TLR) at 12 months. Safety was defined as freedom from target vessel revascularization at 30 days, major index limb amputation, and device- or procedure-related death.

The study enrolled a total of 691 patients in 10 countries at 38 centers in Europe from December 2012 to July 2014. Key inclusion criteria were Rutherford category ≤ 4, stenotic or obstructive vascular lesion of the femoropopliteal artery treated per the instructions for use, and at least one patent native outflow artery to the ankle free from significant lesion (≥ 50% stenosis) by angiography. All serious adverse events were adjudicated.

The patient population consisted of 68% males, 39.5% diabetics, 85.1% hypertension, and 70% dyslipidemia. The mean lesion length was 101.2 ± 84.2 mm with a range of 23 to 500 mm, treated length was 136.6 ± 89.7 mm, and mean reference vessel diameter was 5.2 ± 0.67 mm. Of the included lesions, 50.2% had calcification, 31.2% were chronic total occlusions (CTOs), 20.3% were long lesions (140–500 mm), and 30% were in the popliteal artery.

Safety at 30 days was 99.7%, and 12-month freedom from TLR was 94.3%. Females, patients with calcification, and patients with CTOs had a freedom from TLR rate of 90%, 95.9%, and 94.8%, respectively. A subgroup of patients with long lesions (140–500 mm; mean, 212.3 ± 65.3 mm) had a freedom from TLR rate of 93.7%. There were no device- or procedure-related deaths reported.

Dr. Metzger concluded that the Lutonix Global registry demonstrates that the Lutonix drug-coated balloon is safe and effective in a real-world patient population, including women. Treatment benefit was also demonstrated at 12 months in subgroups with lesions up to 500 mm, calcified lesions, and CTOs.