Luntonix Global SFA Registry: DCB effective, safe at 1 year

LAS VEGAS — New data from the Lutonix Global SFA Registry demonstrate that the rate of freedom from target lesion revascularization at 1 year was 94.3% in real-world patients with complex femoropopliteal lesions who received a drug-coated balloon, researchers reported at VIVA 15.

During a late-breaking clinical trials session, D. Christopher Metzger, MD, FACC, FSCAI, from Wellmont CVA Heart Institute in Kingsport, Tennessee, said the Lutonix 035 Drug-Coated Balloon PTA Catheter (Bard Peripheral Vascular) demonstrated safety and clinical effectiveness in a real-world setting.

Metzger presented 1-year findings on 691 patients enrolled at 38 sites across 10 European countries from December 2012 to July 2014. Mean target lesion length was 101.2 mm and 30% involved the popliteal artery. More than three-quarters of patients had Rutherford class 3 or higher.

The primary efficacy endpoint was freedom from TLR at 1 year and the primary safety endpoint was defined as freedom from target vessel revascularization, major limb amputation and device- or procedure-related death at 30 days.

Positive safety results were achieved in 99.7% of patients, Metzger said during the presentation.

In other results, the rate of all-cause death was 2.5%, major limb amputation was 0.5%, minor index limb amputation was 0.5%, reintervention for treatment of embolization to its distal vasculature was 0.5% and reintervention for treatment of thrombosis of the target vessel was 1.1%.

“Subgroup analysis appeared to demonstrate similar effectiveness in a lot of higher-risk lesion subsets, including very long lesions, calcified lesions, chronic total occlusions and in female patients,” Metzger said.

Freedom from TLR was 94.8% in patients with no bailout stenting, 92.7% in those with bailout stenting, 95.9% in those with claudication, 94.8% in those with CTOs and 90.2% in women.

“Some concerns were raised in the pivotal trial in the United States in women,” he said. “Women did well in this trial.”

One-quarter of patients completed 2-year follow-up. Metzger provided the audience with an interim look at the 2-year findings. Freedom from TLR in this cohort was 93% at 2 years.

“The available 24-month data suggest sustained clinical efficacy,” he said.

Results at 2 years also demonstrated similar findings in subgroups analysis.

The presentation also highlighted data on a subgroup of patients with long lesions, defined as those measuring 140 mm to 500 mm (total lesion length, 212.3 mm). In this group, the freedom from TLR at 1 year was 93.7% and the rate of safety at 30 days was 100%. – by Jason Laday

Reference:

Metzger DC, et al. Late-Breaking Clinical Trials. Presented at: VIVA 15; Nov. 2-5, 2015; Las Vegas.

Disclosure: Metzger reports financial ties with Abbott Vascular, Bard, Boston Scientific and Trivascular.