Bard Announces 24-Month Results From Lutonix Global SFA Real-World Registry

September 7, 2016—Bard Peripheral Vascular, Inc. announced results from the Lutonix Global SFA Real-World Registry, which assessed the clinical use and outcomes of Bard’s Lutonix 035 drug-coated balloon catheter in the treatment of a heterogeneous population of patients with symptomatic superficial femoral artery and popliteal artery disease in real-world clinical practice.

Bard reported that the multicenter, single-arm, prospective study enrolled 691 patients at 38 sites in 10 countries. Of the patients studied, 39.5% were diabetic, and the target lesion length was 101.2 ± 84.2 mm.

The study met its primary safety and efficacy endpoints, demonstrating 89.2% freedom from target lesion revascularization (TLR) at 24 months and 99.4% safety at 30 days. These findings confirm the positive outcomes reported in the LEVANT 2 trial, noted the company.

By Kaplan-Meier estimates, TLR-free survival was 94.2% at 12 months and 89.2% at 24 months. The primary efficacy endpoint was defined as freedom from TLR at 12 months. The primary safety endpoint was defined as freedom from target vessel revascularization, major index limb amputation, and device- and procedure-related death at 30 days.

Additionally, Kaplan-Meier estimates of the 12-month primary efficacy (TLR free) endpoints were 92.9% for long lesions (> 140 mm), 91.7% for in-stent restenosis, and 89.6% for women. No unanticipated adverse events were reported, advised the company.

In October 2015, Bard announced that the 12-month results from the Lutonix Global SFA Real-World Registry were presented at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium, which was held October 11–15 in San Francisco, California.