Bard's Lutonix Global SFA Registry 24-Month Results Published

August 3, 2017—The 24-month results of the Lutonix Global SFA Registry, evaluating the worldwide experience with the Lutonix drug-coated balloon (DCB; Bard Peripheral Vascular, Inc.), were published online by Marcus Thieme, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions. The registry assessed the safety, clinical benefit, and outcomes of the Lutonix 035 DCB in a heterogeneous, real-world patient population at 12 and 24 months.

The Lutonix Global SFA Registry is a multicenter, prospective study that enrolled 691 patients at 38 centers in 10 countries who were treated with the Lutonix 035 DCB in femoropopliteal lesions. The primary safety endpoint was freedom from a composite of target vessel restenosis, major index limb amputation, and device- or procedure-related death at 30 days. The primary effectiveness endpoint was freedom from target lesion restenosis at 12 months. Secondary endpoints were acute device and procedural success and clinically assessed primary patency.

As summarized in JACC: Cardiovascular Interventions, freedom at 30 days from the composite safety endpoint was 99.4%. At 12 and 24 months, respectively, freedom from target lesion restenosis was 93.4% and 89.3% for the overall population, 93.2% and 88.2% for long lesions up to 500 mm, and 90.7% and 84.6% for in-stent restenosis. Clinically assessed primary patency by Kaplan-Meier estimates was 85.4% at 12 months and 75.6% at 24 months. More than 76% of patients showed improvement of at least one Rutherford category.

The 24-month outcomes confirm that the Lutonix 035 DCB is a safe and effective long-term treatment option in real-world patients with peripheral artery disease and superficial femoral artery lesions, as well as in long lesions and in-stent restenosis, concluded the investigators in JACC: Cardiovascular Interventions.