Objectives: The Global SFA Registry sought to assess safety, clinical benefit, and outcomes of the Lutonix 035 drug-coated balloon (DCB) in a heterogeneous, real-world patient population at 12 and 24 months.
Background: Numerous clinical studies have evaluated the use of angioplasty for revascularization of femoropopliteal arteries in peripheral arterial disease with restenosis rates of 40% to 60% at 6 to 12 months. Data from recent studies document decreased restenosis rates and improvement in patency in patients receiving angioplasty of femoropopliteal arteries with DCBs.
Methods: The multicenter, prospective study enrolled 691 patients in 38 centers from 10 countries 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.
Results: Freedom at 30 days from the composite safety endpoint was 99.4%. Freedom from target lesion restenosis was 93.4%/89.3% for the overall population, 93.2%/88.2% for long lesions up to 500 mm, and 90.7%/84.6% for in-stent restenosis at 12/24 months. Clinically assessed primary patency by Kaplan-Meier estimates was 85.4%/75.6% at 12/24 months. More than 76% of patients showed improvement of at least 1 Rutherford category.
Conclusions: The Global SFA Registry 24-month outcomes confirm the Lutonix 035 DCB is a safe and effective long-term treatment option in real-world patients with peripheral arterial disease with superficial femoral artery lesions, also in long lesions and in-stent restenosis. (Lutonix Global SFA Registry; NCT01864278).
Keywords: amputation; angioplasty; drug-coated balloon; paclitaxel; peripheral artery disease; restenosis.
Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.