Nine-Month Outcomes of the DURABILITY Iliac Study on Self-Expanding Stents for Symptomatic Peripheral Artery Disease

Abstract

The DURABILITY Iliac clinical study evaluated the safety and effectiveness of 2 nitinol self-expanding stents for the treatment of atherosclerotic common and external iliac artery lesions up to 10cm in length and >50% stenosis in subjects with Rutherford classification peripheral arterial disease stages 2-4. DURABILITY Iliac was a prospective, multicenter, core lab adjudicated, nonrandomized clinical study enrolling 75 subjects from 15 sites in the United States and Europe. Clinical follow-up visits were at 30days, 9months, and 1, 2, and 3years after procedure. The primary outcome measured was the major adverse event (MAE) rate at 9months, defined as a composite of periprocedural death, in-hospital myocardial infarction (MI), clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb through 9months after procedure. Secondary outcomes included primary patency rate at 9months, clinically driven target vessel revascularization (CD-TVR), change in ankle-brachial index, and change in Walking Impairment Questionnaire score at 30days and 9months. Device success was defined as the ability to deploy the stent as intended at the treatment site. The MAE rate at 9months was 1.3% (1/75), with 1 subject experiencing a CD-TLR. No periprocedural deaths, MIs, or amputations were reported. Primacy patency at 9months was 95.8%. Freedom from CD-TVR was 98.6% at 9months. Subjects improved in Walking Impairment Questionnaire scores for all categories (walking impairment, walking speed, walking distance, and stair climbing) at the 30-day and 9-month visit. Device success was 100%. The 9-month results of the DURABILITY Iliac study demonstrate the safety and effectiveness of 2 nitinol self-expanding stents for the treatment of atherosclerotic lesions of the common and external iliac arteries.