One-Year Clinical Outcomes of a Self-Expanding Covered Stent for Aortoiliac Occlusive Disease

To report 1-year outcomes of real-world clinical data from patients with de novo or restenotic iliac artery lesions treated with the GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface (VSX) device.

Devices were implanted to treat de novo atherosclerotic or restenotic iliac artery lesions. The primary endpoint was freedom from device-related serious adverse events (SAEs) at 1 year. Additional endpoints included descriptive analyses and Kaplan-Meier estimates of primary patency, primary-assisted patency, and secondary patency; freedom from major amputation, freedom from target lesion revascularization (fTLR); and changes in Rutherford classification and the Ankle Brachial Index (ABI).

The 100 patients were treated, mean age 66.9 years and 75.0% male, had a mean (±SD) lesion length of 102±60.9 mm and 62.2% were chronic total occlusions; 70.6% were classified as Trans-Atlantic Inter-Society Consensus Document (TASC) C/D, and 20 lesions were across the inguinal ligament. Maximum stenosis was 88.6±17.9%. Technical success was 100%. At 1 year, there were no device-related deaths, 97.8% of patients were free from device-related SAEs, and 99.0% were free from major amputations. Estimates of lesion primary patency, primary-assisted patency, and secondary patency were 95.0% (confidence interval [CI]=87.1, 98.1), 96.3% (CI=89.0, 98.8), and 97.4% (CI=90.1, 99.4), respectively; fTLR was 96.2% (CI=90.1, 98.5). Patients with restenotic lesions and patients <60 years old had lower primary patency, primary-assisted patency, and fTLR rates. Change from baseline to 1 year in the mean ABI was 0.56±0.17 to 0.88±0.15. The rate of asymptomatic patients (Rutherford 0) was 1.0% at baseline and 63.2% at 1 year; patients with intermittent claudication decreased from 52.0% to 35.1%, and critical limb-threatening ischemia from 37.0% to 1.8%.

The European registry 1-year outcomes demonstrated the safety and effectiveness of the VSX device in the treatment of iliac lesions evidenced by high patency, no device-related deaths, and low numbers of major amputation and reintervention procedures.Clinical ImpactThe European registry reflecting a 'real-world' setting of patients treated with the GORE^® VIABAHN^® Endoprosthesis with PROPATEN Bioactive Surface for aortoiliac occlusive disease demonstrated that the self-expanding covered stent was a safe and effective treatment option. At 1 year, 83% of patients had no-to-minimal pain and discomfort and 77% of patients rated no-to-slight mobility impairment issues (5Q-5D-5L assessment). There were no device-related deaths, only 1 amputation, and few reintervention procedures. This study revealed that patients younger than 60 years old or those treated for restenosis had greater risk for target lesion revascularization, device- or limb-related serious adverse events.