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

Objective: 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.

Methods: 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).

Results: 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%.

Conclusions: 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 Impact: The 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.