A systematic review of covered balloon-expandable stents for treating aorto-iliac occlusive disease.

Abstract Objective To evaluate and compare studies reporting the outcomes of the use of covered balloon-expandable stents for the treatment of aorto-iliac occlusive disease. Methods A systematic literature search was conducted to identify studies that investigated the use of covered balloon-expandable stents for the treatment of aorto-iliac occlusive disease and were published between 2000 and 2019. Baseline demographic data, procedural variables, and long-term outcomes were extracted from publications for analysis. Results A total of 15 published articles about 14 studies were included in the review. Of these, eight studies were prospective clinical trials and six studies were retrospective real-world studies. The articles included data regarding five different covered balloon-expandable stents, namely, iCast/Advanta V12, Viabahn VBX, BeGraft, LifeStream, and JOSTENT. Lesion severity was higher in real-world studies, with more TransAtlantic InterSociety Consensus Classification D lesions and a higher percentage of occlusions. All studies showed high rates of technical success and patency over the course of 12 months. Long-term data were only available for the iCast/Advanta V12 device, which had a primary patency rate of 74.7% at 5 years. Conclusions Covered balloon-expandable stents are a viable treatment option for patients with complex aorto-iliac lesions because of their high rates of technical success and favorable patency across all devices at 12 months. However, long-term data are only available for a single device, the iCast/Advanta V12. The results of using this device were favorable over the course of 5 years.