Systematic Literature Review and Meta-analysis of Covered Balloon-Expandable Stents for Aortoiliac Occlusive Disease

To analyze the safety and effectiveness of covered balloon-expandable (CBE) stent grafts for treatment of aortoiliac occlusive disease (AIOD) from publications between 2000 and 2024.

A PubMed systematic literature review search was conducted to expand a previous review (2000-2019) and include publications between 2020 and 2024. Terms included balloon-expandable/expanding, iliac, and specific stent graft names. Study eligibility criteria included ≥5 patients with AIOD treated with CBE stents and reports of patency or freedom from target lesion revascularization (fTLR). Primary, primary-assisted, and secondary patency and fTLR rates at 1, 6, 9, 12, 24, 36, 48, and 60 months were analyzed.

The search identified 252 records; 25 studies (29 publications) met eligibility, resulting in 1,983 patients included in the meta-analysis. The stent grafts included Advanta V12 Balloon Expandable Covered Stent/iCast Covered Stent System (Advanta V12/iCast; Getinge Maquet, Rastatt, Germany), GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX Stent Graft; W. L. Gore & Associates, Inc. Flagstaff, Arizona), BeGraft Peripheral Stent Graft System and/or BeGraft Peripheral Plus Stent Graft (Bentley InnoMed GmbH, Hechingen, Germany), LifeStream Balloon Expandable Vascular Covered Stent (Becton Dickenson, Tempe, Arizona), iCover Stent Graft (iVascular, Barcelona, Spain), and mixed-device cohorts. Pooled stent graft primary patency rates at 12, 24, 36, 48, and 60 months were 91%, 85%, 81%, 79%, and 80%, respectively, and fTLR rates were 94%, 91%, 87%, 84%, and 85%, respectively. Primary patency was higher (P ≤ .05) for VBX Stent Graft than that for V12/iCast Stent Graft at 6 months (odds ratio [OR], 3.1), 12 months (OR, 2.2), and 24 months (OR, 2.8). The fTLR was also higher for VBX Stent Graft at 24 months (OR, 1.8; P = .042).

This updated systematic review and meta-analysis and findings, although observational and not confirmatory, add to the body of evidence supporting the clinical utility of CBE stents in managing AIOD.