Key result
VBX stent graft nearly triples 24-month primary patency odds vs V12/iCast in aortoiliac disease.
Why the study?
The safety and effectiveness of covered balloon-expandable stent grafts for treating aortoiliac occlusive disease have not been comprehensively analyzed across studies from 2000 to 2024.
Do covered balloon-expandable stent grafts provide effective patency and freedom from target lesion revascularization in patients with aortoiliac occlusive disease?
Meta-Analysis (n=1,983)
Do covered balloon-expandable stent grafts provide effective patency and freedom from target lesion revascularization in patients with aortoiliac occlusive disease?
Covered balloon-expandable stents demonstrate high long-term patency and freedom from target lesion revascularization in aortoiliac occlusive disease, with potential differences in efficacy between specific stent types.
Answers are grounded in this paper and cite their sources.
Should not yet change AIOD practice with CBE stents; leaves open need for confirmatory RCTs.
PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.
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Piazza et al. (2025) conducted a meta-analysis in Aortoiliac occlusive disease (AIOD) (n=1,983). VBX Stent Graft vs. V12/iCast Stent Graft was evaluated on Primary patency at 24 months (OR 2.8, p=≤ .05). In patients with aortoiliac occlusive disease, the VBX Stent Graft demonstrated higher primary patency at 24 months compared to the V12/iCast Stent Graft.
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