Clinical outcome of endovascular therapy using a VIABAHN VBX-covered stent for complex aortoiliac artery disease: the AVOCADO II study

AbstractClinical trials have demonstrated the efficacy of a balloon-expandable covered stent (CS) for aortoiliac occlusive disease (AIOD). However, the real-world clinical outcomes and the underlying factors remain unclear. We assessed the clinical outcomes and factors associated with primary patency after implantation of a balloon-expandable CS for patients with complex AIOD. This prospective multicenter observational study enrolled 149 consecutive patients undergoing VIABAHN® VBX-CS (W.L. Gore& Associates, Flagstaff, AZ) implantation for complex AIOD (age, 74  ± 9 years; male, 74%; diabetes mellitus, 46%; renal failure on dialysis, 23%; chronic limb-threatening ischemia, 26%). The primary study endpoint was 1-year primary patency, and the secondary endpoints were procedural complications, freedom from occlusion, clinical-driven target lesion revasc ularization (CD-TLR), and surgical revision at 1 year. Risk factors for restenosis were explored using random survival forest analysis. The median follow-up period was 13.1 months (interquartile range 9.7–14.0 months). Procedural complications were observed in 6.7% of the patients. The 1-year p rimary patency was 94.8% (95% confidence interval 91.0–98.6%), while the 1-year freedom rate from occlusion, CD-TLR, and surgical revision rates were 96.5% (93.5–99.5%), 94.7% (90.9–98.6%), and 97.8% (95.4–100%), respectively. The presence of chronic total occlusion, aortic bifurcation lesio n, the number of disease...
Source: Heart and Vessels - Category: Cardiology Source Type: research