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

• Published in: Heart and vessels 2023-10, Vol.38 (10), p.1288-1297
• Main Authors: Tomoi, Yusuke, Takahara, Mitsuyoshi, Soga, Yoshimitsu, Hata, Yosuke, Iida, Osamu, Yamaoka, Terutoshi, Hayakawa, Naoki, Fujihara, Masahiko, Ando, Kenji
• Format: Article
• Language: English
• Subjects: Aorta; Balloon treatment; Biomedical Engineering and Bioengineering; Calcification; Cardiac Surgery; Cardiology; Cardiovascular system; Clinical outcomes; Clinical trials; Complications; Confidence intervals; Diabetes mellitus; Dialysis; Implantation; Implants; Ischemia; Lesions; Medicine; Medicine & Public Health; Observational studies; Occlusion; Original Article; Renal failure; Restenosis; Revisions; Risk factors; Stents; Surgical implants; Vascular Surgery
• ISSN: 0910-8327; 1615-2573
• DOI: 10.1007/s00380-023-02274-5

Clinical 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 revascularization (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 primary 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 lesion, the number of disease regions, and TASC-II classification was significantly associated with the restenosis risk. In contrast, the calcification severity, IVUS use, IVUS parameters were not associated with restenosis risk. We observed excellent 1-year real-world outcomes after implantation of a balloon-expandable CS for complex AIOD; only a few perioperative complications occurred.