Abstract

To investigate the safety and efficacy of a balloon-expandable covered stent in the treatment of complex aortoiliac artery disease. Peripheral intervention in complex aortoiliac disease still remains a challenge. We retrospectively analyzed symptomatic patients with aortoiliac disease who were treated with GORE® VIABAHN® VBX covered stent (W.L. Gore & Associates, Flagstaff, AZ). The primary study outcome was a 1-year primary patency without the necessity of any subsequent clinically-driven target revascularization (CD-TLR) based intervention. The proportion of technical success, defined in terms of the absence of residual stenosis, stent edge dissection, and procedure-related severe complications, was also reported. VBX covered stent was used in 231 patients. Key patient characteristics include mean age of 73.4 ± 9 years, 77% male, 45% diabetes, and 18% suffering from end-stage renal dysfunction on dialysis. TASC II CD lesions were observed in 51% patients, which included 81% calcified lesions. Combined therapy with standard self-expandable stent was performed in 40% patients. The technical success rate was 92.6%. During median follow-up after 13.1months, the primary patency rate was estimated to be 93.4% (95% confidence interval, 90.0%-96.8%) at 12 months, whereas the rate of freedom from TLR was 95.3% (92.5%-98.2%). As per the univariate analysis, the TASC II classification, number of diseased regions, and chronic total occlusion were significantly associated with risk of restenosis. The results of the year-long AVOCADO study demonstrated that usage of the novel VBX covered stent has a patency-based advantage with reduced chances for subsequent revascularization procedures.

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