CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
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A 5-year comparison of EVAR for large and small aortic necks.

PURPOSE: To compare the long-term outcomes of endovascular aneurysm repair (EVAR) using the Talent endograft for abdominal aortic aneurysms (AAAs) with large and small aortic necks.

METHODS: Data on 156 patients (142 men; mean age 74.1 years, range 41-89) with adequate preoperative imaging were obtained from the prospective, nonrandomized, multicenter Talent eLPS trial, which enrolled patients from February 2002 to April 2003. Subgroup analyses were performed for AAAs with a large aortic neck diameter (≥28 mm; n=53, group 1) and those with smaller necks (<28 mm; n=103, group 2). Safety and effectiveness endpoints were evaluated at 30 days, 1 year, and 5 years post procedure.

RESULTS: Patients in both groups had similar gender and risk factor profiles. However, group 1 was significantly older (mean age 76.5 versus 72.9 years; p<0.01). Aside from neck diameter, the 2 groups had similar mean neck length and angulation. Group 1 also had a larger maximum aneurysm diameter (mean 58.2 versus 53.4 mm; p<0.01). At 1 year, the 2 groups had similar effectiveness endpoint results. There was a significantly lower freedom from major adverse events (MAEs) for group 1 at 30 days (79.2% versus 95.1%; p<0.01). While this trend continued to 1 year, the difference lost statistical significance (72.0% versus 85.1%; p=0.08). Freedom from all-cause mortality at 30 days (94.4% versus 100%; p<0.04) and aneurysm-related death at 1 year (93.3 versus 100%; p<0.04) also was significantly lower for group 1. At 5 years, there were no significant differences in the rates of endoleaks or aneurysm changes. The 5-year rates for freedom from aneurysm-related mortality for groups 1 and 2 were 91.2% and 98.7% (p=NS), respectively. There were 5 instances of migration in this study, all occurring in group 1 patients.

CONCLUSION: AAAs with aortic necks ≥28 mm can be treated with endovascular devices with acceptable results at 5 years. However, these patients have a higher rate of MAEs within the first year and higher migration rates at 5 years. In addition, they have a lower freedom from all-cause mortality at 30 days and aneurysm-related death at 1 year. Careful patient selection, accurate device deployment, and continued follow-up are necessary to optimize long-term results in this patient population.

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