The study was conducted to determine the outcome in the United States after endovascular repair (EVAR) of infrarenal abdominal aortic aneurysms (AAAs) in patients at high-risk for open surgery by using independently audited, high-compliance, chart-verified data sets, and to compare those results with open surgery.Methods
High-risk was defined to match a recent European trial (EVAR2) and included age of ≥60 years with aneurysm size of ≥5.5 cm, plus at least one cardiac, pulmonary, or renal comorbidity. Data from five multicenter investigational device exemption clinical trials leading to Food and Drug Administration (FDA) approval were analyzed. Of 2216 EVAR patients, 565 met the high-risk criteria. Of 342 surgical controls (OPEN), 61 met high-risk criteria. Primary outcome comparisons included AAA-related death, all-cause death, and aneurysm rupture. Secondary measures were endoleak, AAA sac enlargement, and migration.Results
Average age of the high-risk EVAR subset was 76 ± 7 years vs 74 ± 6 years OPEN (P = 0.07), mean EVAR AAA size was 6.4 ± 0.8 cm vs 6.6 ± 1.0 cm OPEN (P = .33), and average EVAR follow-up was 2.7 years vs 2.5 years OPEN. The 30-day operative mortality was 2.9% in EVAR vs 5.1% in OPEN (P = .32). The AAA-related death rate after EVAR was 3.0% at 1 year and 4.2% at 4 years compared with 5.1% at both time points after OPEN (P = .58). Overall survival at 4 years after EVAR was 56% vs 66% in OPEN (P = .23). After treatment, EVAR successfully prevented rupture in 99.5% at 1 year and in 97.2% at 4 years.Conclusions
Endovascular repair of large infrarenal AAAs in anatomically suited high-surgical-risk patients using FDA-approved devices in the United States is safe and provides lasting protection from AAA-related mortality. EVAR mortality remained comparable with OPEN up to 4 years. The decision to treat AAAs in patients with advanced age and significant comorbidities must be individualized and carefully considered, but repair provides excellent protection from AAA-related death.