Frank A. Lederle MD1, Julie A. Freischlag MD2, Tassos C. Kyriakides PhD3 for the Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group
1Veterans Affairs Medical Center, Minneapolis, MN; 2Veterans Affairs Medical Center, Baltimore, MD; 3Veterans Affairs Medical Center, West Haven, CT
OBJECTIVES: To compare long term mortality and other outcomes after endovascular or open repair of abdominal aortic aneurysm (AAA).
METHODS: Patients with eligible AAA at 42 Veterans Affairs medical centers were randomized to endovascular (n=444) or open (n=437) repair and followed for up to 9 years (mean 5.2 years).
RESULTS: Randomized patients were 99% male with mean age of 70 years and mean maximum AAA diameter of 5.7 cm. For the primary outcome of all cause mortality, 145 deaths occurred in the endovascular group and 144 in the open group, hazard ratio 0.98 (95% CI 0.78, 1.23, P =0.86). The previously reported reduction in peri-operative mortality (30 days or inpatient) with endovascular repair was sustained at 2 years (HR 0.63, CI 0.40-0.98, p = .04) and 3 years (HR 0.72, CI 0.51, 1.00, p < .05), but not thereafter. Ten AAA-related deaths occurred (3.7%, 2 perioperative and 8 late) in the endovascular repair group compared with 16 (2.3%, 13 peri –operative and 3 late) in the open repair group (difference -1.4%, CI -3.7, 0.83, p=0.25). Five AAA ruptures were confirmed, all in the endovascular repair group, 3 of them fatal. There were 146 secondary therapeutic procedures in 96 patients in the endovascular repair group and 101 procedures in 77 patients in the open repair group (NS).
CONCLUSIONS: The early survival advantage of endovascular repair was sustained for 3 years, after which there was no difference between the 2 groups. The occurrence of ruptures after endovascular repair remains concerning.
AUTHOR DISCLOSURES: F. Lederle MD, Nothing to Disclose; J. Freischlag MD, Nothing to Disclose; T. Kyriakides PhD, Nothing to Disclose.
Updated May 2012