Kenneth Ouriel1, Daniel G. Clair2, K. Craig Kent3, Christopher K. Zarins4, for the Positive Impact of Endovascular Options for Treating Aneurysms Early Investigators
1NewYork Presbyterian Hospital, New York, NY; 2Cleveland Clinic Foundation, Cleveland, OH; 3University of Wisconsin, Madison, WI; 4Stanford University Medical Center, Stanford, CA
OBJECTIVES: While repair of large abdominal aortic aneurysms is well accepted, randomized clinical trials have failed to demonstrate benefit for early surgical repair of small aneurysms over surveillance. Endovascular repair has been demonstrated to be safer than open surgical repair in patients with large aneurysms, prompting a randomized trial of early endovascular repair versus surveillance in patients with small aneurysms.
METHODS: We randomized patients with 4 to 5 cm abdominal aortic aneurysms to early endovascular repair or ultrasound surveillance. Rupture or aneurysm-related death and overall mortality were compared in the two groups during a mean (± SD) follow-up of 20 ± 12 months.
RESULTS: 728 patients with small aneurysms (4.5 ± 0.3 cm in diameter) were randomly assigned to early endovascular repair (366 patients) or ultrasound surveillance (362 patients). The mean age of the patients was 71 ± 8 years and approximately 13 percent were women. After mean follow-up of 20 ± 12 months (range 0 to 41 months), there were 15 deaths in each group (4.1 percent) and the unadjusted hazard ratio for mortality after early endovascular repair was 1.01 (0.49, 2.07, P = 0.98). Aneurysm rupture or aneurysm-related death occurred in two patients in each group (0.6%). The unadjusted hazard ratio was 0.99 (0.14, 7.06, P = 0.99) for early endovascular repair.
CONCLUSIONS: Both early treatment with endovascular repair and rigorous ultrasound surveillance appear to be safe alternatives for patients with small abdominal aneurysms, protecting the patient from rupture or aneurysm-related death up for at least 3 years.
AUTHOR DISCLOSURES: K. Ouriel, None; D.G. Clair, None; K.C. Kent, Grants/Research Support: Gore, Medtroic, Consultant: Organovo; C.K. Zarins, Grants/Research Support: Medtronic, Consultant: Medtronic.