Background: Early elective surgery may prevent rupture of abdominal aortic aneurysms, but mortality is 5-6%. The risk of rupture seems to be low for aneurysms smaller than 5 cm. We investigated whether prophylactic open surgery decreased long-term mortality risks for small aneurysms.
Methods: We randomly assigned 1090 patients aged 60-76 years, with symptomless abdominal aortic aneurysms 4.0-5.5 cm in diameter to undergo early elective open surgery (n=563) or ultrasonographic surveillance (n=527). Patients were followed up for a mean of 4.6 years. If the diameter of aneurysms in the surveillance group exceeded 5.5 cm, surgical repair was recommended. The primary endpoint was death. Mortality analyses were done by intention to treat.
Findings: The two groups had similar cardiovascular risk factors at baseline. 93% of patients adhered to the assigned treatment. 309 patients died during follow-up. The overall hazard ratio for all-cause mortality in the early-surgery group compared with the surveillance group was 0.94 (95% CI 0.75-1.17, p=0.56). The 30-day operative mortality in the early-surgery group was 5.8%, which led to a survival disadvantage for these patients early in the trial. Mortality did not differ significantly between groups at 2 years, 4 years, or 6 years. Age, sex, or initial aneurysm size did not modify the overall hazard ratio.
Interpretation: Ultrasonographic surveillance for small abdominal aortic aneurysms is safe, and early surgery does not provide a long-term survival advantage. Our results do not support a policy of open surgical repair for abdominal aortic aneurysms of 4.0-5.5 cm in diameter.