BACKGROUND: Although repair of large abdominal aortic aneurysms (AAAs) is well accepted, randomized clinical trials have failed to demonstrate benefit for early surgical repair of small aneurysms compared with surveillance. Endovascular repair has been shown to be safer than open surgical repair in patients with large aneurysms, prompting a randomized trial of early endovascular repair vs surveillance in patients with small aneurysms. METHODS: We randomly assigned 728 patients (13.3% women; mean age, 71 +/- 8 years) with 4 to 5 cm AAAs to early endovascular repair (366 patients) or ultrasound surveillance (362 patients). Rupture or aneurysm-related death and overall mortality in the two groups were compared during a mean follow-up of 20 +/- 12 months. RESULTS: Among patients randomized to treatment, 89% underwent aneurysm repair. Among patients randomized to surveillance, 31% underwent aneurysm repair during the course of the study. After a mean follow-up of 20 +/- 12 months (range, 0-41 months), 15 deaths had occurred in each group (4.1%). The unadjusted hazard ratio (95% confidence interval) for mortality after early endovascular repair was 1.01 (0.49-2.07, P = .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 = .99) for early endovascular repair. CONCLUSIONS: Early treatment with endovascular repair and rigorous surveillance with selective aneurysm treatment as indicated both appear to be safe alternatives for patients with small AAAs, protecting the patient from rupture or aneurysm-related death for at least 3 years. Copyright (c) 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.
RCT Entities:
BACKGROUND: Although repair of large abdominal aortic aneurysms (AAAs) is well accepted, randomized clinical trials have failed to demonstrate benefit for early surgical repair of small aneurysms compared with surveillance. Endovascular repair has been shown to be safer than open surgical repair in patients with large aneurysms, prompting a randomized trial of early endovascular repair vs surveillance in patients with small aneurysms. METHODS: We randomly assigned 728 patients (13.3% women; mean age, 71 +/- 8 years) with 4 to 5 cm AAAs to early endovascular repair (366 patients) or ultrasound surveillance (362 patients). Rupture or aneurysm-related death and overall mortality in the two groups were compared during a mean follow-up of 20 +/- 12 months. RESULTS: Among patients randomized to treatment, 89% underwent aneurysm repair. Among patients randomized to surveillance, 31% underwent aneurysm repair during the course of the study. After a mean follow-up of 20 +/- 12 months (range, 0-41 months), 15 deaths had occurred in each group (4.1%). The unadjusted hazard ratio (95% confidence interval) for mortality after early endovascular repair was 1.01 (0.49-2.07, P = .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 = .99) for early endovascular repair. CONCLUSIONS: Early treatment with endovascular repair and rigorous surveillance with selective aneurysm treatment as indicated both appear to be safe alternatives for patients with small AAAs, protecting the patient from rupture or aneurysm-related death for at least 3 years. Copyright (c) 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.
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