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Design of the abdominal aortic Aneurysm Detection and Management Study. ADAM VA Cooperative Study Group
F A Lederle1, S E Wilson, G R Johnson
1Department of Medicine, Veterans Affairs Medical Center, Minneapolis, MN 55417.
Purpose:
This study describes the design of an ongoing randomized trial intended to determine which of two strategies is superior for managing small abdominal aortic aneurysms (AAA).
Methods:
Patients aged 50 to 79 years with AAA 4.0 to 5.4 cm in diameter as determined by computed tomography (CT) who are not at high surgical risk are randomized to either repair of the AAA, called "immediate surgery," or follow-up of the AAA with ultrasonography or CT every 6 months, reserving surgery for those aneurysms that enlarge to 5.5 cm, enlarge rapidly, or become symptomatic, called "selective surgery."
Results:
The primary outcome measure is all-cause death, and secondary outcome measures are AAA-related death, morbidity, and general health status. The study design calls for 1350 patients to be randomized and monitored for a mean of 5 years. A second objective of the study is to accurately define the prevalence and risk factors for AAA with use of information from the large screening program established to detect AAA for recruitment into the randomized trial.
Conclusions:
By the end of 1993, 38,697 patients had been screened with ultrasonography, accounting for about three fourths of new randomizations, and 330 patients had been enrolled (70% of the target rate).
Insights
This randomized trial compares immediate surgery versus selective surgery for small abdominal aortic aneurysms (AAA). The study aims to determine the superior management strategy for AAA to reduce mortality.
Area of Science:
- Vascular Surgery
- Clinical Trials
- Aortic Aneurysm Management
Background:
- Small abdominal aortic aneurysms (AAA) require careful management strategies.
- Current guidelines suggest monitoring or early intervention for AAA.
- Optimal timing for intervention in small AAA remains under investigation.
Purpose of the Study:
- To compare the efficacy of immediate surgical repair versus selective surgical repair for small abdominal aortic aneurysms (AAA).
- To evaluate all-cause mortality, AAA-related death, morbidity, and general health status as primary and secondary outcomes.
- To define the prevalence and risk factors of AAA through a large-scale screening program.
Main Methods:
- Randomized trial design involving patients aged 50-79 years with AAA (4.0-5.4 cm diameter).
- Two randomization arms: immediate AAA repair versus selective repair based on growth or symptoms.
- Primary outcome: all-cause death; secondary outcomes: AAA-related death, morbidity, health status.
Main Results:
- The study enrolled 330 patients by the end of 1993, achieving 70% of the target rate.
- Ultrasonography screening identified 38,697 patients, contributing significantly to recruitment.
- The trial is designed to randomize 1350 patients for a mean follow-up of 5 years.
Conclusions:
- The trial design facilitates comparison of two distinct management strategies for small abdominal aortic aneurysms.
- The ongoing screening program provides valuable data on AAA prevalence and risk factors.
- Further results are anticipated to guide clinical decision-making for small AAA management.