Comparison of surveillance vs Aortic Endografting for Small Aneurysm Repair (CAESAR) trial: study design and progress.
OBJECTIVE
The CAESAR Trial aims to assess the outcome of endovascular repair (EVAR) vs surveillance of small abdominal aortic aneurysms (AAA) with maximum diameter of 4.1-5.4 cm on computerised tomography (CT) scan.


METHODS
Patients between 50 and 80 years of age, with small AAA, anatomically suitable for EVAR, are randomly allocated to early EVAR or surveillance. The primary outcome measure is survival. Secondary endpoints include: aneurysm-related deaths (defined as any death caused directly or indirectly by rupture or endovascular/open aneurysm repair), AAA rupture, peri-operative or late complications, conversion to open repair, complications associated with delayed treatment including loss of treatment options, AAA growth rates and quality of life. Target recruitment is 740 patients to show that early EVAR is associated with a 15% survival benefit at 54 months.


RESULTS
Randomization started in September 2004. By the end of April 2005, 86 patients had been enrolled by 10 active European centres. Completion of recruitment is expected for September 2006 and publication of the results in mid 2007.
Cao
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U.O. di Chirurgia Vascolare, Policlinico Monteluce, Via Brunamonti, I-06122 Perugia, Italy. pcao@unipg.it
D000368:Aged; D001011:Aorta / Q000473:pathology*; D017544:Aortic Aneurysm, Abdominal / Q000150:complications / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D001019:Aortic Rupture / Q000209:etiology / Q000401:mortality*; D019917:Blood Vessel Prosthesis Implantation; D006801:Humans; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009929:Organ Size; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D016019:Survival Analysis; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome