Background Endovascular aneurysm repair (EVAR) is a new technology to treat pa tients with abdominal aortic aneurysm (AAA) when the anatomy is suitable. Uncert ainty exists about how endovascular repair compares with conventional open surge ry. EVAR trial 1 was instigated to compare these treatments in patients judged f it for open AAA repair. Methods Between 1999 and 2003,1082 elective (non emerge ncy) patients were randomised to receive either EVAR (n=543) or open AAA repair (n=539). Patients aged at least 60 years with aneurysms of diameter 5.5 cm or mo re, who were fit enough for open surgical repair (anaesthetically and medically well enough for the procedure), were recruited for the study at 41 British hospi tals proficient in the EVAR technique. The primary outcome measure is all cause mortality and these results will be released in 2005. The primary analysis pres ented here is operative mortality by intention to treat and a secondary analysis was done in per protocol patients. Findings Patients (983 men, 99 women) had a mean age of 74 years (SD 6) and mean AAA diameter of 6.5 cm (SD 1). 1047 (97%) patients underwent AAA repair and 1008 (93%) received their allocated treatmen t. 30-day mortality in the EVAR group was 1.7%(9/531) versus 4.7%(24/516) in the open repair group (odds ratio 0.35 [95%CI 0.16-0.77], p=0.009). By per p rotocol analysis, 30-day mortality for EVAR was 1.6%(8/512) versus 4.6%(23/49 6) for open repair (0.33 [0.15-0.74], p=0.007). Secondary interventions were mo re common in patients allocated EVAR (9.8%vs 5.8%, p=0.02). Interpretation In patients with large AAAs, treatment by EVAR reduced the 30-day operative mortal ity by two thirds compared with open repair. Any change in clinical practice sh ould await durability and longer term results.
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