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 emerg ency) 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 m ore, who were fit enough for open surgical repair (anaesthetically and medically well enough for the procedure), were recruited for the study at 41 British hosp itals proficient in the EVAR technique. The primary outcome measure is all cause mortality and these results will be rele ased in 2005. The primary analysis presented here is operative mortality by inte ntion to treat and a secondary analysis was done in per protocol patients. Find ings 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 treatment. 30-day mortality in the EVAR group wa s 1.7%(9/531)versus 4.7%(24/516) in the open repair group (odds ratio 0.35>, p=0.009). By per protocol analysis, 30-day mortality for EVA R was 1.6%(8/512) versus 4.6%(23/496) for open repair (0.33 >, p=0. 007). Secondary interventions were more 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 mortality by two thirds compared with open repai r. Any change in clinical practice should await durability and longer term resul ts.
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