During up to 4 years of follow-up in trial 2, there was no statistically significant difference between the two study groups in total mortality or in aneurysm-related mortality (Lancet 2005; 365:2187–92).
The performance of EVAR in trial 2 was handicapped by two factors, Dr. Cronenwett said in an editorial. First was the lag between randomization and EVAR—a delay that probably led to the ruptures in nine patients. Second was the high rate of aneurysm repairs in the patients randomized to medical management. These two factors “bias the study against EVAR,” he wrote (Lancet 2005;365:2156–8).
Nonetheless, trial 2 shows that in patients with a relatively short life expectancy, EVAR should be targeted to carefully selected patients, he said.
Trial 1 also shows that patients with low operative risk are the best candidates for open repair and should be considered for EVAR only if they have excellent anatomic suitability. According to Dr. Riles, that would mean a long, proximal, aortic neck, 1.5 cm or longer, and a width that's ideally no more than 28 mm.
A relatively small fraction of patients with marginal anatomic suitability and a short life expectancy are best managed medically with no aneurysm repair. But a sizable fraction of patients fall into a gray area, where there is no clear advantage of EVAR or open repair. In these cases, patient preference is an important factor, Dr. Cronenwett wrote.
Dr. Riles noted that the data from the British trials will be useful for tempering the enthusiasm of some patients for EVAR by showing them that after EVAR, they face an ongoing risk that a follow-up procedure will be needed in the future.