The United Kingdom EVAR Trial Investigators. Endovascular versus open repair of abdominal aortic aneurysm. N Engl J Med 2010; 362: 1863-71
In a nutshell
This paper presents the findings of the EVAR 1 trial which was a randomised controlled trial comparing endovascular aneurysm repair (EVAR) to open abdominal aortic aneurysm repair in patients considered fit for both procedures.
In total, 1252 patients were recruited to this multicentre, prospective study. The primary outcome measure was all cause mortality. Aneurysm-related deaths, graft-related complications and graft-related interventions were also assessed. There were no significant differences between the two groups at baseline. The median follow-up until death or the end of the study was six years (minimum five years, maximum 10 years).
The 30-day operative mortality rate was 1.8% in the endovascular group and 4.3% in the open repair groups (95% CI 0.18 – 0.87;
p=0.02). This early benefit with respect to aneurysm-related mortality in the EVAR group however was lost by the end of the study, at least partially because of fatal endograft ruptures (adjusted HR with EVAR 0.92; 95% CI 0.57-1.49).
There was no significant difference between the two groups in all cause mortality or aneurysmrelated mortality by the end of eight years of follow-up. EVAR patients however were at significantly higher risk of graft complication (adjusted HR 4.39; 95% CI 3.38-5.7; p<0.001) and graft-related intervention (adjusted HR 2.86; 95% CI 2.08-3.94; p<0.001). The highest risk for graft-related complication and intervention occurred between six months and four years after randomisation. Over eight years of follow-up EVAR cost £3,019 more than open repair.
Second opinion
This is a large well-designed, randomised trial with a long follow-up period (median six years). There were very few treatment crossovers and hardly any patients were lost to follow-up with almost complete data gathered.
The initial benefit for EVAR reported in the early years after repair were completely lost in the subsequent years. The main reason for this was the secondary ruptures which occurred only in the EVAR group. There were no secondary ruptures in patients treated with open repair. The findings of this study suggest that there is no long-term advantage for EVAR, that reintervention rates amongst EVAR patients are many times higher than in the open group and remain considerable even beyond four years after the
intervention and that EVAR is costlier.
At face value these findings raise serious doubts about the justification for EVAR. However, the endografts used in the trial were second and third generation. These have mostly been replaced by newer devices which would be expected to be more durable although evidence to support this is still poor or lacking.
The verdict
- EVAR is associated with significantly lower 30-day operative mortality than open repair
- In the long-term there is no difference in mortality between open repair and EVAR
- Graft-related complications and interventions are far commoner after EVAR.
Kurstein Sant
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Kevin Cassar
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