Key Evidence for EVAR

Question 1

What is the Key trial providing evidence for EVAR use?

Answer 1

The EVAR Trial

Question 2

EVAR Methods:

Answer 2

Males >60 years old.
Aneurysms >5.5cm
Split into two arms:
1. Patients fit for open AND EVAR = EVAR 1 trial
2. Patients unfit for open but fit for EVAR = EVAR 2 trial

Question 3

EVAR 1 Outcomes:

Answer 3

30-day mortality post-operatively was significantly BETTER in the EVAR group than the open group.
6 month results between the two groups were similar.
EVAR required more secondary intervention
EVAR was significantly more expensive
*a similar trial, DREAM, showed improved QoL with EVAR but this wasn’t evaluated in EVAR 1

Question 4

EVAR 2 Outcomes:

Answer 4

30 day mortality in the EVAR group in EVAR 2 was much HIGHER than mortality in EVAR 1 (because EVAR was performed on patients who were less fit)
EVAR patients had significantly lower AAA-mortality compared to those who received no intervention, but all cause mortality was the same between the two groups (patients still died, they just died of something else)
EVAR was much more expensive than no-interention, and required secondary interventions
*The high 30-day mortality shows that even though EVAR was developed for higher risk patients, it is still not very safe in those considered high risk.

Question 5

Results of EVAR 1 Follow Up (8 years):

Answer 5

In the long term, open repair had LOWER mortality than EVAR
EVAR mortality increased because of secondary aneurysm rupture (due to aneurysm leak) and increased cancer risk (x-rays used in angiography)

Question 6

Results of EVAR 2 Follow Up (8 years):

Answer 6

No major change in all-cause mortality between groups, but EVAR had lower AAA-mortality.
No change in QoL between groups
EVAR showed increased pain on the SF-36 scale

Question 7

EVAR and Clinical Practice:

Answer 7

Can only be used in ‘type 4’ anuerysms-limited to the abdominal aorta below the diaphragm
Interventional procedure guidelines published 2006 based on a systematic review:
70 studies including EVAR 1 and 2, 17 non-RCTs and 22 observational studies
Safety aspects were taken from a Meta analysis which showed:
EVAR is shown to have a lower 30-day mortality than open repair
Most common side effect is endoleak: 19%
Haemorrhagic complications are lower in EVAR than open