Does EVAR alter the rate of cardiovascular events in patients with abdominal aortic aneurysm considered unfit for open repair? Results from the randomised EVAR trial 2.
OBJECTIVE
To investigate whether endovascular aneurysm repair (EVAR) influences the rate of cardiovascular events (fatal or non-fatal myocardial infarction or stroke) in patients with abdominal aortic aneurysm (AAA) considered unfit for open repair.


METHODS
Randomised controlled trial.


METHODS
Between 1999 and 2004, 404 patients with large AAA considered unfit for open repair were randomised to EVAR or no surgical intervention across 33 UK hospitals and followed until July 2009.


METHODS
The Customised Probability Index was used to determine fitness for each patient and Cox regression was used to compare time to first cardiovascular event between randomised groups and levels of fitness.


RESULTS
During an average of 2.8 years of follow-up, 67 first cardiovascular events occurred with a non-significantly higher event rate in the EVAR group compared to the no intervention group (6.6 versus 5.1 events per 100 person years); adjusted hazard ratio 1.42 [95% CI 0.87-2.34], p=0.156. There was no evidence to suggest that the hazard ratio between randomised groups changed with level of fitness (p=0.378).


CONCLUSIONS
Cardiovascular event rates were high in these unfit patients and medical therapy was sub-optimal. Events rates were slightly higher in the EVAR group but this was not statistically significant.
Brown
L C
LC
Vascular Surgery Research Group, Imperial College, 4th Floor, Charing Cross Hospital, Fulham Palace Road, London, UK. louise.brown@imperial.ac.uk
Greenhalgh
R M
RM
Thompson
S G
SG
Powell
J T
JT
D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001027:Aortography / Q000379:methods; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects* / Q000401:mortality; D016009:Chi-Square Distribution; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D009203:Myocardial Infarction / Q000209:etiology* / Q000401:mortality; D018579:Patient Selection; D016016:Proportional Hazards Models; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D020521:Stroke / Q000209:etiology* / Q000401:mortality; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D006113:United Kingdom