AAA Clinical Trial
Official title:
NHS AAA Screening Programme Data Linkage With HES and ONS Datasets
An abdominal aortic aneurysm (AAA) is a dilation of the aorta, defined as an aortic diameter
of ≥3cm. It is a significant cause of death internationally and in England each year causes
c.4,000 deaths with 8,000 patients undergoing preventative surgery. AAA are often
asymptomatic and there is a latent period between development and rupture. This represents an
opportunity to screen by ultrasound which has been shown in trials to reduce AAA related
mortality by half.
In England this evidence is based on a randomised trial data from the late nineties, however,
since these data were published the number of men identified with AAA has fallen to a current
prevalence of just over 1%. Furthermore, similarly designed randomised trials in Western
Australia demonstrated no meaningful differences in AAA or cardiovascular deaths. The first
aim of our research is to follow men who have been screened for AAA in England in order to
establish the medium (5 years) and long term (10+ years) impact of AAA screening on the risk
of a AAA, cardiovascular and all-cause morbidity/mortality in a non-trial setting. Men with
sub-aneurysms will be examined (Aorta=2.5-2.9cm) as several studies suggest this group is at
risk of late rupture.
The role of patient pathways to improve uptake of the screening programme will be examined.
Current data suggests that the most 'deprived' men in England are the least likely to turn up
for screening but the most likely to have an abdominal aneurysm. Outcomes in this group will
be analysed including the benefit of a new patient pathway to improve uptake nationally.
Lastly, several large studies have demonstrated that a larger aortic diameter may be
associated with cardiovascular risk. The addition of aortic diameter to current risk
prediction models could improve the accuracy of these models and will be examined.
An abdominal aortic aneurysm (AAA) is present in 5-10% of men aged between 65 and 79 years
and may be defined as an abdominal aortic diameter 3cm or above. In 2013 the NHS AAA
screening programme (NAAASP) was fully rolled out across England with the aim of reducing AAA
mortality in men aged 65 and over, based on evidence that screening reduces AAA-related
mortality, and is highly cost effective. Within NAAASP, men with a large AAA (≤5.5cm) are
referred for consideration of surgery whilst men with small AAA (≥5.4cm) are referred into
surveillance (3.0-4.4cm: 1 year surveillance, 4.5-5.4cm: 3 months surveillance) as per
standard operating procedures. In England 284,583 men were offered ultrasound screening
(2015-2016), however, the number of men identified with AAA was 2,549 at a cost of
approximately £7,755,000. This highlights one of the main problems with AAA screening in that
the majority of men screened do not have disease. This also brought the number of men within
AAA surveillance to 13,104 whom do not require early surgery.
The incidence of AAA is falling in western populations likely secondary to a reduction in the
number of individuals smoking cigarettes in addition to other pharmacological (increase in
the use of anti-platelets and statins) and lifestyle (exercise) modifications. This reduction
in the number of men with AAA raises the question of whether in the long term community AAA
screening will remain cost effective, however, to examine cost effectiveness it is important
to establish what happens to all men invited to AAA screening over time. One aspect of this
is examining the long term outcomes of men who have an aortic diameter above 3.0cm whilst
another highly debated topic is the outcome of men with an aortic diameter between 2.5-2.9cm
which may be defined as sub-aneurysmal. This group of men have been demonstrated to be at
risk of developing AAA in later life (over 10 years) and there is a risk that these
discharged men later go on to be at risk of aneurysm rupture.
the study would also like to examine the impact of deprivation on uptake of the screening
programme is England. Uptake of the screening programme in 2015-2016 was 85.4%, however this
varies from 76.6% in Merseyside to 92.0% in less deprived parts of England. Previous studies
have highlighted the association between social deprivation and poor uptake and pilot data
from our study suggests that this deprived group are also more likely to have an abdominal
aneurysm. This puts this group at great risk without the benefit of screening to prevent
rupture. Within this study outcomes in this group (AAA related death, admission and all-cause
mortality/morbidity) will be assessed in order to accurately assess the cost benefit of new
patient pathways to improve AAA screening uptake in the most deprived group.
Lastly, over time NAAASP will detect a large number of patients with small aneurysms that
will require regular surveillance. Patients with AAA are widely recognized to be at a higher
cardiovascular risk then the general population for example one recent systematic review
identified a strong link between cardiovascular death and time from diagnosis of small AAA
with a 3% increased risk of cardiovascular mortality per year compared with the general
population. Duncan and Colleagues also described long term outcomes of men screened for AAA
in Scotland finding that the most common cause of death in those with AAA was cardiovascular
disease and that this risk increases with aortic diameter. Increasing aortic diameter and
poor cardiovascular outcomes have also been noted in several other large cohort studies.
Aortic Diameter may be an independent marker of cardiovascular risk that could improve the
sensitivity of current cardiovascular risk prediction models used commonly in England.
Screening may also be an opportunity to identify men at higher cardiovascular risk (both with
an aneurysm and without) creating added benefit to the screening programme. None the less
contemporary data suggests that cardiovascular risk is inadequately addressed in this high
risk cohort and requires further study.
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