is carotid stenosis?
stenosis is narrowing of the carotid artery, one of the major
blood supplies to the brain. The artery is narrowed by a build
up of cholesterol and other substances which form what is termed
an 'atherosclerotic plaque'. If part of this plaque breaks off
(emboli), it can travel along the artery and block off (occlude)
smaller blood vessels. This blockage means that the part of the
brain supplied by that blood vessel does not receive oxygen and
nutrients, and so cannot function, leading to a 'stroke'. If the
blood flow is not restored, the brain cells (neurons) will die.
stenosis is more common as people get older. It is also more common
in people who smoke, have high cholesterol, high blood pressure,
those with diabetics, and in the obese.
with carotid stenosis may have no symptoms ('asymptomatic'), or
may have symptoms due to stenosis ('symptomatic'). Symptomatic
patients may have had a stroke, or may have had a TIA - transient
ischaemic attack - or 'mini-stroke'. Symptoms include limb or
face weakness, difficulties speaking or swallowing, difficulties
with vision, loss of sensation, or personality changes. These
changes may be permenant, or may improve with time.
is the ECST-2 trial?
of the treatment options for carotid stenosis is 'endarcterectomy'.
This is a surgical procedure in which a surgeon cuts open the
artery, and removes the atherosclerotic plaque (revascularisation).
This is an effective procedure at reducing the stenosis, but risks
of the procedure include bleeding into the neck, nerve damage,
and stroke. In patients where the carotid artery has moderate
or severe stenosis, previous clinical trials have shown that the
benefits of surgery outweigh the risks. However, some trials have
also shown that only patients with a high risk of stroke benefit
from the surgery. Since these trials were conducted, new medications
have meant that the medical (i.e. taking medications) management
of risk factors such as blood pressure and cholesterol is much
better than it used to be.
aim of the ECST-2 trial is to see whether patients who have a
low or intermediate risk of stroke (where the role of carotid
surgery is not clearly established) are best treated with surgery,
or with medications alone.
does the trial work?
you choose to participate in the trial, you will be randomly assigned
to either the:
- medical management group (optimised modern medical therapy -
- surgery with medication (OMT) group
you have entered the trial you will be seen by a clinician within
48 hours. Your next appointment will depend on which group you
are in: if you are in the surgery group you will be seen 30 days
after your procedure; if you are in the medical management group
you will be see 6 weeks after you enter the trial. Participants
in both groups will then have an appointment 6 months after entering
the trial, and then annually after entering the trial for 5-10
part in the study is voluntary, and if you choose not to enter
the trial, or choose to leave the trial at any time, the quality
of your medical care will not be affected. All of the information
that is collected will be strictly confidential, and kept on secure