What is carotid stenosis?

Carotid 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.

Carotid 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.

People 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.

What is the ECST-2 trial?

One 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.

The 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.

How does the trial work?

If you choose to participate in the trial, you will be randomly assigned to either the:
- medical management group (optimised modern medical therapy - OMT)
- surgery with medication (OMT) group

After 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 years.

Taking 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 databases.