CompletedInterventional

European Carotid Surgery Trial 2

The carotid arteries in your neck supply blood to your brain. Over time, fatty deposits can narrow these arteries, which raises the risk of a stroke. In the past, having an operation or stent to clear the artery was standard. However, modern medications for blood pressure and cholesterol have improved dramatically. The European Carotid Surgery Trial 2 (ECST-2) investigates whether people at lower risk of stroke still benefit from an operation or stent, or if taking optimised medications alone is now just as safe and effective. Participants are randomly placed into one of two groups: one receives top-quality medication and lifestyle guidance alone, while the other receives this same medical care plus a procedure to widen the artery. Everyone is followed up regularly for several years to track their health and stroke risk.

At a glance

Status

Completed

Sponsor

University College London (UK)

Enrolment target

200

Start

23 Mar 2012

Estimated completion

31 Oct 2019

Stroke

What is this study about?

Carotid artery narrowing happens when fatty materials build up inside the main blood vessels in the neck. If a piece of this build-up breaks off, it can travel to the brain and cause a stroke. For many years, doctors commonly offered surgery (carotid endarterectomy) or a wire-mesh tube (a stent) to clear the blockage and lower this risk.

Since those treatments were first developed, daily medications have improved enormously. Today's medicines do a much better job of lowering cholesterol, keeping blood pressure steady, and thinning the blood to prevent clots. For people who have a lower risk of stroke—such as those who have not had recent warning symptoms—it is no longer clear whether the benefits of an operation outweigh the risks of surgery.

This trial aims to answer that question. It helps doctors understand if carefully managed medication alone can protect patients just as well as an operation, sparing many people from undergoing unnecessary procedures in the future.

Key takeaways

Tests whether modern tablets alone are as effective as surgery for narrowed neck arteries.
Aimed at adults with at least 50% carotid narrowing who are at lower risk of stroke.
Participants are randomly chosen to have a procedure plus tablets, or tablets alone.
All participants receive closely monitored blood pressure and cholesterol care.
The findings will help shape future guidelines for stroke prevention across the UK.

Who may be eligible?

This trial is for adults aged 18 and older who have a narrowing of at least 50% in one of their main neck arteries, caused by fatty build-up. It focuses on people whose overall risk of having a stroke in the next five years is estimated to be low to moderate (under 20%), and whose doctor is not sure whether an operation is truly necessary.

You cannot take part if you have had severe disability from a past stroke, if your symptoms are currently getting worse, or if your artery narrowing was caused by something other than fatty build-up (such as radiation treatment). You will also not be able to join if you are pregnant, need another major operation within a month, or have a life-limiting illness of less than two years.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have been told I have a narrowed neck (carotid) artery of at least 50%.
My doctor considers my overall risk of stroke in the next 5 years to be low or moderate.
I am in a stable condition and not currently getting new or worsening nerve symptoms.
I am able and willing to attend regular follow-up hospital visits for several years.

Answer every question to see your result.

What does participation involve?

If you join the trial, your doctors will first review your medicines and adjust them to achieve the best possible blood pressure and cholesterol levels. You will also receive helpful advice on healthy lifestyle choices. You will then be randomly assigned by a computer to one of two groups: one group has surgery or a stent right away alongside their medicines, while the other group takes medicines alone.

You will attend regular clinic visits over several years. During these appointments, the medical team will monitor your blood pressure and cholesterol, check your overall health, and ask about any new symptoms. Total participation lasts for several years to ensure long-term safety.

Potential risks and benefits

All participants benefit from having their medications and cardiovascular health closely monitored by specialists. However, medical procedures carry risks. Surgery or stenting involves a small chance of causing a stroke, heart attack, or temporary facial weakness, with serious complications occurring in about 3 to 6 out of every 100 procedures. Those who take medication alone avoid procedural risks, but there remains an ongoing chance of having a stroke. Taking part is completely voluntary, and you are free to leave the study at any time without your regular NHS care being affected.

Locations (31)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

National Hospital for Neurology and Neurosurgery
Unverified
London, England
University College London Hospital
Unverified
London, England
Sheffield Teaching Hospitals NHS Foundation Trust
Unverified
Sheffield, England
Nottingham University Hospitals NHS Trust - City Campus
Unverified
Nottingham, England
Leeds General Infirmary
Unverified
Leeds, England
Calderdale and Huddersfield NHS Foundation Trust
Unverified
Huddersfield, England
Frimley Park Hospital
Unverified
Camberley, England
East Kent Hospitals University NHS Foundation Trust
Unverified
Canterbury, England
Royal Devon and Exeter Hospital
Unverified
Exeter, England
St George's Hospital
Unverified
London, England
Manchester Royal Infirmary
Unverified
Manchester, England
NHS Ayrshire and Arran
Unverified
Ayr, Scotland

Common questions

What is the difference between surgery and a stent?

Surgery involves a small cut in the neck to open the artery and remove the fatty plaque. A stent is a tiny mesh tube guided into the neck artery through a small puncture in the groin to hold the blood vessel open.

Can I choose which treatment group I join?

No. A computer randomly selects your group to ensure the study results are fair and unbiased. Both options are considered reasonable medical choices for your situation.

What happens if my condition gets worse while taking tablets alone?

Your health is monitored closely. If your doctor feels that surgery or stenting becomes clearly necessary at any point, you can have the procedure immediately.

Will taking part cost me anything?

No. The medical care, study assessments, and trial treatments are provided free of charge through the hospital and research teams.

What if I decide I want to stop taking part?

You can withdraw from the study at any stage. Your doctors will continue to give you the best standard medical care regardless of your decision.

How to find out more

Martin Brown

martin.brown@ucl.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.