CompletedInterventional

Arterial Revascularisation Trial - a randomised trial to compare survival following bilateral versus single internal mammary artery (IMA) grafting in coronary revascularisation

A heart bypass operation (CABG) uses healthy blood vessels to bypass blocked heart arteries. Usually, surgeons use a leg vein plus one artery from inside the chest wall. However, leg veins often become blocked after several years, whereas arteries tend to stay clear for much longer. This study compares two surgical methods: using just one chest artery (the current standard) versus using two chest arteries (one from each side of the chest wall). Researchers want to see if using two chest arteries improves long-term survival, reduces chest pain, and lowers the need for repeat heart procedures. Patients having planned bypass surgery are randomly assigned to receive either one or two chest artery grafts. The study team checks in with participants each year for 10 years, and again at 15 years, using questionnaires to monitor their recovery, general health, and quality of life.

At a glance

Status

Completed

Sponsor

University of Oxford (UK)

Enrolment target

3,000

Start

01 Jul 2004

Estimated completion

20 Dec 2007

Cardiovascular

What is this study about?

Coronary heart disease occurs when the blood vessels supplying the heart muscle become narrowed or blocked by fatty deposits. A common and effective treatment is coronary artery bypass graft (CABG) surgery. During this operation, surgeons take healthy blood vessels from other parts of the body and attach them to the heart, creating a new route for blood and oxygen to reach the heart muscle.

Traditionally, surgeons use an artery from inside the chest wall alongside veins taken from the leg. While this procedure works very well in the short and medium term, vein grafts tend to narrow or become blocked over time. About half of vein grafts clog within ten years, which can cause chest pain (angina) to return and may mean the patient needs another procedure. Chest arteries, on the other hand, are much tougher and generally stay open longer than veins.

This trial investigates whether using two chest arteries instead of one gives patients better long-term results. By following participants for up to 15 years after their operation, researchers hope to learn whether this approach helps people live longer, keeps them free of chest pain, and prevents the need for future heart surgery.

Key takeaways

The trial compares using two chest arteries against the standard one chest artery in heart bypass surgery.
Artery grafts typically stay open longer than vein grafts taken from the leg.
Patients are followed up through yearly health questionnaires for 10 years, and finally at 15 years.
Using two chest arteries takes slightly longer and carries a small additional risk of wound healing problems.
Participation is entirely voluntary and won't require extra hospital appointments.

Who may be eligible?

This study is designed for adults who have coronary heart disease affecting multiple blood vessels and who are already scheduled to have heart bypass surgery. This includes patients having planned surgery, urgent operations, or 'off-pump' surgery (where the heart continues beating during the operation).

You will not be able to take part if you only need a single bypass graft, or if you have already had heart bypass surgery in the past.

People who are currently having an active heart attack or who need surgery to repair or replace a heart valve at the same time as their bypass are also not eligible.

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.

You have been told you need coronary artery bypass graft (CABG) surgery.
You have blockages in more than one heart artery (multi-vessel disease).
You have not had heart bypass surgery before.
You do not require heart valve surgery at the same time.
You are not currently having an active or evolving heart attack.

Answer every question to see your result.

What does participation involve?

If you take part, your bypass surgery will proceed largely as normal, but you will be randomly assigned by a computer to have either one chest artery graft or two chest artery grafts. You cannot choose which group you are in, but both approaches are recognised surgical treatments.

The operation to use two chest arteries takes roughly 30 minutes longer than the standard procedure. After your surgery and hospital discharge, you will not need extra hospital visits just for the trial.

Instead, the research team will contact you once a year for the first 10 years, and once more at the 15-year mark. During these follow-ups, you will be asked to fill out simple health and quality-of-life questionnaires to let the team know how you are feeling and whether you have experienced any new heart problems.

Potential risks and benefits

Taking part may not give you personal health advantages, but using two chest arteries might lower your long-term risk of chest pain, heart attacks, or further heart operations. However, using two chest arteries can slightly increase the risk of chest wound healing problems from about 1 to 2 percent up to around 2 to 3 percent. This risk is highest for people who have diabetes, severe lung disease, or are very overweight. The operation also lasts around 30 minutes longer. Filling out yearly questionnaires may take up a small amount of your time. Your participation is completely voluntary, and you can change your mind and leave the study at any time without your regular NHS care being affected.

Locations (1)

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

Department of Cardiothoracic Surgery, The John Radcliffe
City only
Oxford, England

Common questions

What is an internal mammary artery?

It is a healthy blood vessel located inside your chest wall. Surgeons frequently use it for bypass surgery because it tends to stay clear of blockages much longer than leg veins.

Can I choose whether I get one or two chest arteries?

No. To ensure the trial results are fair and unbiased, a computer randomly decides which technique your surgeon will use.

Will taking part require lots of extra hospital visits?

No. Follow-ups are done using questionnaires that you can complete from home once a year for up to 10 years, and then once more at 15 years.

Does using two chest arteries make the surgery riskier?

It adds roughly 30 minutes to the operating time and slightly raises the risk of chest wound healing issues, but both methods are considered safe and standard surgical options.

What happens if I change my mind later on?

You are free to withdraw from the study at any time. Stepping down will never affect the standard of care or treatment you receive from the NHS.

How to find out more

Marcus Flather

M.Flather@uea.ac.uk - Official trial record

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