RecruitingInterventional

Drug-coated balloon (Sequent Please Neo) vs drug-eluting stent treatment for acute ST-elevation myocardial infarction: a randomised trial

If you have a serious type of heart attack called a STEMI, doctors quickly open blocked heart arteries. This study compares two main ways to keep that artery open long-term: using a drug-coated balloon or fitting a drug-eluting stent. Stents have been used for years, but sometimes they can narrow again. The balloon coats the artery with medicine, then is removed, so no permanent device stays inside. Doctors want to know if the balloon method, which avoids leaving a device, works as well as, or better than, a stent. The study will look at things like heart attacks, further treatments, and cardiac death over several years. Both treatments are already approved for use in the UK.

At a glance

Status

Recruiting

Sponsor

University Hospitals Sussex NHS Foundation Trust

Enrolment target

700

Start

13 Oct 2025

Estimated completion

01 Oct 2027

Acute ST-elevation myocardial infarction

What is this study about?

When someone has a serious heart attack, known as a STEMI, it means one of the main arteries supplying blood to their heart has become completely blocked. Getting treatment quickly to unblock this artery is very important and can save lives. Doctors usually do this by inserting a thin tube (catheter) into the wrist, guiding it to the heart, and then using a tiny balloon to open up the blockage.

Once the artery is open, the next step is to try and keep it from closing again. Traditionally, a small mesh tube called a drug-eluting stent (DES) is placed inside the artery to hold it open and release medicine. Stents work well for many years, but sometimes the artery can narrow again over time. Recently, another treatment has become available: a drug-coated balloon (DCB). This balloon also releases medicine into the artery to stop it from narrowing, but once the medicine is delivered, the balloon is removed, leaving no permanent device inside the artery.

This study aims to compare these two options directly: the drug-coated balloon versus the drug-eluting stent. Doctors want to find out if the drug-coated balloon treatment, which doesn't leave a permanent implant in the artery, is just as safe and effective as the stent treatment. They will be looking at how well patients do 1, 3, 5, and 8 years after treatment, checking for things like another heart attack, needing more treatment on the same artery, or cardiac death. All the devices used in this study are already approved for use in the UK.

Key takeaways

Compares two standard heart attack treatments: drug-coated balloon vs. drug-eluting stent.
Aims to see if the balloon, which leaves no device, is as effective as a stent.
No extra research risks beyond usual care, as both treatments are approved.
Long-term follow-up for 8 years to track heart health.
You will know which treatment you receive.
Funded by B. Braun Melsungen AG and run from University Hospital Sussex NHS.

Who may be eligible?

This study is looking for people who have just had a specific type of heart attack called a STEMI. This means your heart attack symptoms must have lasted for at least 30 minutes, and special heart scans (ECG) must show certain changes that confirm a STEMI.

If you've had a STEMI that needs immediate treatment to open up your heart artery, you might be able to join. The doctors will also check other things to make sure the study is right for you, like if you've previously had a major heart bypass surgery. If you have, you won't be able to join this particular study.

The study is also not suitable for people who have had significant bleeding recently, or if you are allergic to certain common heart medications like aspirin or specific blood thinners. If you have any questions about whether you might be suitable, it's always best to speak to your doctor or the study team.

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.

Have I recently had a heart attack (STEMI) needing urgent treatment to unblock an artery?
Did my heart attack symptoms last for at least 30 minutes?
Do my ECG results confirm a STEMI based on specific changes?
Have I ever had major heart bypass surgery before?
Am I allergic to aspirin or common blood-thinning medications?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to receive one of two established treatments for your heart attack: either a drug-coated balloon or a drug-eluting stent. This decision is made by chance, like flipping a coin, so it's fair. Both treatments are standard practice.

Before, during, and after your heart procedure, you'll receive all the usual medications and care according to hospital guidelines. Your stay in the hospital won't change because of the study. After your procedure, you'll be given detailed written information about the study, and your consent to continue in the study will be asked before you leave the hospital, usually within a day.

After you go home, you’ll have regular check-ups at the hospital, just as you normally would. Additionally, the study team will follow up with you by phone at 30 days, 1 year, 3 years, 5 years, and 8 years. During these calls, they will ask about your health, any medications you're taking, and if you've experienced any other heart problems. You'll also answer a short questionnaire about any chest pain you might have. Your medical notes will also be reviewed by the study team, if needed, to track your progress over time.

Potential risks and benefits

Both the drug-coated balloon and the drug-eluting stent are approved treatments already used in the UK, so there are no extra risks from the research itself. A potential benefit of the drug-coated balloon treatment is that it doesn't leave a permanent device inside your artery. This might reduce the chance of the artery narrowing again much later, and it could also mean you might not need to take blood-thinning medicines for as long, potentially lowering your risk of bleeding. If you ever needed bypass surgery in the future, it might also be easier to treat the artery that received a balloon compared to one with a stent. However, it's important to remember that these potential benefits are what the study is trying to confirm. You are free to withdraw from the study at any time without affecting your medical care.

Locations (14)

University Hospitals Sussex NHS Foundation Trust
City only
Worthing, England
Norfolk and Norwich University Hospitals NHS Foundation Trust
City only
Norwich, England
University Hospitals Dorset NHS Foundation Trust
City only
Poole, England
Worcestershire Acute Hospitals NHS Trust
Approximate
Worcester, England
St George's Healthcare Nhst
City only
London, England
Sheffield Teaching Hospitals NHS Foundation Trust
City only
Sheffield, England
University Hospitals of North Midlands NHS Trust
City only
Stoke-on-trent, England
University Hospitals Birmingham NHS Foundation Trust
City only
Birmingham, England
Cardiff & Vale University Lhb
City only
Cardiff, Wales
St. Bartholomews Hospital
City only
London, England
Portsmouth Hospitals University NHS Trust
Unverified
Portsmouth, England
University Hospitals of Derby and Burton NHS Foundation Trust
Unverified
Derby, England

Common questions

What is a STEMI?

A STEMI is a serious type of heart attack where one of the main arteries to your heart is completely blocked, needing urgent treatment.

What is a drug-coated balloon (DCB)?

It's a special balloon that delivers medicine to your heart artery to keep it from re-narrowing. The balloon is then removed, leaving no permanent device.

What is a drug-eluting stent (DES)?

It's a tiny mesh tube that is left in your heart artery to hold it open and release medicine, preventing it from closing up again.

Will I know which treatment I receive?

Yes, this is an 'open-label' study, meaning both you and your doctors will know whether you received the drug-coated balloon or the drug-eluting stent.

How long will the study follow me?

The study will follow your health for a long time, with check-ins by phone at 30 days, 1 year, 3 years, 5 years, and 8 years after your treatment.

How to find out more

Scott Harfield

scott.harfield@nhs.net +44 (0)127 369 6955 Official trial record

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