The Middlesbrough hospital’s Academic Cardiovascular Unit (ACU) has launched a National Institute for Health and Care Research (NIHR) funded study called the AFFECT trial.
Each year, thousands of people in the UK have surgery for mitral regurgitation – a common heart condition where the mitral valve fails to close tightly, allowing blood to leak backward into the left atrium instead of pumping forward to the body. This forces the heart to work harder, which can lead to fatigue, shortness of breath, and potential heart failure.
If these patients also have a heart rhythm issue they usually need blood-thinning medication to reduce their risk of having a stroke or other complications after surgery.
Current national and international guidelines recommend using a vitamin K antagonist (VKA) such as warfarin. But a newer group of medicines known as Direct Oral Anticoagulants (DOACs) are now also widely used.
The AFFECT trial aims to show which option offers the best long-term outcomes for patients.
About the study
The study is aiming to recruit 1,282 adults who are having mitral valve repair surgery at cardiothoracic centres across the UK.
Participants will be randomly allocated to receive either a Direct Oral Anticoagulant (DOAC) or a vitamin K antagonist (VKA).
Treatment will start before patients leave hospital. They will then be closely monitored for at least 12 months, with further annual check-ups for up to four years.
Researchers will assess a range of outcomes, including stroke prevention, quality of life and cost-effectiveness.
Eligible patients will be invited to take part by their clinical teams. More than 130 patients have already signed up and started treatment.
Improving long-term outcomes
Professor Enoch Akowuah, chief investigator for the AFFECT trial at University Hospitals Tees said: “This is an important question for both patients and clinicians.
“We know anticoagulation is essential for patients with atrial fibrillation after mitral valve repair, but we do not yet know which treatment offers the best balance of safety and protection.
“The AFFECT Trial will provide high-quality evidence to guide national treatment decisions and improve long-term outcomes for patients across the UK and internationally.”
For more details visit southtees.nhs.uk/about/strive/research-team/academic-cardiovascular-unit/acu-trials/the-affect-trial