The first patient in the UK to take part in a women-only cardiac surgery research trial underwent a life-changing heart operation at University Hospitals of Leicester NHS Trust recently.
Judith Knox, aged 76, was referred for coronary bypass surgery in 2023 after she was diagnosed with a diseased coronary artery.
After further investigations at Glenfield Hospital it was discovered that Judith wasn’t a suitable candidate for a stent (a small metal frame which can be inserted to keep the artery open) and would need to undergo a bypass.
Judith said: “I was invited for surgery and I was asked if I would like be part of the ROMA Women trial. They explained it all to me really well, about how what they discover in this trial could lead to changes in approach to bypass surgery for women in the future.
“I knew I was in safe hands with the team, and I thought ‘well how do we progress if people don’t take part?’, so I agreed.”
The ROMA Women trial, taking place within the National Institute for Heath and Care Research (NIHR) Leicester Biomedical Research Centre is investigating whether using multiple arteries for coronary artery bypass grafts (CABG) is better than using multiple veins (which are currently used) in women.
Heart surgery is technically more demanding in women, who tend to be older and have more long-term conditions when they present for surgery. As a consequence, women rarely receive multiple arterial bypass grafts although these are thought to result in better long-term outcomes.
Lead researcher, Professor Gavin Murphy who is a Consultant Cardiac Surgeon at University Hospitals NHS Trust and BHF Chair of Cardiac Surgery at the University of Leicester, explained: “This is the first ever randomised trial in cardiac surgery that will exclusively recruit women. Women are often underrepresented in cardiac surgery trials, and therefore the evidence that we use to guide treatment decisions in women is based on trials performed in men.
“We know that women have different patterns of coronary artery disease and are more likely to have other conditions when they present for surgery. For these reasons women are more likely to receive vein bypass grafts collected from the legs which do not last as long as arterial bypass grafts taken from the chest wall and the arm.
“This trial will show definitively which type of bypass graft results in better long-term outcomes, providing high quality evidence to plan the best operations for women.”
Judith Knox from Glenfield said: “Recovery has been very tiring and it’s been difficult to sleep, but I’m feeling better every day. I’m looking forward to the future, and to hearing more about what they discover in the trial. It feels good to be part of it.”
Judith will be monitored and seen between 2 and 12 weeks, and then at six month intervals for the next five years. Further follow-ups for up to 12 years will take place and her health and wellbeing reviewed.
Professor Gavin Murphy concluded: “We hope that the results of the ROMA Woman trial will tell us what bypass grafts should be used in women to deliver the best long-term outcomes following CABG surgery.”
For more details on the study, which is part of a trial taking place around the UK, please visit www.theromatrial.com