A landmark trial funded by our National Institute for Health and Care Research (NIHR) Biomedical Research Centre (BRC) and the British Heart Foundation Centre of Research Excellence at the School of Cardiovascular Medicine and Sciences, King’s College London, has clarified the role of coronary stents as a treatment for heart failure for patients with poor left ventricular function.
Coronary disease is the most common cause of heart failure worldwide and is responsible for 64,000 deaths in the UK each year. Coronary heart disease occurs when the coronary arteries become narrowed by build-up of fatty material within the artery wall which can lead to sudden heart attacks or, in some cases, gradually weaken the heart muscle.
While a treatment to widen the arteries with the insertion of a stent called percutaneous coronary intervention, (PCI), saves lives when used to treat patients at the time of an acute heart attack, the value of this treatment in patients with heart failure is uncertain. Despite this, many patients with heart failure currently undergo stent insertion if found to have coronary disease and this approach has been advocated by international guidelines.
REVIVED-BCIS2, led by clinical researchers from Guy’s and St Thomas’ NHS Foundation Trust and King’s College London is the first trial to examine the efficacy and safety of PCI in patients with very poor left ventricular function. It is the largest cohort of such patients to be recruited to a randomised controlled trial to date.
The study recruited 700 patients from 40 centres across the UK, with a fifth of all participants being patients at Guy’s and St Thomas’. All the patients in the trial received optimal medical therapy which included heart failure medication and, in many cases, special heart failure pacemakers/defibrillators. In addition, half of the patients were randomly assigned to receive PCI to all narrowed arteries that supplied part of heart muscle that were not irreversibly scarred.
The trial group followed-up these patients closely for up to 8.5 years. They found that carrying out PCI did not seem to reduce the risk of heart failure or death. 37.2% of patients assigned to PCI and 38% of patients assigned to optimal medical therapy were either hospitalised for heart failure or died during follow-up. The trial also found that more than one third of patients in both groups either died or had to be admitted to hospital with severe heart failure. This confirms that even with optimal medical therapy, these patients continue to have a poor outcome.
Additionally, the trial examined heart function by using echocardiography to assess a metric called left ventricular ejection fraction. Researchers found that there was some improvement in heart function over the first year in all patients, but the same degree of improvement was found in both groups. They also measured quality of life of participants and, although this was better in patients who underwent PCI in the first 6-12 months, there was no significant difference between the two groups after two years.
Chief Investigator, Divaka Perera, consultant cardiologist at Guy’s and St Thomas’ Professor of Interventional Cardiology at King’s College London, said:
“After years of practice based on anecdote and consensus opinion, we now have definitive evidence from the REVIVED trial that will help to rationalise management of this common condition. The results will probably lead to several changes in international guidelines and may also lead the scientific community to re-evaluate the concept of hibernation. This was the theory proposed decades ago to describe how the heart adapts to a chronic reduction in its own blood supply. The UK network of researchers has worked hard for nearly a decade and their efforts have been rewarded by providing a clear answer to this important question.”
For more information and to read the full results of the REVIVED-BCIS2 study, please visit The New England Journal of Medicine