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 King’s and Guy’s and St Thomas’ NHS Foundation Trust and supported by the National Institute for Health and Care research (NIHR) Guy’s and St Thomas’ Biomedical Research Centre (BRC), 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. Results of this trial are published today in the New England Journal of Medicine and simultaneously presented at the European Society of Cardiology Congress in Barcelona, Spain.
REVIVED-BCIS2 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.
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.– Chief Investigator, Divaka Perera, Professor on Interventional Cardiology at King’s and consultant cardiologist at Guy’s and St Thomas’
Professor James Leiper, Associate Medical Director at the British Heart Foundation, said: “Heart failure is a chronic condition that worsens over time, with treatments aimed at improving symptoms and the patient’s quality of life. Many heart failure patients will have received coronary stents as a part of their treatment to stop the progression of coronary heart disease. However, this study shows the use of stents as treatment does not improve heart function or outcome in patients with heart failure.
“More research will be required to understand the applicability of these results to the wide range of patients with heart conditions that undergo PCI. However, this important study could potentially be added to the current evidence base to update guidelines for management of heart failure patients.”