Every year, 60,000 people in the UK are diagnosed with heart failure, and many are treated with stents. It is in a great new study published in the New England Journal of Medicine that my colleagues and I have discovered that these procedures are unnecessary.
Heart failure is where the heart muscle weakens, leading to symptoms of severe shortness of breath that can lead to premature death. The most common cause is blockage of blood vessels that reduces blood supply to the heart muscle. This is called coronary artery disease.
A person with heart failure is treated with drugs and sometimes with specialized pacemakers. Despite this treatment, many patients die prematurely or are hospitalized with worsening symptoms.
People with heart failure also sometimes have a procedure to insert a stent — a small metal tube that is used to unblock a coronary artery. Stents are placed in the arteries of the heart by a cardiologist through tubes inserted either into the wrist or groin and guided by x-rays. Trials have shown that stents are a very effective treatment for people with heart attacks and anginabut their effects in patients with heart failure remained unclear.
Some cardiologists had noticed improvements in patients’ symptoms and heart function after stenting, but the researchers couldn’t say whether these improvements were directly related to the stents or if they would have happened anyway with medications. . Without proper research, treatment guidelines for the use of stents in patients with heart failure varied, with the The National Health Service (NHS) advises against stenting and European directives recommending it in some patients.
In this latest study, the REVIVED-BCIS2 trial, led by Professor Divaka Perera, we tested whether treatment with stents helped patients live longer or stay out of hospital. The trial was a collaboration of 40 NHS hospitals in the UK and ran from 2013 to 2020.
Patients could be included in the trial if they had severely weakened heart muscle and extensive coronary artery blockages. They also performed specialized heart scans, so that stenting could be targeted to areas of heart muscle most likely to recover.
A total of 700 patients participated in the study, and half of them were randomly selected to receive stents while all patients received standard treatment for heart failure. Patients attended follow-up appointments for up to eight years so that their heart health and function could be closely monitored.
An average of 3.4 years after treatment, patients who received stents were just as likely as those who did not die or were admitted to hospital with heart failure, showing that treatment is not was not effective.
Heart scans and blood tests also showed no difference in the pumping force of the heart, confirming the main results of the trial.
Our study showed that patients who had stents had a better quality of life in the first year, but after two years the difference disappeared and patients reported similar health. Although there was no benefit from inserting stents, there was also no evidence that the stents were causing harm.
No more research is needed
The trial results mean that the stents should not be used to treat patients with heart failure caused by coronary artery disease, unless they have another condition, such as angina or a recent heart attack.
The design and the number of patients involved in the trial mean that the answer is clear and further research to answer this question is not needed at this time. We’ll spend some time looking at the results to try to figure out why stenting isn’t working. Although no benefit has been shown, the results are important because they mean patients with heart failure will not undergo unnecessary procedures. The cost of stenting procedures can also be redirected to providing other treatments and better care for heart failure patients.