Welcome to my last heart research blog of the year! As is commonplace for this time of year, I thought a good way to round things off would be to highlight the most interesting research papers I have come across in 2023, and add a few key ‘take home’ messages. We are lucky in cardiology that we can draw on such a wealth of data, with a huge numbers of researchers worldwide contributing to the pool. Cardiology is one of the increasingly few specialties in medicine in the UK where trainees are encouraged to take time out for 2-3 years to do a formal research degree. Clearly research isn’t for everyone, but in a system where doctors are often encouraged to finish their training as fast as possible, it’s encouraging to think many Cardiologists are developing an early interest in research that will continue to benefit their patients for years to come. My own research years were a difficult time, mainly due to dealing with unforeseen problems with the study, but reflecting back over a decade later and those were important life skills learnt!
So here are my top trials of the year:
Semaglutide – SELECT trial
Hot off the press! You may well have heard of this drug, as it has been touted as a weight loss wonder drug. I have written often about the obesity problem the world faces; could this group of drugs present a ray of sunlight?
We already know that this drug reduces cardiovascular outcomes in high risk patients with diabetes, but just a few weeks ago the New England Journal of Medicine (one of the highest ranked medical journals in the world) published the SELECT trial. This trial randomised around 8000 overweight or obese patients with cardiovascular disease but NO diabetes to once weekly semaglutide or placebo for nearly 3 years, with another 3 years of follow-up. 6.5% of the semaglutide group and 8% of the placebo group experienced one of a composite of death / non-fatal heart attack / non-fatal stroke. This represented a 20% reduction, which was statistically significant. Nearly 16% of patients had to stop the drug due to side effects. Suddenly we have a diabetes drug which helps non-diabetics with cardiovascular disease. It will be very interesting to see how this gets licensed in the UK by NICE as a result of this.
NOAH AF-net and ARTESIA trials
We know strokes as a result of atrial fibrillation can be devastating, and much resource has gone in to detection and prevention of this with blood thinners known as DOACs (edoxaban, apixaban, rivaroxaban, dabigatran). AF can come and go (paroxysmal AF) or be persistent, or permanent. One area often debated in my world is if AF comes and goes, how much do you need to have to warrant a blood thinner? One hour? One day? Longer? This is particularly tricky as not all patients with AF have any symptoms.
Patients with devices such as pacemakers give us an opportunity to detect AF in patients without symptoms and try and get some answers. These two trials had their differences, and were fairly complex so I think best to just give you the summary:
In patients with device detected atrial arrhythmias at risk of a stroke, the DOAC drugs used did indeed reduce the risk of stroke or an embolism elsewhere in the arterial system, but at the cost of a large increase in significant bleeding. If the stroke risk was high, you might well think this was a trade off worth having. However that was not the case, with <1% stroke rate per patient-year. This speaks to the need for careful doctor-patient discussion highlighting risks and benefits in each individual case.
ORBITA-2
Drug trials are (relatively!) simple to construct a placebo control for. Of course the treatment tablet may have side effects, so patients are more likely to know they are on treatment not a placebo, but at least researchers can make the drugs look the same…
Not so in the world of interventional procedures. I have written some years ago about the ORBITA-1 trial, which uniquely used a sham stent procedure – patients were ‘blinded’ to whether a stent went in their heart or not – ie they went through the whole operation in the catheter lab without knowing if they had actually had the procedure! That trial cast doubt on the benefit of stents by showing that they had no additional benefit with respect to the length of time a patient can exercise over and above good tablet treatment in patients with severe coronary disease. As you might imagine, that caused quite a stir!
Orbita-2 used the same sham procedure technique, but this time the patient population stopped their anti-anginal medication before the procedure. The authors used an app to assess symptoms, and this time the results favoured stents. However the magnitude of effect was still fairly small in my view (an extra 1 minute on a treadmill, and nearly 2 thirds of patients still experienced symptoms afterwards regardless). The follow up was also short at only a few months. However, in patients prepared to undergo an interventional procedure for stable symptoms, there is at least now some evidence. It remains to be seen how this will be incorporated into national guidance. Again, this speaks to the need for careful discussion between patient and Cardiologist about the nuances in their particular case.
I hope you have enjoyed this week’s review, and I look forward to brining you more easy to digest, relevant and interesting content from the worlds of Cardiology, health and wellness in 2024.
Happy New year!!