This transcript has been edited for clarity.
My name is Mamas Mamas. I'm professor of cardiology based at Keele University. So, today we're going to talk about The National Institute for Health and Care Excellence (NICE) consultation document for acute coronary syndromes.
NICE have recently published this on their website and asked for feedback from clinicians, patients, individuals in healthcare. This is to be done before 27th March.
So what does the new document cover? Well, it covers acute coronary syndromes, including NSTEMI, and STEMI, as well as unstable angina.
It's in two parts. So first and foremost, it talks about changes in STEMI management. And there are quite a few changes, but also quite a few things that haven't changed.
So let's look at what has changed. First and foremost, the interesting thing that is particularly evident is the changing antiplatelet management of STEMI. So NICE guidelines now recommend prasugrel as the first line antiplatelet in the management of acute coronary syndromes in STEMI, over ticagrelor and clopidogrel.
And I think this is very much in line with the ISAR-REACT trial that showed superiority of prasugrel over ticagrelor. So, I think this is a reasonable move in line with best evidence.
One of the areas that perhaps was slightly disappointing was that they have stuck with the Radial recommendations from 2013 around adoption of the radial approach as the preferred access site. The recommendation was a fairly weak recommendation. And this really is in contrast to the European Society of Cardiology (ESC) guidelines which give the radial approach a class 1A indication.
So I think it's disappointing, given that there have been a number of randomised control trials since 2013 that have shown efficacy of radial over femoral, that we still only give a weak recommendation. I think the radial approach should be first line in these sorts of patients.
Moving on to NSTEMI, I think that's where most of the changes in the documents have been.
And again, one of the areas of focus is around antiplatelet management and particularly for those that may or may not undergo PCI.
So for those that do undergo PCI, the new guidelines suggest that we should be using prasugrel or ticagrelor.
Now this is slightly confusing because the ISAR REACT 5 trial certainly shows a superiority of prasugrel over ticagrelor, and there was no interaction by presentation syndrome, and so it does seem slightly surprising that they should give equal weight to ticagrelor compared to prasugrel.
In terms of patients not managed with PCI they give the recommendation for ticagrelor. So I think that's quite reasonable.
Furthermore, they skirt around the issue of whether in NSTEMI, patients should be uploaded upfront or after the angiogram.
I think they make quite clear that for prasugrel that should only be given after the angiogram decision for PCI is made. Now for ticagrelor they don't make that recommendation. So I think greater insight should be offered around this.
I think one of the other big disappointments from my perspective, from these latest guidelines, is the issue of which patients to give a coronary angiography to. The old guidelines suggested that we use the GRACE score, and a GRACE score of over 3% risk of mortality at 6 months was classed as intermediate. So anything that with a GRACE score over 3%, the guidelines advocated receipt of cardiac catheterisation. So that's fine.
However, we know that one of the biggest determinants of mortality is age. And so these guidelines, if anything, go against younger patients. Why? If you have a patient who's 40, for example, is tachycardic, with raised enzymes and dynamic ECG changes, his GRACE score comes back as 2% over 6 months. So under current guidelines, this patient would not be offered diagnostic cardiac catheterisation, which seems rather extraordinary.
In contrast, someone who's very elderly will easily get a GRACE score over 3% at 6 months by virtue of their age, and so again, we may be offering unnecessary cardiac catheterisations to the very elderly.
On top of this, one of the other disappointments of the guidelines is in the past the recommendations from presentation to cardiac catheterisation was 96 hours. This has been dropped to 72 hours. I think this is still way too long and we should be doing better.
For example, the ESC guidelines recommend in high-risk coronary cases patients are offered diagnostic cardiac catheterisation within 24 hours. I think 72 hours is suboptimal for these patients, particularly given that now a number of meta-analyses and individual patient meta-analyses of large randomised controlled trials have shown that in the very high-risk patients, that's GRACE score greater than 140, these patients benefit from angiography within 24 hours. So only mandating diagnostic cardiac cath within 72 hours I think is a missed opportunity and places these higher-risk patients at-risk.
The other question, which I don't think they really give insight to, is the question of comorbidities. So in the guidelines they talk about taking into account a patient’s comorbidity level before offering cardiac catheterisation. But they don't really say what they mean by comorbidity.
Does the presence of diabetes equate to comorbidities? Is it a comorbidity score that they are advocating? Is it something else? Is it a measure of comorbidity?
I think we need to be much more granular in what we mean by comorbidity in such guidelines.
I think the final area which has been updated, which I think is slightly problematic is what to do in patients that are anticoagulated. So we know that patients with anticoagulation represent about 1 in 10 of all presentations of acute coronary syndromes. And these patients are really quite challenging to manage, because by virtue of their anticoagulation regimes, they’re at high-risk of bleeding complications. But because they've had a coronary event, they're also a high risk of ischaemic complications. And so trying to balance the risk of ischaemic versus haemorrhagic complications is challenging.
And there have been a large number of randomised controlled trials that have looked at the optimal antiplatelet regimes in this population.
So what do the NICE guidelines say in 2020? I think they skirt around the issue slightly. They say that in patients undergoing PCI, it would be expected that these patients would have dual antiplatelet therapy, but then they go on to say that treatment should be an anticoagulant and clopidogrel for 12 months.
There are a number of problems with this. First and foremost, they don't actually say how long triple therapy, ie aspirin, clopidogrel, and the anticoagulant - should be.
Should it be for a week? Should it be for a month? Should it be for 3 months?
The AUGUSTUS trial randomised patients, and so there were patients with just clopidogrel and anticoagulant, but let's not forget, these patients were often randomised, I think for an average of 12 days after their PCI event.
And so you can't really use this guideline of just using triple therapy during the PCI and then continuing with clopidogrel and coagulant. So I think, really, for guidelines to be useful, they have to be much greater in clarity, in what duration of triple therapy are we going to be giving these patients? And is there a group of patients where perhaps we shorten the triple therapy, for example, those with high bleeding risk.
The second area that I think is slightly problematic in that they talk about anticoagulation, but they don't really separate out things like warfarin versus the newer NOACs. And we know from the various trials looking at optimal antithrombotic therapy in acute coronary syndromes, and in PCI particularly, patients treated with warfarin have far greater risk of TIMI major bleeding events compared to patients with NOACs. And so I think the NICE guidelines really need to come down and be very clear that the optimal management of these patients, particularly for patients with AF, should be the use of NOAC.
Finally, they talk about rehabilitation. They talk about secondary prevention, but there haven't really been huge updates in this and I guess, perhaps, you know, strengthening of the important role of cardiac rehabilitation would have been welcome in this update.
So those are my highlights, or lowlights, of the new 2020 acute coronary syndrome guidelines produced by NICE.
I would thoroughly recommend that you all have a look at them on the website. And if you think that there is something that you feel strongly about, then give feedback to the website.
Thank you very much for joining me.
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Cite this: Prof Mamas Mamas. Has NICE Got It Wrong on Acute Coronary Syndromes? - Medscape - Feb 21, 2020.