COMMENTARY

Top 5 Studies From ESC 2021

Dr Sukh Nijjer

Disclosures

September 14, 2021

This transcript has been edited for clarity.

Hello and welcome to another Medscape UK cardiology video. I'm Dr Sukh Nijjer and I'm an interventional cardiologist working in central London.

I'm going to be talking about my top five trials from the European Society of Cardiology (ESC) Congress 2021.

EMPEROR-Preserved

First up, and the absolute blockbuster of the Congress was the EMPEROR-Preserved study.

This is a follow-up study to the Emperor-Reduced study that was announced last year, and it is a multicentre international randomised controlled study using empagliflozin, an SGLT2 inhibitor, in patients with heart failure with preserved ejection fraction.

This is the first positive outcome study in this cohort of patients, which many of you will know are very difficult to treat indeed.

This study took 3000 patients in each arm and randomised them to either placebo or empagliflozin and then followed them over a period of time to look for clinical outcomes.

The principal outcomes were either cardiovascular death or first hospitalisation due to heart failure.

The study was strongly positive, showing a highly significant reduction in the combined primary outcome with a 21% relative risk reduction in those events.

Most of that reduction is in heart failure admission, and in the secondary analysis that looked at all heart failure events, this showed there was a significant reduction. Cardiovascular death, however, was not significant on its own.

This study shows its outcome is seen whether you have diabetes or not, and the outcomes were the same across all subgroups. Therefore, we have the first positive outcome study in patients with heart failure with preserved ejection fraction. And this is super exciting after the narrow miss of the PARAGON-HF study last year.

Figaro DKD

Next up, we're going to look at the FIGARO-DKD study, itself a follow up to the FIDELIO-DKD study that was also published last year.

This is looking at finerenone, a unique nonsteroidal mineralocorticoid antagonist that has a function to block the mineralocorticoid receptor, much like spironolactone, however, using its own unique mechanism that seems to have a protective effect on kidney function.

FIDELIO-DKD that was published last year showed there was a reduction in the progression of diabetic CKD by about 20%. And in the FIGARO-DKD study, they looked at a wider range of patients with renal impairment, and even included those patients with an eGFR of more than 60, which can be considered normal, but patients were recruited if they had micro or macro albuminuria. And so the presence of protein was an inclusion factor in this particular study.

What they showed was a 13% reduction in clinical events compared to placebo. And when we drill into this, almost all of the event reduction is driven by a 30% reduction in heart failure-related events. Now, this is profoundly important because in the placebo arm, 1 in 6 patients had a heart failure type event that led to hospitalisation. And so clearly, this is an important outcome measure for this group of patients.

We also see that there is preservation of kidney function over a period of time, although there are some difficulties in the endpoints that we used, and a deep dive into this really warrants a further assessment on this.

So what we're left with is another medication that we can use in patients with diabetic kidney disease in order to reduce their long term impairment and progression of kidney disease.

ENVISAGE TAVI

Next up is the ENVISAGE-TAVI study. This is a study that's looking at the use of the NOAC edoxaban, 60 mg, in those patients that have just undergone TAVI or transcatheter aortic valve implantation.

As many of you know, patients who are undergoing TAVI are fragile and a cohort of patients that have significant risks, and around 30% to 40% of them have atrial fibrillation of some type that requires anticoagulation.

Prior studies have shown poor outcomes in this group of patients, and therefore it is worth performing randomised control studies to look to see the safety and the dosing of NOACs in this cohort.

This particular study used edoxaban versus traditional vitamin K antagonists, such as warfarin, and has shown that there was a reduction in the combined endpoint of ischaemic and bleeding events. However, when you looked into the bleeding events on its own, there was not a reduction and in fact, there was an increase in bleeding on edoxaban 60 mg, which was a somewhat surprising finding.

In particular GI bleeding was significantly elevated, as has been seen with other NOAC agents.

So that this is a study that has a mixed outcome and that suggests that we can potentially use a NOAC after a TAVI has been implanted in this cohort of patients.

MASTER DAPT

Next up, we have the MASTER DAPT study, which is another look at the use of antiplatelet therapy after coronary intervention. As you know, the mandatory need for antiplatelets after coronary stenting can cause significant issues with patients at high bleeding risk. And this study looked at those patients with high bleeding risk, and randomised them to either usual care or a shortened duration of DAPT.

All of these patients had undergone PCI with the Ultimaster Sirolimus drug eluting stent, and they were randomised to either one month or standard therapy. Investigators could choose which of the antiplatelets to stop, and the majority continued on clopidogrel.

Many of these patients - around 35% - were also on oral anticoagulants.

What this study shows was, there was non-inferiority of stopping the antiplatelet agents at one month, for a combined endpoint of ischaemic events, and it was non inferior for the combination of ischaemic events alone, and it showed significantly less bleeding.

So the question really is whether we can extrapolate this particular set of results to other stent platforms outside of the Ultimaster stent design. At least, it provides us with some reassurance going forward in these high bleeding risk patients.

RIPCORD2

And finally, we have the RIPCORD 2 study, a randomised controlled study that was investigated, designed and initiated, performed here in the United Kingdom, led by the Southampton group, and Professor Nick Curzen, and Rod Stables from Liverpool.

This study looked at the use of fractional flow reserve, and rather than measuring that at the time of coronary intervention, as was performed in FAME 1 and FAME 2, this pushed the use of fractional flow reserve, a pressure index measured using the pressure wire, at the stage of diagnostic coronary angiography.

They took patients who were coming for a coronary angiogram in the cath lab and randomised them to standard of care versus pressure wire assessment of all major vessels that could be stented or have a bypass graft.

In this cohort of around 1000 patients, they found that there was a significant reduction in the total number of tests performed after a pressure-wire guided approach.

However, the primary endpoint, which was geared around a cost saving of using pressure wire technology, was negative. And this was essentially a negative study and showed no benefit in terms of cost saving or clinical events in using fractional flow reserve at the diagnostic angiogram stage.

This is a negative study, along with several other negative studies recently in the context of a fractional flow reserve, including FLOWER-MI and the FUTURE study that remains unpublished.

This doesn't mean that fractional flow reserve doesn't work; it just helps understand where and when we should be performing this very useful technology in the guidance of coronary intervention.

So those were my top five studies from the ESC 2021. I hope you found that useful and I’d very much appreciate your feedback. Do please leave a comment below this video. Many thanks.

You can follow Dr Sukh Nijjer on Twitter.

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