5 drug updates from ESC
M3 India Newsdesk Oct 05, 2021
Trials, studies and research in medicine greatly help doctors to keep up with their knowledge and make necessary updations to their daily practice. In this article, we present the five most important trials in cardiology and findings presented at this year's ESC meet.
EMPEROR-Preserved
The EMPEROR-Preserved research was the undisputed hit of the congress. This follow-up research was launched last year for the Emperor Reduced trial and is a multicentre, worldwide, randomised controlled investigation in patients with heart failure with the preserved ejection fraction utilising empagliflozin, an inhibitor of SGLT2.
This is the first research to demonstrate a favourable result in this cohort of patients, who, as many of you are aware, are very difficult to treat. This trial randomly assigned 3000 individuals to receive either placebo or empagliflozin and then followed them for a length of time to assess clinical results. Cardiovascular mortality or the first hospitalisation for heart failure were the primary outcomes.
The research found a very significant decrease in the combined main outcome, as well as a 21% reduction in the relative risk of those events. The majority of the drop is in heart failure admissions, and a subsequent examination of all heart failure episodes revealed a substantial decrease. Cardiovascular death, on the other hand, was not statistically significant on its own.
This research demonstrates that its effect is observed regardless of whether a person has diabetes or not and that the outcomes were consistent across all subgroups. As a result, this is the first research to demonstrate a favourable outcome in patients with heart failure and maintained ejection fraction. This is especially intriguing in light of the PARAGON-HF study's close failure last year.
MASTER DAPT
MASTER DAPT is another research that examines the utilisation of antiplatelet treatment after coronary intervention. The obligatory use of antiplatelets after coronary stenting may create substantial complications in individuals with a high risk of bleeding. And this research randomised individuals with a high risk of bleeding to either normal treatment or a shorter period of DAPT.
All of these patients underwent PCI with the Ultimaster Sirolimus drug-eluting stent and were randomly assigned to either one month or standard treatment. The investigators were free to select which antiplatelet to discontinue, and the majority chose clopidogrel. Around 35% of these individuals were also on oral anticoagulants.
What this research showed was that discontinuing antiplatelet medications after one month was not inferior to continuing them for a combined endpoint of ischaemia events, that it was not inferior for the combination of ischemic events alone, and that it resulted in substantially reduced bleeding.
Thus, the critical issue is whether we can generalise these findings to other stent platforms other than the Ultimaster stent design. At the very least, it provides us with some comfort moving ahead in these patients with a high risk of bleeding.
Figaro DKD
FIGARO-DKD is a follow-up study to the FIDELIO-DKD research released last year. This study examines finerenone, a novel non-steroidal mineralocorticoid antagonist that acts similarly to spironolactone in blocking the mineralocorticoid receptor, but through a different mechanism that seems to have a protective impact on kidney function.
FIDELIO-DKD, which was released last year, demonstrated a 20% decrease in the development of diabetic CKD. And in the FIGARO-DKD trial, they examined a broader spectrum of patients with renal impairment, including individuals with an eGFR of more than 60, which is considered normal, but who had micro or macroalbuminuria. Thus, the presence of protein was a criterion for inclusion in this research.
Researchers demonstrated a 13% decrease in clinical events when compared to placebo. And when we dig further, we see that almost all of the event decrease is due to a 30% drop in heart failure-related events. This is critical since 1 in 6 individuals in the placebo group had a heart failure-related incident requiring hospitalisation. And therefore, this is a critical outcome metric for this population of patients.
Additionally, we find that kidney function is preserved over time, but there are some limitations to the endpoints we chose, and a deeper dig into this really deserves additional evaluation. Thus, we are left with another drug that we may employ to decrease the long-term impairment and development of diabetic kidney disease in individuals with diabetes.
RIPCORD2
The RIPCORD 2 research, a randomised controlled trial headed by the Southampton group, was studied, planned, and started in the United Kingdom. This research examined the use of fractional flow reserve, and instead of measuring it after coronary intervention, as was done in FAME 1 and FAME 2, it advocated for the use of fractional flow reserve, a pressure index determined using a pressure wire, during diagnostic coronary angiography.
They randomly assigned patients undergoing coronary angiograms in the cath lab to receive standard of care or pressure wire evaluation of all major arteries that might be stented or bypassed. They discovered a substantial decrease in the overall number of tests conducted after a pressure-wire guided method in this group of around 1000 patients.
However, the main endpoint, which was intended to demonstrate the cost savings associated with the use of pressure wire technology, was negative. And this was basically negative research, demonstrating no cost savings or adverse events associated with the use of fractional flow reserve during the diagnostic angiography stage.
This is a negative research, as have been many others lately in the area of fractional flow reserves, including FLOWER-MI and the unpublished FUTURE study. This is not to say that fractional flow reserve does not function; rather, it helps us understand when and where we should utilise this very valuable technology for coronary intervention guidance.
ENVISAGE TAVI
The ENVISAGE-TAVI investigation comes next. This research is investigating the use of the NOAC edoxaban, 60 mg, in patients who have just had TAVI, or transcatheter aortic valve implantation. Patients receiving TAVI are frail and a high-risk group, with about 30% to 40% of them having some kind of atrial fibrillation that needs anticoagulation.
Prior research has shown that this group of patients has poor results, and therefore it is worthwhile to conduct randomised control trials to determine the safety and dosage of NOACs in this cohort.
This research compared edoxaban to other vitamin K antagonists, such as warfarin, and found a decrease in the combined endpoint of ischemic and bleeding events. However, when bleeding episodes were considered separately, there was no decrease in bleeding and, in fact, an increase in bleeding with edoxaban 60 mg, which was a rather unexpected result. GI bleeding was substantially increased, as has been seen with other NOACs.
Thus, this is a research with a mixed result that indicates that we may be able to utilise a NOAC after TAVI implantation in this group of patients.
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Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.
The author is a practising super specialist from New Delhi.
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