Good morning, I'm Ankeet Bhatt. I am a cardiologist and clinical investigator at Kaiser Permanante in San Francisco. And today we'll be discussing a pre-specified, secondary analysis from the FINEARTS trial, looking at the impact of finerenone versus placebo on early readmission rates.

What is the reasoning behind the secondary analysis of FINEARTS-HF?

The reasoning behind this secondary analysis was to look at the impact of finerenone versus placebo on early readmission rates amongst patients who are randomised during or shortly after a heart failure hospitalisation.

To just back up a little bit, we know that the public burden of heart failure is substantial. In the United States alone, heart failure accounts for about $30 billion of healthcare expenditures, much of that is related to heart failure hospitalisations. Therefore, there's an imperative need to try to reduce the burden of heart failure and improve that vulnerable period just after our heart failure hospitalisation.

We were interested in whether finerenone compared to placebo in the FINEARTS trial would reduce these early readmissions for heart failure and for other cardiovascular causes.

What was the study design and patient population?

As you know, the study design of the FINEARTS heart failure trial was aimed at assessing the efficacy and safety of finerenone as compared to placebo in patients with mildly reduced or preserved ejection fraction. Importantly, FINEARTS, unlike some of the other trials in mildly reduced and preserved ejection fraction, included a substantial amount of patients who were randomised, either during or shortly after, within seven days of a heart failure hospitalisation.

We analysed those patients of the FINEARTS-HF trial in a pre-specified manner. We examined 30, 60 and 90-day readmissions for heart failure, readmissions for cardiovascular causes and either a heart failure hospitalisation or urgent heart failure visit during this period. And we also looked at the safety of finerenone implemented during or shortly after a hospitalisation amongst these patients.

What were the key findings and how can they be used to identify patients who would benefit most from finerenone?

So we examined just over 1,000 patients who were randomised either during or shortly after a hospitalisation. Our key findings was there was a numerical trend across all heart failure readmissions and cardiovascular readmissions that favored reductions in these endpoints at 30, 60 and 90 days in those who were randomised to finerenone as compared to those who are randomised to placebo.

In addition, importantly for the United States where some of the policy metrics sometimes lead to causes in which patients may be seen in the urgent heart failure outpatient visit rather than a heart failure hospitalisation, we also saw numerical and consistent reductions in the endpoint of readmissions for heart failure or urgent heart failure visits at 30, 60 and 90 days post-randomisation.

How should these findings impact clinical practice?

So the other important point in this was that we also examined safety events during this period. This is a vulnerable period and the proportion of serious adverse and adverse events in those randomised to finerenone versus placebo was very similar across those two groups. So the initiation of finerenone also appeared to be safe amongst this population.

So taken together, these numerical trends that favour reductions in readmissions for heart failure, in addition to a stable and relatively favorable safety profile of this therapy, indicate that this may be an important therapy to be initiated during this vulnerable period following a heart failure hospitalisation.

What further research is needed in this area?

Well, you know, this was one of the larger experiences of administering a guideline, a new therapy for patients with mildly reduced and preserved ejection fraction during this vulnerable period, during or shortly after hospitalisation.

As I mentioned, we included just over 1,000 patients in this population; however, because this represented a subgroup of the larger population, our confidence intervals were wide and not all of these endpoints met statistical significance.

However, there is an ongoing randomised clinical trial called the REDEFINE-HF trial which will examine this question in a dedicated manner in which patients will be randomised to finerenone or placebo, who are all either admitted for heart failure or randomised just after that. So taken together if these findings are confirmed in the REDEFINE trial, initiation of finerenone in this population may represent a disease modifying effect not only in the long-term trajectory of these patients, but also in the short term vulnerable period that these patients face just after heart failure hospitalisations.