Kerendia Shown to Reduce CV Event Risk Regardless of Atrial Fibrillation Status | ACC 2025

Kerendia (finerenone), a nonsteroidal mineralocorticoid receptor antagonist, can reduce the risk of heart failure-related events and cardiovascular death in patients with heart failure with mildly reduced or preserved ejection fraction, regardless of what type of atrial fibrillation they had — or if they had no atrial fibrillation at all — according to results of a secondary analysis of data from the FINEARTS-HF trial presented at the American College of Cardiology’s Annual Scientific Session (ACC.25) today in Chicago.

“The efficacy and safety of finerenone were consistent in patients with and without AF,” lead researcher Shingo Matsumoto, M.D., Ph.D., of Toho University in Tokyo and the British Heart Foundation Cardiovascular Research Center in Glasgow, Scotland, reported in a poster presented at the cardiology meeting. The results were published simultaneously in JAMA Cardiology. 

Bayer, the maker of Kerendia, announced before the meeting that 10 presentations of new analyses from the FINEARTS-HF trial were scheduled for ACC.25. The FDA approved Kerendia in July 2021 for adults with chronic kidney disease associated with Type 2 diabetes to reduce the risk of kidney function decline, kidney failure and cardiovascular events, including nonfatal heart attacks and hospitalization for heart failure.

Last week the German pharmaceutical company announced that the FDA has accepted its supplemental New Drug Application and granted priority review designation for Kerendia as a treatment for adult patients with heart failure with mildly reduced or preserved left ventricular ejection fraction. That submission was based on the positive results from the FINEARTS-HF study presented at the European Society of Cardiology Congress last year in London.

Kerendia is priced to cost $686.70 a month, although the actual amount paid by insurers and patients depends on discounts, rebates and how the pharmacy benefits are designed.

The analysis presented today at ACC.25 included 5,984 patients from FINEARTS-HF with a known atrial fibrillation status upon enrollment. Nearly a quarter (23.1%) had paroxysmal atrial fibrillation, and nearly one-third (31.5%) had persistent or permanent atrial fibrillation.

A participant’s atrial fibrillation status did not alter the beneficial effect of Kerendia on the primary endpoint, which was the composite of cardiovascular death and total heart failure events. The event rate was consistently lower in the Kerendia group compared with those in the placebo group: 20% lower in those without atrial fibrillation, 17% lower in those with paroxysmal atrial fibrillation, and 15% lower in those with the persistent or permanent versions of the disease. Overall, the patients taking Kerendia had a 16% lower risk of total heart failure events and cardiovascular deaths.

Having atrial fibrillation at baseline carried a higher risk of the primary endpoint, Matsumoto stated, and the safety profile was consistent across all atrial fibrillation categories.

In those who did not have atrial fibrillation or flutter upon enrollment, the incidence of developing them was low, at 6.5%, the study noted.

The risk of new-onset atrial fibrillation or flutter appeared to be lower in patients randomly assigned to Kerendia, Matsumoto and colleagues reported, but the difference did not reach statistical significance.

However, those patients without atrial fibrillation who went on to develop atrial fibrillation or flutter had almost a four times higher risk of a heart failure event or death related to cardiovascular disease, according to the results reported by Matsumoto.