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ACC.2021: A new analysis of FIDELIO-DKD found patients with chronic kidney disease and type 2 diabetes were about 30% less likely to develop atrial fibrillation vs those treated with placebo.
Patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) treated with finerenone were about 30% less likely to develop atrial fibrillation (AF) than those treated with placebo.
The finding comes from a prespecified exploratory analysis of FIDELIO-DKD, a randomized clinical trial in which the nonsteroidal, selective mineralocorticoid receptor antagonist reduced a composite renal endpoint of sustained decrease in kidney function, kidney failure and renal death in patients with T2D and CKD.
Results of the new analysis were presented at the American College of Cardiology’s 70th Annual Scientific Session and showed new onset AF in 3.2% of patients receiving finerenone and 4.5% of those taking placebo, a relative risk reduction of 39% vs placebo (Hazard ratio 0.71, 95% confidence interval: 0.53-0.94, P=0.0164).
Baseline AF status did not significantly impact the study’s primary or key secondary renal and cardiovascular outcomes (pinteraction: 0.16 and 0.85, respectively).
“Finerenone can lower the risk of development of atrial fibrillation in patients with chronic kidney disease and diabetes and can be used as a therapeutic strategy to delay its onset,” said lead study author Gerasimos Filippatos, MD, from the National and Kapodistrian University of Athens, School of Medicine, Attikon University Hospital in Athens, Greece in an ACC press release. “It can also protect the heart and the kidney from further damage caused by chronic kidney disease and diabetes in these patients with or without preexisting atrial fibrillation.”
FIDELIO-DKD randomly assigned 5,674 patients with CKD and T2D to receive finerenone or placebo with a median follow-up of 2.6 years. Patients were an average of 65-years-old; 69% were men; all had been diagnosed with diabetes for an average of 17 years and all were on optimized doses of renin-angiotensin system blockade, the authors explained. The primary endpoint was a composite of kidney failure, renal death, or sustained decrease in eGFR ≥40% from baseline. Key secondary outcomes included death by loss of heart function, nonfatal heart attack, nonfatal stroke, or hospitalization for heart failure.
In the original findings, finerenone significantly lowered the risk of kidney events by 18% and the risk of cardiovascular events by 14% vs placebo.
For the new analysis, researchers assessed outcomes among patients with and without a history of AF or atrial flutter (AFF) and the risk of patients developing AFF during the study (~8% of participants had AFF at the trial’s start).
They reported that new-onset AFF occurred in 82 (3.2%) patients on finerenone and 117 (4.5%) on placebo (hazard ratio: 0.71; 95% confidence interval: 0.53 to 0.94; p = 0.016).
“The previously-reported kidney and heart protection with finerenone applied equally to patients with and without pre-existing atrial fibrillation,” said Filippatos.
As a possible mechanism behind the effect researchers explained that preclinical studies suggest finerenone may help reduce scarring and thickening of heart tissue, possibly through its mineralocorticoid receptor blockade, according to the ACC statement.
“Treatment in these patients can also be challenging because they are prone to developing blood clots [which can lead to stroke] and bleeding. Finerenone has the potential to reduce the burden of atrial fibrillation in these patients.”
Trial limitations, according to study authors, included the possibility that clinically silent or asymptomatic cases of new-onset AFF may have been missed. A separate trial is underway that will examine the effect of finerenone in patients with less severe CKD and T2D.
The abstract "Finerenone reduces onset of atrial fibrillation in patients with chronic kidney disease and type 2 diabetes," was published simultaneously in the Journal of the American College of Cardiology.