CVOT summit report 2024: new cardiovascular, kidney, and metabolic outcomes

Table 6 Key information of the FINEARTS-HF trial [63]

FINEARTS-HF [63]
Class & cardiovascular (CV) outcomes	Effect of finerenone vs placebo (95% CI)*	p-value
Primary outcome
Composite of total worsening HF events^◊ and CV death	0.84 (0.74 to 0.95)^#	0.007
Secondary outcomes
Mean change from baseline in KCCQ-OSS at 6, 9, and 12 months (points)	1.6 (0.8 to 2.3)^¤	< 0.001
Improvement in NYHA functional class at 12 months	1.01 (0.88 to 1.15)^¥	–
Kidney composite outcomes^†	1.33 (0.94–1.89)^§	–
Death from any cause	0.93 (0.83 to 1.06)^§	–

Adverse events	Event rate (%) finerenone vs. placebo group
Serious adverse events	38.7 vs 40.5
Serum creatinine level ≥ 3.0 mg/dl	2.0 vs. 1.2
Serum potassium level> 5.5 mmol/l	14.3 vs. 6.9
Serum potassium level > 6.0 mmol/l	3.0 vs. 1.4
Serum potassium level < 3.5 mmol/l	4.4 vs. 9.7
Investigator-reported hyperkalemia	9.7 vs 4.2
Hyperkalemia that led to hospitalization	0.5 vs. 0.2
Hyperkalemia that led to death	0 vs. 0

*Effect presented as HR or as between-group estimated difference.
#Rate ratio.
§HR estimated with the use of Cox proportional hazard models.
¤Between-group difference.
¥Odds ratio.
^◊Worsening HF events were defined as a first or recurrent unplanned hospitalization or urgent visit for HF.
†The kidney composite outcome was defined as a composite of a sustained decrease in eGFR) ≥ 50%, sustained decline eGFR to less than 15 ml/min/1.73 m² of body surface area, or the initiation of long-term dialysis or kidney transplantation, assessed in a time-to-event analysis.
BP Blood pressure, CI Confidence interval, CV Cardiovascular, HF Heart failure, HR Hazard ratio, KCCQ-OSS Kansas City Cardiomyopathy Questionnaire Overall Summary Score, NYHA New York Heart Association.

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