Key result
Higher CA-125 is not linked to increased HF hospitalization or CV death in chronic HF.
Why the study?
The role of CA-125 as a biomarker of congestion or for prognosis across the full ejection fraction spectrum of chronic heart failure was unknown.
Does CA-125 concentration predict heart failure hospitalization or cardiovascular death in patients with chronic heart failure across the ejection fraction spectrum?
RCT (n=1,111)
Does CA-125 concentration predict heart failure hospitalization or cardiovascular death in patients with chronic heart failure across the ejection fraction spectrum?
Effect estimate: HR 1.34 (95% CI 0.91-1.96)
p-value: p=0.11
CA-125 concentrations may serve as a prognostic biomarker for heart failure hospitalization and cardiovascular death in patients with HFrEF, but not in those with HFpEF.
Does not support CA-125 for risk stratification in chronic HF overall; leaves open possible HFrEF-specific utility.
AIM: Vascular congestion may lead to an increase of carbohydrate antigen 125 (CA-125). The role of CA-125 as a biomarker of congestion or for prognosis across the full ejection fraction (EF) spectrum of chronic heart failure (HF) remains unknown. METHODS AND RESULTS: Serum CA-125 was measured in 1111 study participants from the EMPEROR-Reduced and EMPEROR-Preserved trials. Congestive signs and symptoms were evaluated across CA-125 tertiles. Cox regression was used to study the association with outcomes. The primary outcome was a composite of first HF hospitalization or cardiovascular (CV) death. No significant association was present between baseline CA-125 levels and congestive signs or symptoms. In the overall population, higher CA-125 levels were not associated with an increased risk of primary outcome (tertile 3 vs. tertile 1: hazard ratio [HR] 1.34; 95% confidence interval [CI] 0.91-1.96; p-trend = 0.11). However, higher CA-125 levels were associated with an increased risk of primary outcome in patients with HF and reduced EF (HFrEF; tertile 3 vs. tertile 1: HR 2.25 [95% CI 1.30-3.89]), but not among patients with preserved EF (HFpEF; tertile 3 vs. tertile 1: HR 0.68 [95% CI 0.38-1.21]); interaction-p = 0.02). Patients in the upper CA-125 tertile also showed the steepest estimated glomerular filtration rate decline over time (p-trend = 0.03). The effect of empagliflozin to reduce the risk of CV death or HF hospitalization appeared to be attenuated in those with lower baseline CA-125 levels (interaction-p-trend = 0.09). CONCLUSION: Across the range of EF in patients with chronic HF enrolled in the EMPEROR trials, the majority of whom did not have clinical evidence of congestion, CA-125 concentrations were not significantly associated with congestive signs or symptoms. CA-125 concentrations may predict HF hospitalization/CV death in patients with HFrEF, but not those with HFpEF. CLINICAL TRIAL REGISTRATION: EMPEROR-Reduced (NCT03057977), EMPEROR-Preserved (NCT03057951).
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Ferreira et al. (2024) conducted an RCT in Chronic heart failure (n=1,111). Higher CA-125 levels (tertile 3) vs. Lower CA-125 levels (tertile 1) was evaluated on Composite of first HF hospitalization or cardiovascular (CV) death (HR 1.34, 95% CI 0.91-1.96, p=0.11). Higher CA-125 levels were not significantly associated with an increased risk of first HF hospitalization or CV death in the overall chronic heart failure population (HR 1.34; 95% CI 0.91-1.96).
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