Researchers presented new data on patient characteristics and outcomes seen in the VICTORIA trial of vericiguat.
New data from the Vericiguat Global Study in Subjects With Heart Failure with Reduced Ejection Fraction (VICTORIA) were presented at the American College of Cardiology (ACC)’s 71st Scientific Session highlighting unique characteristics of patients with heart failure with reduced ejection fraction (HFrEF) included in the trial.
Vericiguat is a soluble guanylate cyclase activator; it was approved for this patient population in January 2021. Previous analyses of VICTORIA data show patients who received vericiguat were 10% less likely to experience the primary outcome, defined as a composite of death from cardiovascular causes or first HF hospitalization (HFH).
In an effort to assess the relation between left ventricular ejection fraction (LVEF), HF biomarkers, and outcomes in those with HFrEF, and to investigate any link between baseline LVEF and the safety and efficacy of vericiguat, researchers divided patients into subgroups based on LVEF tertiles (≤24%, 25%-33%, and > 33%).1
All individuals in VICTORIA had worsening HF and LVEF below 45% and were randomized to either placebo or vericiguat. At baseline, ithe nvestigators also measured N-terminal T-pro hormone BNP (NT-proBNP), cardiac troponin T, growth/differentiation factor-15, interleukin (IL)-6, high-sensitivity C-reactive protein (hsCRP), and cystatin C.
The mean (SD) patient LVEF was 29% (8%), with a range of 5% to 44%.
Consistent rates of treatment discontinuation resulting from adverse events were seen across tertiles. Overall data reveal those with lower LVEF exhibited a distinctive biomarker profile that reflected a higher risk for adverse clinical outcomes.
“There was no statistically significant interaction for the benefit of vericiguat across LVEF tertiles, but the effect was attenuated at higher LVEF,” the authors concluded.
In an additional abstract presented at ACC, investigators sought to classify and assess implications of HF events of among patients enrolled in the trial.2
“While HFH events vary in severity and implications, they are generally considered equally in analyzing clinical trial outcomes,” the researchers explained.
All HFH events that took place during VICTORIA were prospectively adjucated by a blinded, central clinical events committee (CEC), while in the current investigation, HF events were assessed based on frequency, clinical impact via determinations of severity, and treatment effect by event categories.
Of the 5050 enrolled participants, 2559 HF events took place.
Just over 200 HF events in the placebo arm required an urgent visit, while just under 200 in the treatment arm required the same. IV inotropes were the second-most common treatments required for HF events in both arms.
Overall, the events varied significantly in severity and clinical implications, the authors concluded, while “the treatment benefit of vericiguat was generally consistent across different HF event types.”