The VICTORIA Trial: What It Means for HFrEF Treatment

Posters presented at the American Heart Association Scientific Sessions, held in Chicago, Illinois, November 5-7, 2022, evaluated the outcomes of the VICTORIA trial and what those results mean for the generalizability of the trial and vericiguat for patients hospitalized with heart failure with reduced ejection fraction (HFrEF).

The first poster¹ evaluated the outcomes and insights from the VICTORIA trial, with particular focus on age and sex of the participants. The study aimed to determine the association of age and sex with clinical characteristics, background heart failure (HF) therapy, and the response to vericiguat in the trial.

The VICTORIA trial included 5050 patients with HFrEF and worsening HF with no age limit. Slightly more than a quarter (28%) of participants were women and 31% of participants were aged 75 years and older. Clinical characteristics were compared in all age groups.

There were more women aged 75 years and older compared with men (37% vs 29%). Patients aged 75 years and older had higher ejection fraction and class III/IV symptoms, more comorbidities, lower glomerular filtration rate (eGFR), and the lowest use of triple therapy compared with younger patients. Women had higher ejection fraction and lower burden of some comorbidities in all age groups compared with men, although similar function status was found.

Women aged 75 years and older achieved target doses of triple therapy less often compared with men of a similar age. Women were less likely to have HF devices in all age groups. Cardiovascular death or HF hospitalization incidence increased across age groups and was higher in men. The beneficial effect of vericiguat on cardiovascular death or HF hospitalization was not modified by age and sex.

The researchers concluded that the women in the VICTORIA trial were older than men. Women aged 75 years and older received less intense background HF therapy and their prognosis was better than men aged 75 years and older. They also concluded that the benefit of vericiguat was independent of age and sex.

The second poster² focused on the generalizability of the VICTORIA trial and the FDA label for vericiguat for patients hospitalized with HFrEF. The aim of the study was to understand the generalizability of vericiguat on clinical practice after its approval in January 2021.

Patients with HFrEF of less than 45% were studied in 525 sites from the Get With The Guidelines (GWTG)-HF registry between January 2014 and December 2020. Patients were excluded if they left against medical advice, were transferred to an acute care facility or hospice care, or had missing critical data elements. FDA label criteria and eligibility criteria was approximately applied to the GWTG-HF sample from the VICTORIA trial.

There were 221,730 (92%) patients of the 241,057 included in the study who could be candidates for vericiguat and 92,249 (38%) patients who would have been eligible for the VICTORIA trial. An eGFR below 15 mL/min/1.73 m² was the most frequent reason for ineligibility in the FDA label (5.7%). Sex, race, and clinical characteristics were similar between GWTG-HF participants, FDA label candidates, and VICTORIA trial eligible patients. HF hospitalization, 12-month mortality, and all-cause hospitalization was also similar across the 3 groups in patients aged 65 years and older who were linked to Medicare.

The researchers concluded that more than 9 out of 10 patients hospitalized for HFrEF could be candidates for vericiguat based on the FDA label. Generalizability of the FDA label and the VICTORIA trial to US practice was supported by the patients having similar characteristics in the groups that met or did not meet VICTORIA trial eligibility criteria.

References

1. Lam CS, Pina IL, Zheng Y, et al. Age, sex, and outcomes in heart failure with reduced ejection fraction: insights from the VICTORIA trial. Presented at: AHA 2022; November 5-7, 2022; Chicago, IL. Abstract 498.
2. Greene SJ, Khan MS, Xu H, et al. Generalizability of the Victoria trial and the US FDA label for vericiguat to patients hospitalized for heart failure with reduced ejection fraction in the United States. Presented at: AHA 2022; November 5-7, 2022; Chicago, IL. Abstract SU2152.