TY - JOUR
T1 - Recurrent Hospitalizations and Response to Vericiguat in Heart Failure and Reduced Ejection Fraction
AU - VICTORIA Study Group
AU - Mentz, Robert J.
AU - Stebbins, Amanda
AU - Butler, Javed
AU - Chiang, Chern En
AU - Ezekowitz, Justin A.
AU - Hernandez, Adrian F.
AU - Hilkert, Robert
AU - Lam, Carolyn S.P.
AU - McDonald, Kenneth
AU - O'Connor, Christopher M.
AU - Pieske, Burkert
AU - Ponikowski, Piotr
AU - Roessig, Lothar
AU - Sweitzer, Nancy K.
AU - Voors, Adriaan A.
AU - Anstrom, Kevin J.
AU - Armstrong, Paul W.
N1 - Publisher Copyright:
© 2024 American College of Cardiology Foundation
PY - 2024/5
Y1 - 2024/5
N2 - Background: In VICTORIA (Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction), vericiguat compared with placebo reduced cardiovascular death or heart failure (HF) hospitalization in patients with HF with reduced ejection fraction. Objectives: This study explored the association between vericiguat and recurrent hospitalizations and subsequent mortality after HF hospitalization. Methods: The treatment effect of vericiguat on the burden of HF hospitalizations was evaluated by assessing total HF hospitalization and cardiovascular death in the overall trial and based on baseline N-terminal pro–B-type natriuretic peptide levels with and without adjustment for VICTORIA model covariates (ie, baseline variables associated with the primary endpoint) assessed via the Andersen-Gill method. Associations between vericiguat and recurrent hospitalization and mortality adjusted for VICTORIA model covariates are reported. Results: There were 1,222 total HF hospitalizations and cardiovascular deaths among 2,526 patients in the vericiguat group and 1,336 total events among 2,524 patients in the placebo group (unadjusted HR: 0.89 [95% CI: 0.81-0.97] and adjusted HR: 0.92 [95% CI: 0.84-1.01]). In the subgroup with N-terminal pro–B-type natriuretic peptide levels ≤2,816 pg/mL (ie, Q1 and Q2; median or below), there was a suggestion of a benefit with vericiguat (adjusted HRs of 0.80 [95% CI: 0.64-1.01] and 0.77 [95% CI: 0.62-0.94], respectively) compared with those above this value (adjusted HRs of 1.12 [95% CI: 0.93-1.34] and 0.87 [95% CI: 0.74-1.04] for Q3 and Q4). There was no significant difference in treatment effect between patients with vs without an HF hospitalization. After HF hospitalization, the all-cause mortality rate (events per 100 patient-years) was 48.6 for vericiguat and 44.1 for placebo. Conclusions: Additional investigation of the association between vericiguat and cardiovascular death and total HF hospitalizations by recurrent event analysis did not show a statistically significant reduction in events. Mortality was high after HF hospitalization, emphasizing the need for further therapies to reduce morbidity and mortality.
AB - Background: In VICTORIA (Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction), vericiguat compared with placebo reduced cardiovascular death or heart failure (HF) hospitalization in patients with HF with reduced ejection fraction. Objectives: This study explored the association between vericiguat and recurrent hospitalizations and subsequent mortality after HF hospitalization. Methods: The treatment effect of vericiguat on the burden of HF hospitalizations was evaluated by assessing total HF hospitalization and cardiovascular death in the overall trial and based on baseline N-terminal pro–B-type natriuretic peptide levels with and without adjustment for VICTORIA model covariates (ie, baseline variables associated with the primary endpoint) assessed via the Andersen-Gill method. Associations between vericiguat and recurrent hospitalization and mortality adjusted for VICTORIA model covariates are reported. Results: There were 1,222 total HF hospitalizations and cardiovascular deaths among 2,526 patients in the vericiguat group and 1,336 total events among 2,524 patients in the placebo group (unadjusted HR: 0.89 [95% CI: 0.81-0.97] and adjusted HR: 0.92 [95% CI: 0.84-1.01]). In the subgroup with N-terminal pro–B-type natriuretic peptide levels ≤2,816 pg/mL (ie, Q1 and Q2; median or below), there was a suggestion of a benefit with vericiguat (adjusted HRs of 0.80 [95% CI: 0.64-1.01] and 0.77 [95% CI: 0.62-0.94], respectively) compared with those above this value (adjusted HRs of 1.12 [95% CI: 0.93-1.34] and 0.87 [95% CI: 0.74-1.04] for Q3 and Q4). There was no significant difference in treatment effect between patients with vs without an HF hospitalization. After HF hospitalization, the all-cause mortality rate (events per 100 patient-years) was 48.6 for vericiguat and 44.1 for placebo. Conclusions: Additional investigation of the association between vericiguat and cardiovascular death and total HF hospitalizations by recurrent event analysis did not show a statistically significant reduction in events. Mortality was high after HF hospitalization, emphasizing the need for further therapies to reduce morbidity and mortality.
KW - heart failure with reduced ejection fraction
KW - outcomes
KW - prognosis
KW - vericiguat
UR - http://www.scopus.com/inward/record.url?scp=85191007264&partnerID=8YFLogxK
U2 - 10.1016/j.jchf.2023.12.005
DO - 10.1016/j.jchf.2023.12.005
M3 - Article
C2 - 38363272
AN - SCOPUS:85191007264
SN - 2213-1779
VL - 12
SP - 839
EP - 846
JO - JACC: Heart Failure
JF - JACC: Heart Failure
IS - 5
ER -