Baseline features of the VICTORIA (Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction) trial

Abstract

AimDescribe the distinguishing features of heart failure (HF) patients with reduced ejection fraction (HFrEF) in the VICTORIA (Vericiguat Global Study in Patients with Heart Failure with Reduced Ejection Fraction) trial.Methods and resultsKey background characteristics were evaluated in 5050 patients randomized in VICTORIA and categorized into three cohorts reflecting their index worsening HF event. Differences within the VICTORIA population were assessed and compared with PARADIGM‐HF (Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) and COMMANDER HF (A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction, or Stroke in Participants with Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure). VICTORIA patients had increased risk of mortality and rehospitalization: New York Heart Association class (40% class III), atrial fibrillation (45%), diabetes (47%), hypertension (79%) and mean estimated glomerular filtration rate of 61.5 mL/min/1.73 m2. Baseline standard of HF care was very good: 60% received triple therapy. Their N‐terminal pro‐B‐type natriuretic peptide was 3377 pg/mL [interquartile range (IQR) 1992–6380]. Natriuretic peptides were 30% higher level in the 67% patients with HF hospitalization <3 months, compared to those within 3–6 months of HF hospitalization and those randomized after recent outpatient intravenous diuretic therapy. Overall the median MAGGIC (Meta‐Analysis Global Group in Chronic Heart Failure) risk score in VICTORIA was 23 (IQR 18–27) as compared to the MAGGIC risk score in PARADIGM‐HF of 20 (IQR 16–24).ConclusionsVICTORIA comprises a broadly generalizable high‐risk population of three unique clinical strata of worsening chronic HFrEF despite very good HF therapy. VICTORIA will establish the role of vericiguat, a soluble guanylate cyclase stimulator, in HFrEF.

Heart failure in the last year: progress and perspective

“…Baseline characteristics of VICTORIA‐enrolled subjects showed a high‐risk population when compared with PARADIGM‐HF. The median MAGGIC (Meta‐Analysis Global Group in Chronic Heart Failure) risk score was 23 (interquartile range 18–27) in VICTORIA vs. 20 (interquartile range 16–24) in PARADIGM‐HF trial 198 . In the GALACTIC‐HF (Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure) trial, the selective cardiac myosin activator omecamtiv mecarbil showed a reduction in the primary composite endpoint of a first HF event or death from CV causes 199 …”

“…The median MAGGIC (Meta-Analysis Global Group in Chronic Heart Failure) risk score was 23 (interquartile range 18-27) in VICTORIA vs. 20 (interquartile range 16-24) in PARADIGM-HF trial. 198 In the GALAC-TIC-HF (Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure) trial, the selective cardiac myosin activator omecamtiv mecarbil showed a reduction in the primary composite endpoint of a first HF event or death from CV causes. 199 Neladenoson bialanate, a partial adenosine A1 receptor agonist, failed to demonstrate favourable changes in NT-proBNP, LVEF, high-sensitivity troponin T, or CV mortality and HF hospitalization in PANTHEON trial.…”

The year in cardiovascular medicine 2020: heart failure and cardiomyopathies

“…Aktivator solubilne guanilat ciklaze (sGC) vericiguat istraživan je u studiji VICTORIA na 5050 bolesnika s nedavnom dekompenziranom fazom kroničnog HF i LVEF <45%. 125,126 Vericiguat znatno smanjuje primarni ishod od CV smrti ili prve hospitalizacije zbog HF-a (HR, 0,90; 95 % CI, 0,82 -0,98; P = 0,002). Dok vericiguat signifikantno smanjuje hospitalizacije zbog HF-a (HR, 0,90; 95 % CI, 0,81 -1 ,00), CV smrtnost se nije znatnije smanjila.…”

VICTORIA in context

“…[1][2][3][4][5] The latest of these, soluble guanylate cyclase (sGC) stimulation, was investigated in the large well-conducted, Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction trial (VICTORIA). 4,6,7 This new therapeutic approach is based on the hypothesis that the nitric oxide-sGC-cyclic guanosine monophosphate (cGMP) pathway is downregulated in heart failure and that its stimulation might be beneficial. 4,6,7 VICTORIA was quite different in design than in other recent HFrEF trials as shown in Tables 1 and 2.…”

“…4,6,7 This new therapeutic approach is based on the hypothesis that the nitric oxide-sGC-cyclic guanosine monophosphate (cGMP) pathway is downregulated in heart failure and that its stimulation might be beneficial. 4,6,7 VICTORIA was quite different in design than in other recent HFrEF trials as shown in Tables 1 and 2. [8][9][10] In many respects, VICTORIA was more like prior 'acute' or 'hospitalized' heart failure trials, perhaps most closely resembling the Aliskiren Trial on Acute Heart Failure Outcomes (ASTRONAUT) in requiring both recent/current hospital admission (or equivalent) and an elevation of natriuretic peptide level.…”