Paul W. Armstrong, MD from the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada and the Merck speaks about the ACC 2021 Abstract - Coronary Artery Disease and Cardiovascular Outcomes in Heart Failure: Insights from the VerICiguaT Global Study in Patients With Heart Failure and Reduced Ejection Fraction (VICTORIA).
Link to Study:
The trial's purpose was to compare vericiguat to placebo in individuals with chronic heart failure (CHF) caused by a low ejection fraction (EF). Vericiguat boosts the activity of soluble guanylate cyclase. This may assist to enhance cardiac and vascular function by increasing the generation of cyclic guanosine monophosphate.
Design of the Research
* This is a randomized sample.
* Double-blind study
Vericiguat (n = 2,526) versus placebo (n = 2,524) were given to CHF patients. Vericiguat was begun at 2.5 mg per day, then raised to 5 mg, then 10 mg per day.
* The total number of students enrolled is 5,050.
* Follow-up period: 12 months
* The average patient is 68 years old.
* Females account for 24% of the total.
Criteria for inclusion:
* CHF; New York Heart Association class II-IV, left ventricular EF 45%, and heart failure treatment based on guidelines.
* A recent hospitalization for heart failure or the administration of an intravenous diuretic
* Natriuretic peptides elevated; N-terminal pro–B-type natriuretic peptide (NT-proBNP) 1000 pg/ml (1600 pg/ml if atrial fibrillation) or BNP 300 pg/ml (500 pg/ml if atrial fibrillation).
* Clinically stable (systolic blood pressure 100 mm Hg for 24 hours and no IV diuretics)
Criteria for exclusion:
* Nitrates with a lengthy half-life, phosphodiesterase type 5 inhibitors, and riociguat
* Awaiting a heart transplant, using continuous intravenous diuretics, or using a ventricular assist device now or in the future.
* Dialysis or chronic renal disease (evaluated glomerular filtration rate of 15 ml/min/1.73 m2)
* Severe pulmonary illness that necessitates the use of oxygen on a continual basis
* Hepatic insufficiency (severe)
* Cardiovascular comorbidities that can be treated
Other noteworthy features/characteristics include:
* The average EF is 29%.
* In 89 percent of cases, the target dosage of vericiguat was met.
The Most Important Findings:
Cardiovascular mortality or heart failure hospitalization occurred in 35.5 percent of the vericiguat group compared to 38.5 percent of the placebo group (hazard ratio [HR] 0.90, p = 0.019). The major outcome risk for vericiguat vs. placebo was 0.84% for those aged 75 years and 1.04% for those aged 75 years (p for interaction = 0.030).
Secondary effects include:
* Cardiovascular death: 16.4% in the vericiguat group vs. 17.5 percent in the placebo group (p = 0.27)
* Death from any cause: 20.3 percent in the vericiguat group vs. 21.2 percent in the placebo group (p = 0.38)
* Hospitalization for heart failure: 27.4 percent of the vericiguat group vs. 29.6 percent of the placebo group (p = 0.048).
* Serious adverse event: 32.8 percent of the vericiguat group versus 34.8 percent of the placebo group had a serious adverse event.
A new technique of boosting soluble guanylate cyclase activity with vericiguat proved successful in individuals with CHF who had recently decompensated. Vericiguat was shown to be more efficacious than placebo in lowering cardiovascular mortality and hospitalization for heart failure. There was a possibility of a greater advantage for those above the age of 75. Vericiguat did not appear to reduce all-cause mortality when compared to placebo. Vericiguat was well tolerated and did not need renal function or electrolyte monitoring. Vericiguat might be a potential therapy option for individuals who have recently had heart failure decompensation.