The following article is a part of conference coverage from the American College of Cardiology’s 71st Annual Scientific Session & Expo being held in Washington, DC, from April 2 to 4, 2022. The team at Cardiology Advisor will be reporting on the latest news and research conducted by clinicians and scientists in the field. Check back for more from the ACC 2022 .
The use of omecamtiv mecarbil reduces the risk for cardiovascular (CV) death or a worsening heart failure (HF) event when initiated among both hospitalized patients and outpatients with heart failure with reduced ejection fraction (HFrEF). These findings were presented at the American College of Cardiology 71st Annual Scientific Session & Expo, from April 2nd through 4th, in Washington, DC.
This study was a prespecified analysis of the double-blind, randomized, placebo-controlled, multicenter, phase 3 GALACTIC-HF trial (ClinicalTrials.gov identifier: NCT02929329) was conducted. In GALACTIC-HF, treatment with omecamtiv mecarbil vs placebo was shown to reduce the risk for CV death or worsening HF events in patients with HFrEF. Overall, 25% of the participants in GALACTIC-HF were enrolled during hospitalization for worsening HF.
It is well known that among hospitalized patients, blood pressure is often lower and kidney function is often worse. Further, it may be more difficult to treat hospitalized patients with HF with conventional therapy, and these individuals are at a higher risk for worse outcomes compared with outpatients.
Recognizing that the safety and efficacy of novel therapies for HF are rarely evaluated following initiation in hospitalized patients, the investigators sought to compare the effect of omecamtiv mecarbil in hospitalized patients vs outpatients with HFrEF. The primary study outcome was a composite of CV death or a worsening HF event (defined as hospitalization for HF or an emergency department or urgent clinic visit).
In GALACTIC-HF, patients with New York Heart Association class II to IV, a left ventricular ejection fraction of 35% or smaller, and elevated natriuretic peptide levels were included in the study. Participants were randomly assigned either as inpatients during a hospitalization for worsening HF or as an outpatients within 1 year of a worsening HF event. Key exclusion criteria were systolic blood pressure of less than 85 mm Hg, estimated glomerular filtration rate of less than 20 mL/min/1.73 m2, the use of inotropes or vasopressors within 72 hours of screening, and the use of intravenous vasodilators or diuretics within 12 hours of screening.
Among a total of 8232 patients who were analyzed, 25% of them were hospitalized at the time of randomization. The rate per 100 person-years of the primary outcome was higher among hospitalized patients (placebo arm: 38.3 per 100 person-years) compared with outpatients (23.1 per 100 person-years), yielding an adjusted hazard ratio (HR) of 1.21 (95% CI, 1.12-1.31).
The effect of omecamtiv mecarbil vs placebo on the primary outcome was similar among hospitalized patients and outpatients (HR, 0.89 [95% CI, 0.78-1.01] vs HR, 0.94 [95% CI, 0.86-1.02], respectively; interaction P =.50).
The placebo-corrected changes in systolic blood pressure at week 2 and in creatinine level at week 12 were small and were similar among hospitalized patients and outpatients.
“Hospitalized HFrEF patients had a higher rate of the primary outcome than outpatients,“ the investigators noted. “[Omecamtiv mecarbil] reduced the risk of the primary outcome both when initiated in hospitalized patients and in outpatients.”
Disclosure: None of the study authors has declared affiliations with biotech, pharmaceutical, and/or device companies.
Docherty KF, Claggett B, Diaz R, et al. The effect of omecamtiv mecarbil in hospitalized patients as compared with outpatients: a prespecified analysis of GALACTIC-HF. Presented at: American College of Cardiology 71st Annual Scientific Session & Expo; April 2-4, 2022; Washington, DC.
Visit Cardiology Advisor’s conference section for complete coverage of ACC 2022.