Hospitalized HFrEF patients had a higher rate of the cardiovascular death or a worsening heart failure event than outpatients
New findings suggest hospitalized patients with heart failure with reduced ejection fraction (HFrEF) had a higher rate of a composite of cardiovascular death or a worsening heart failure event.
It was additionally shown that omecamtiv mecarbil reduced the risk of this primary outcome when initiated in hospitalized patients and in outpatients.
Led by lead investigator Kieran F. Docherty, MD, BHF Cardiovascular Research Centre, University of Glasgow, the study was presented at the The American College of Cardiology (ACC) 2022 Scientific Sessions in Washington, DC.
Within the GALACTIC-HF trial, omecamtiv mecarbil, in comparison to placebo, reduced the risk of CV death or worsening HF events in patients with HFrEF. By design, 25% of patients in GALACTIC-HF were enrolled during hospitalization for worsening HF.
As hospitalized patients are noted to have lower blood pressure, worse kidney function, may be harder to treat with conventional therapy, and are at a higher risk than outpatients. In hospitalized patients, the safety and efficacy of novel therapies for HF have rarely been examined following initiation.
Included patients in GALACTIC-HF were those in NYHA class II - IV with a LVEF ≤35% and elevated natriuretic peptide levels. They were then randomized either as an in-patient during a hospitalization for worsening HF or as an outpatient, within one year of a worsening HF event (hospitalization or emergency department visit).
Exclusions were noted as systolic blood pressure <85 mm Hg, eGFR <20 ML/min/1.73 m2 and in hospitalized patients, the use of inotropes or vasopressors within 72 hours and use of IV vasodilators or diuretics within 12 hours of screening.
The study’s primary outcome was a composite of cardiovascular death or a worsening HF event, which was thus defined as a hospitalization for HF or an urgent emergency department or clinic visit.
From a total population of 8232 patients analyzed, 2084 (25%) were hospitalized at the moment of randomization. The rate per 100 person-years of the primary outcome was found to be higher in hospitalized patients (placebo = 38.3 per 100 person-years) than in outpatients (23.1 per 100 person-years), at an adjusted hazard ratio of 1.21 (95% CI, 1.12 - 1.31).
The effect of omecamtiv mecarbil versus placebo on the primary outcome was similar in hospitalized patients (HR, 0.89; 95% CI, 0.78 - 1.01) and outpatients (HR, 0.94; 95% CI, 0.86 - 1.02).
Placebo-corrected changes in systolic blood pressure at week 2 and creatinine at week 12 were small and found to be similar in hospitalized patients and outpatients.
“Hospitalized HFrEF patients had a higher rate of the primary outcome than outpatients,” investigators concluded. “[Omecamtiv Mecarbil] reduced the risk of the primary outcome both when initiated in hospitalized patients and in outpatients.”
The study, “The Effect of Omecamtiv Mecarbil in Hospitalized Patients As Compared With Outpatients: A Prespecified Analysis of GALACTIC-HF,” was presented at ACC 2022.