Solomon, Scott D; Claggett, Brian L; Miao, Zi Michael; Diaz, Rafael; Felker, G Michael; McMurray, John J V; Metra, Marco; Corbalan, Ramon; Filippatos, Gerasimos; Goudev, Assen R; Mareev, Viatcheslav; Serpytis, Pranas; Suter, Thomas; Yilmaz, Mehmet B; Zannad, Faiez; Kupfer, Stuart; Heitner, Stephen B; Malik, Fady I; Teerlink, John R (2022). Influence of atrial fibrillation on efficacy and safety of omecamtiv mecarbil in heart failure: the GALACTIC-HF trial. European heart journal, 43(23), pp. 2212-2220. Oxford University Press 10.1093/eurheartj/ehac144
Full text not available from this repository. (Request a copy)AIMS
In GALACTIC-HF, the cardiac myosin activator omecamtiv mecarbil compared with placebo reduced the risk of heart failure events or cardiovascular death in patients with heart failure with reduced ejection fraction. We explored the influence of atrial fibrillation or flutter (AFF) on the effectiveness of omecamtiv mecarbil.
METHODS AND RESULTS
GALACTIC-HF enrolled patients with New York Heart Association (NYHA) Class II-IV heart failure, left ventricular ejection fraction ≤35%, and elevated natriuretic peptides. We assessed whether the presence or absence of AFF, a pre-specified subgroup, modified the treatment effect for the primary and secondary outcomes, and additionally explored effect modification in patients who were or were not receiving digoxin. Patients with AFF (n = 2245, 27%) were older, more likely to be randomized as an inpatient, less likely to have a history of ischaemic aetiology or myocardial infarction, had a worse NYHA class, worse quality of life, lower estimated glomerular filtration rate, and higher N-terminal pro-B-type natriuretic peptide. The treatment effect of omecamtiv mecarbil was modified by baseline AFF (interaction P = 0.012), with patients without AFF at baseline deriving greater benefit. The worsening of the treatment effect by baseline AFF was significantly more pronounced in digoxin users than in non-users (interaction P = 0.007); there was minimal evidence of effect modification in those patients not using digoxin (P = 0.47) or in digoxin users not in AFF.
CONCLUSION
Patients in AFF at baseline were less likely to benefit from omecamtiv mecarbil than patients without AFF, although the attenuation of the treatment effect was disproportionally concentrated in patients with AFF who were also receiving digoxin.Clinical Trial Registration: NCT02929329.
Item Type: |
Journal Article (Original Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology |
UniBE Contributor: |
Suter, Thomas |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
1522-9645 |
Publisher: |
Oxford University Press |
Language: |
English |
Submitter: |
Pubmed Import |
Date Deposited: |
25 Mar 2022 10:59 |
Last Modified: |
05 Dec 2022 16:16 |
Publisher DOI: |
10.1093/eurheartj/ehac144 |
PubMed ID: |
35325102 |
Uncontrolled Keywords: |
Atrial fibrillation Digoxin Heart failure Myosin activator |
URI: |
https://boris.unibe.ch/id/eprint/168028 |
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