Lindberg, F; Øigaard, N; Metra, M; Rosano, GMC; Dahlström, U; Mol, P; Hage, C; Lund, LH; Savarese, G
(2024)
Eligibility for omecamtiv mecarbil in a real-world heart failure population: Data from the Swedish Heart Failure Registry.
PLoS One, 19 (5).
e0303348.
ISSN 1932-6203
https://doi.org/10.1371/journal.pone.0303348
SGUL Authors: Rosano, Giuseppe Massimo Claudio
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Abstract
AIMS: We assessed eligibility for omecamtiv mecarbil (OM) in a real-world cohort with heart failure with reduced ejection fraction (HFrEF) according to the selection criteria of the GALACTIC-HF trial (trial scenario) and selected trial´s criteria more likely to impact real-world use (pragmatic scenario). METHODS AND RESULTS: We included 31,015 patients with HFrEF lasting ≥3 months and registered in the Swedish HF registry between 2000-2021. Trial eligibility was calculated by applying all the GALACTIC-HF selection criteria. The pragmatic scenario considered only the New York Heart Association class, history of worsening HF, N-terminal pro-B-type natriuretic peptides (NT-proBNP), blood pressure and renal failure criteria defined as in the trial. Eligibility for OM in chronic HFrEF was 21% and 36% in the trial and pragmatic scenarios, respectively. Eligibility was higher in those with EF<30% (trial: 27%, pragmatic: 44%), in-patients (trial:30%, pragmatic:57%), severe HF (trial: 35%, pragmatic: 60%), NYHA class III-IV (trial: 26%, pragmatic: 45%), and NT-proBNP≥5,000pg/mL (trial: 30%, pragmatic: 51%). The criteria that most limited eligibility were history of a recent worsening HF event (60% eligible in chronic HFrEF), elevated NT-proBNP (82% eligible), and deviating blood pressure (82% eligible). Overall, eligible patients were characterized by more severe HF and higher CV event-rates in both scenarios, and higher comorbidity burden in the pragmatic scenario. CONCLUSION: Approximately 21% of real-world chronic HFrEF patients would be eligible for OM according to the GALACTIC-HF selection criteria, and 36% according to the criteria more likely to affect OM use in clinical practice. Criteria in both scenarios identified a patient-group with severe HF and high CV event-rates.
Item Type: | Article | ||||||||||||
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Additional Information: | Copyright: © 2024 Lindberg et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. | ||||||||||||
Keywords: | Humans, Heart Failure, Sweden, Male, Registries, Female, Aged, Middle Aged, Stroke Volume, Natriuretic Peptide, Brain, Peptide Fragments, Urea, Eligibility Determination, Patient Selection, Aged, 80 and over, General Science & Technology | ||||||||||||
SGUL Research Institute / Research Centre: | Academic Structure > REF 2021 user group | ||||||||||||
Journal or Publication Title: | PLoS One | ||||||||||||
ISSN: | 1932-6203 | ||||||||||||
Language: | eng | ||||||||||||
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Publisher License: | Creative Commons: Attribution 4.0 | ||||||||||||
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PubMed ID: | 38787867 | ||||||||||||
Web of Science ID: | WOS:001276406500044 | ||||||||||||
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URI: | https://openaccess.sgul.ac.uk/id/eprint/116787 | ||||||||||||
Publisher's version: | https://doi.org/10.1371/journal.pone.0303348 |
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