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Real‐world eligibility for vericiguat in decompensated heart failure with reduced ejection fraction
Aims In 2021, vericiguat was approved by the US Food and Drug Administration (FDA) and the European Commission (EC) for reducing cardiovascular mortality and heart failure (HF) hospitalizations in patients with HF with reduced ejection fraction (HFrEF) based on the Vericiguat Global Study in Subject...
Autores principales: | , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8934970/ https://www.ncbi.nlm.nih.gov/pubmed/35142095 http://dx.doi.org/10.1002/ehf2.13837 |
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author | Oh, Jaewon Lee, Chan Joo Park, Jin Joo Lee, Sang Eun Kim, Min‐Seok Cho, Hyun‐Jai Choi, Jin‐Oh Lee, Hae‐Young Hwang, Kyung‐Kuk Kim, Kye Hun Yoo, Byung‐Su Choi, Dong‐Ju Baek, Sang Hong Jeon, Eun‐Seok Kim, Jae‐Joong Cho, Myeong‐Chan Chae, Shung Chull Oh, Byung‐Hee Kang, Seok‐Min |
author_facet | Oh, Jaewon Lee, Chan Joo Park, Jin Joo Lee, Sang Eun Kim, Min‐Seok Cho, Hyun‐Jai Choi, Jin‐Oh Lee, Hae‐Young Hwang, Kyung‐Kuk Kim, Kye Hun Yoo, Byung‐Su Choi, Dong‐Ju Baek, Sang Hong Jeon, Eun‐Seok Kim, Jae‐Joong Cho, Myeong‐Chan Chae, Shung Chull Oh, Byung‐Hee Kang, Seok‐Min |
author_sort | Oh, Jaewon |
collection | PubMed |
description | Aims In 2021, vericiguat was approved by the US Food and Drug Administration (FDA) and the European Commission (EC) for reducing cardiovascular mortality and heart failure (HF) hospitalizations in patients with HF with reduced ejection fraction (HFrEF) based on the Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction (VICTORIA) trial. However, there has been no report for characterizing the generalizability of vericiguat to real‐world clinical practice. Methods and results The Korean Acute Heart Failure (KorAHF) registry is a multicentre prospective cohort study. A total of 5625 patients who were admitted for HF decompensation were consecutively enrolled. We excluded the patients without left ventricular ejection fraction (LVEF) quantification, patients with LVEF > 45%, patients with in‐hospital death or urgent heart transplantation, and patients without natriuretic peptide measurement. Among a total of 3014 enrolled patients, there were 21.9% patients with lower systolic blood pressure (SBP) (<100 mmHg) and 20.1% patients without elevated natriuretic peptide. Regarding chronic kidney disease (CKD) status, 5.1% patients had CKD Stage V [estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m(2)] and 11.8% patients had CKD Stage IV (15 ≤ eGFR < 30 mL/min/1.73 m(2)). When we analysed these criteria sequentially, 21.9% were excluded from lower SBP, 15.9% were excluded from elevated natriuretic peptide, and 4.2% were excluded from advanced CKD Stage V (9.6% for CKD Stages IV and V). Among the KorAHF registry patients, we found two main reasons for not meeting the inclusion criteria of the VICTORIA trial such as low SBP and non‐elevated natriuretic peptide. Conclusions Among the Korean hospitalized HFrEF patients, 94.9% met the FDA/EC label criteria, while 58% met the inclusion criteria of the VICTORIA trial. Our findings suggest the need for better strategies to integrate up‐to‐date HF treatment in a real‐world HF population, especially decompensated HF patients with low SBP and non‐elevated natriuretic peptide. |
format | Online Article Text |
id | pubmed-8934970 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-89349702022-03-24 Real‐world eligibility for vericiguat in decompensated heart failure with reduced ejection fraction Oh, Jaewon Lee, Chan Joo Park, Jin Joo Lee, Sang Eun Kim, Min‐Seok Cho, Hyun‐Jai Choi, Jin‐Oh Lee, Hae‐Young Hwang, Kyung‐Kuk Kim, Kye Hun Yoo, Byung‐Su Choi, Dong‐Ju Baek, Sang Hong Jeon, Eun‐Seok Kim, Jae‐Joong Cho, Myeong‐Chan Chae, Shung Chull Oh, Byung‐Hee Kang, Seok‐Min ESC Heart Fail Short Communications Aims In 2021, vericiguat was approved by the US Food and Drug Administration (FDA) and the European Commission (EC) for reducing cardiovascular mortality and heart failure (HF) hospitalizations in patients with HF with reduced ejection fraction (HFrEF) based on the Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction (VICTORIA) trial. However, there has been no report for characterizing the generalizability of vericiguat to real‐world clinical practice. Methods and results The Korean Acute Heart Failure (KorAHF) registry is a multicentre prospective cohort study. A total of 5625 patients who were admitted for HF decompensation were consecutively enrolled. We excluded the patients without left ventricular ejection fraction (LVEF) quantification, patients with LVEF > 45%, patients with in‐hospital death or urgent heart transplantation, and patients without natriuretic peptide measurement. Among a total of 3014 enrolled patients, there were 21.9% patients with lower systolic blood pressure (SBP) (<100 mmHg) and 20.1% patients without elevated natriuretic peptide. Regarding chronic kidney disease (CKD) status, 5.1% patients had CKD Stage V [estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m(2)] and 11.8% patients had CKD Stage IV (15 ≤ eGFR < 30 mL/min/1.73 m(2)). When we analysed these criteria sequentially, 21.9% were excluded from lower SBP, 15.9% were excluded from elevated natriuretic peptide, and 4.2% were excluded from advanced CKD Stage V (9.6% for CKD Stages IV and V). Among the KorAHF registry patients, we found two main reasons for not meeting the inclusion criteria of the VICTORIA trial such as low SBP and non‐elevated natriuretic peptide. Conclusions Among the Korean hospitalized HFrEF patients, 94.9% met the FDA/EC label criteria, while 58% met the inclusion criteria of the VICTORIA trial. Our findings suggest the need for better strategies to integrate up‐to‐date HF treatment in a real‐world HF population, especially decompensated HF patients with low SBP and non‐elevated natriuretic peptide. John Wiley and Sons Inc. 2022-02-09 /pmc/articles/PMC8934970/ /pubmed/35142095 http://dx.doi.org/10.1002/ehf2.13837 Text en © 2022 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Short Communications Oh, Jaewon Lee, Chan Joo Park, Jin Joo Lee, Sang Eun Kim, Min‐Seok Cho, Hyun‐Jai Choi, Jin‐Oh Lee, Hae‐Young Hwang, Kyung‐Kuk Kim, Kye Hun Yoo, Byung‐Su Choi, Dong‐Ju Baek, Sang Hong Jeon, Eun‐Seok Kim, Jae‐Joong Cho, Myeong‐Chan Chae, Shung Chull Oh, Byung‐Hee Kang, Seok‐Min Real‐world eligibility for vericiguat in decompensated heart failure with reduced ejection fraction |
title | Real‐world eligibility for vericiguat in decompensated heart failure with reduced ejection fraction |
title_full | Real‐world eligibility for vericiguat in decompensated heart failure with reduced ejection fraction |
title_fullStr | Real‐world eligibility for vericiguat in decompensated heart failure with reduced ejection fraction |
title_full_unstemmed | Real‐world eligibility for vericiguat in decompensated heart failure with reduced ejection fraction |
title_short | Real‐world eligibility for vericiguat in decompensated heart failure with reduced ejection fraction |
title_sort | real‐world eligibility for vericiguat in decompensated heart failure with reduced ejection fraction |
topic | Short Communications |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8934970/ https://www.ncbi.nlm.nih.gov/pubmed/35142095 http://dx.doi.org/10.1002/ehf2.13837 |
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