Real‐world eligibility for vericiguat in decompensated heart failure with reduced ejection fraction
Abstract 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 i...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2022-04-01
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| Series: | ESC Heart Failure |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/ehf2.13837 |
| _version_ | 1818306207632326656 |
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| author | Jaewon Oh Chan Joo Lee Jin Joo Park Sang Eun Lee Min‐Seok Kim Hyun‐Jai Cho Jin‐Oh Choi Hae‐Young Lee Kyung‐Kuk Hwang Kye Hun Kim Byung‐Su Yoo Dong‐Ju Choi Sang Hong Baek Eun‐Seok Jeon Jae‐Joong Kim Myeong‐Chan Cho Shung Chull Chae Byung‐Hee Oh Seok‐Min Kang |
| author_facet | Jaewon Oh Chan Joo Lee Jin Joo Park Sang Eun Lee Min‐Seok Kim Hyun‐Jai Cho Jin‐Oh Choi Hae‐Young Lee Kyung‐Kuk Hwang Kye Hun Kim Byung‐Su Yoo Dong‐Ju Choi Sang Hong Baek Eun‐Seok Jeon Jae‐Joong Kim Myeong‐Chan Cho Shung Chull Chae Byung‐Hee Oh Seok‐Min Kang |
| author_sort | Jaewon Oh |
| collection | DOAJ |
| description | Abstract 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 m2] and 11.8% patients had CKD Stage IV (15 ≤ eGFR < 30 mL/min/1.73 m2). 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. |
| first_indexed | 2024-12-13T06:38:49Z |
| format | Article |
| id | doaj.art-80f44211e61549c79cc679b3bafcdeaf |
| institution | Directory Open Access Journal |
| issn | 2055-5822 |
| language | English |
| last_indexed | 2024-12-13T06:38:49Z |
| publishDate | 2022-04-01 |
| publisher | Wiley |
| record_format | Article |
| series | ESC Heart Failure |
| spelling | doaj.art-80f44211e61549c79cc679b3bafcdeaf2022-12-21T23:56:28ZengWileyESC Heart Failure2055-58222022-04-01921492149510.1002/ehf2.13837Real‐world eligibility for vericiguat in decompensated heart failure with reduced ejection fractionJaewon Oh0Chan Joo Lee1Jin Joo Park2Sang Eun Lee3Min‐Seok Kim4Hyun‐Jai Cho5Jin‐Oh Choi6Hae‐Young Lee7Kyung‐Kuk Hwang8Kye Hun Kim9Byung‐Su Yoo10Dong‐Ju Choi11Sang Hong Baek12Eun‐Seok Jeon13Jae‐Joong Kim14Myeong‐Chan Cho15Shung Chull Chae16Byung‐Hee Oh17Seok‐Min Kang18Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Cardiovascular Research Institute Yonsei University College of Medicine 50‐1 Yonsei‐ro, Seodaemun‐gu Seoul 03722 KoreaDivision of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Cardiovascular Research Institute Yonsei University College of Medicine 50‐1 Yonsei‐ro, Seodaemun‐gu Seoul 03722 KoreaDivision of Cardiology Seoul National University Bundang Hospital Seongnam KoreaDivision of Cardiology Asan Medical Center Seoul KoreaDivision of Cardiology Asan Medical Center Seoul KoreaDepartment of Internal Medicine Seoul National University Hospital Seoul KoreaDepartment of Internal Medicine Sungkyunkwan University College of Medicine Seoul KoreaDepartment of Internal Medicine Seoul National University Hospital Seoul KoreaDepartment of Internal Medicine Chungbuk National University College of Medicine Cheongju KoreaDepartment of Internal Medicine Chonnam National University Gwangju KoreaDepartment of Internal Medicine Yonsei University Wonju College of Medicine Wonju KoreaDivision of Cardiology Seoul National University Bundang Hospital Seongnam KoreaDepartment of Internal Medicine Catholic University of Korea Seoul KoreaDepartment of Internal Medicine Sungkyunkwan University College of Medicine Seoul KoreaDivision of Cardiology Asan Medical Center Seoul KoreaDepartment of Internal Medicine Chungbuk National University College of Medicine Cheongju KoreaDepartment of Internal Medicine Kyungpook National University College of Medicine Daegu KoreaDepartment of Internal Medicine Mediplex Sejong Hospital Incheon KoreaDivision of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Cardiovascular Research Institute Yonsei University College of Medicine 50‐1 Yonsei‐ro, Seodaemun‐gu Seoul 03722 KoreaAbstract 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 m2] and 11.8% patients had CKD Stage IV (15 ≤ eGFR < 30 mL/min/1.73 m2). 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.https://doi.org/10.1002/ehf2.13837VericiguatHeart failureEligibilityClinical pharmacologyRegistries |
| spellingShingle | Jaewon Oh Chan Joo Lee Jin Joo Park Sang Eun Lee Min‐Seok Kim Hyun‐Jai Cho Jin‐Oh Choi Hae‐Young Lee Kyung‐Kuk Hwang Kye Hun Kim Byung‐Su Yoo Dong‐Ju Choi Sang Hong Baek Eun‐Seok Jeon Jae‐Joong Kim Myeong‐Chan Cho Shung Chull Chae Byung‐Hee Oh Seok‐Min Kang Real‐world eligibility for vericiguat in decompensated heart failure with reduced ejection fraction ESC Heart Failure Vericiguat Heart failure Eligibility Clinical pharmacology Registries |
| 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 | Vericiguat Heart failure Eligibility Clinical pharmacology Registries |
| url | https://doi.org/10.1002/ehf2.13837 |
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