Quality evaluation of the guidelines for vericiguat treatment of heart failure with reduced ejection fraction

Abstract

Background: Heart failure (HF) bears a heavy disease burden, and vericiguat is the only guanylate cyclase stimulator proved to improve its prognosis. However, its clinical use needs a further improvement.

Objective: To evaluate the quality of the guidelines for vericiguat treatment of heart failure with reduced ejection fraction (HFrEF) using the Appraisal of Guidelines for Research & Evaluation Ⅱ (AGREE Ⅱ) instrument, thus providing references for clinical decision-making.

Methods: Clinical guidelines for vericiguat treatment of HFrEF published before 31st March, 2024 were systematically searched in online databases, including the CNKI, Wanfang, VIP, SinoMed, Cochrane Library, Pubmed, and Embase. Eligible articles were screened out by two investigators independently. Quality of the guidelines for vericiguat treatment of HFrEF was evaluated by four investigators from different professional groups using the AGREE Ⅱ instrument.

Results: A total of seven guidelines for vericiguat treatment of HFrEF were enrolled for quality evaluation. Among them, the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure graded the highest score, followed by the 2021 CCS/CHFS Heart Failure Guidelines Update, and the 2021 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure. The Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2023 graded in a moderate level. Significant differences were observed in scores of the stakeholder involvement, rigor of development, and editorial independence. Generally, guidelines for vericiguat treatment of HFrEF shared similar contents, with a moderate quality of evidence. Except for the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2023, and the Korean Society of Heart Failure Guidelines for the Management of Heart Failure 2023 evaluated with a stronger recommendation, the remaining guidelines for vericiguat treatment of HFrEF were equipped with a weaker recommendation.

Conclusion: Referring to guidelines with higher quality, vericiguat is an option for HFrEF patients with a short-term aggravation. Existing recommodations for vericiguat treatment of HFrEF are formulated highly dependent on the findings from the VICTORIA trial, leading to potential biases. More clinical trials are needed for validating the efficacy and safety of vericiguat in treating HFrEF.

Keywords

Vericiguat / Heart failure with reduced ejection fraction / Guidelines / Quality evaluation / AGREE Ⅱ

Declarations

Not applicable.

Authors' contributions

Q. Cai: Conceptualization, methodology, and supervision. T. Li: Methodology, data curation, and writing. L. Chen: Methodology, formal analysis, and investigations. Q. Chen, Z. Wei: Investigations.

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

This study was supported by the China Association for Medical Education special project on Clinical Medication Health Technology Assessment (2023WSJSPGZXKT-15).

Declarations of Competing interests

The authors declare that they have no competing interests.

Acknowledgements

Not applicable

Authors' other information

Not applicable.

References

[1] Wang H, Chai K, Du M, et al. Prevalence and incidence of heart failure among urban patients in China: a national population-based analysis. Circ Heart Fail. 2021; 14(10):e008406.

[2] Aimo A, Castiglione V, Vergaro G, et al. The place of vericiguat in the landscape of treatment for heart failure with reduced ejection fraction. Heart Fail Rev. 2022; 27(4):1165-1171.

[3] Friebe A, Sandner P, Schmidtko A. cGMP: a unique second messenger molecule—Recent developments in cGMP research and development. Naunyn Schmiede Arch Pharm. 2020; 393(2):287-302.

[4] Blanton RM. cGMP signaling and modulation in heart failure. J Cardiovasc Pharm. 2020; 75(5):385-398.

[5] Sun Y, Guo SY, Long MZ. Research progress on vericiguat in the treatment of chronic heart failure. Int J Cardiovasc Dis. 2023; 50(02):78-80.

[6] Jia XY, An JY, Peng KL, et al. Network meta-analysis of the efficacy and safety of soluble guanylate cyclase agonists in heart failure. Chin J N Drugs Clin Remedial. 2023; 42(01):48-57.

[7] Armstrong PW, Pieske B, Anstrom KJ, et al. Vericiguat in patients with heart failure and reduced ejection fraction. N Engl J Med. 2020; 382(20):1883-1893.

[8] Shea BJ, Reeves BC, Wells G, et al. AMSTAR 2: a critical appraisal tool for systematic reviews that include randomized or non-randomized studies of healthcare interventions, or both. BMJ. 2017; 358(8122):j4008.

[9] Tao H, Yang LT, Ping A, et al. Interpretation of the quality evaluation tool AMSTAR 2 for systematic reviews of randomized or non-randomized preventive studies. Chinese. J EvidBased Med. 2018; 18(1):101-108.

[10] Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure: a report of the American college of Cardiology/American heart association joint committee on clinical practice guidelines. Circulation. 2022; 145(18):e1033.

[11] McDonald M, Virani S, Chan M, et al. CCS/CHFS heart failure guidelines update: defining a new pharmacologic standard of care for heart failure with reduced ejection fraction. Can J Cardiol. 2021; 37(4):531-546.

[12] McDonagh TA, Metra M, Adamo M, et al. 2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021; 42(36):3599-3726.

[13] Al Habeeb W, Tash A, Elasfar A, et al. 2023 national heart Center/Saudi heart association focused update of the 2019 Saudi heart association guidelines for the management of heart failure. J Saudi Heart Assoc. 2023; 35(1):71-134.

[14] Aekarach Ariyachaipanich, Adisai Buakhamsri, Phrommintikul Arintaya, et al. 2022 HFCT focused update of the 2019 HFCT heart failure guidelines: part 1 - heart failure classification and pharmacological treatment for heart failure with reduced ejection fraction (HFrEF). J Med Assoc Thai. 2022;105(11):1153-1159.

[15] Youn JC, Kim D, Cho JY, et al. Korean society of heart failure guidelines for the management of heart failure: treatment. Korean Circ J. 2023; 53(4):217-238.

[16] National Center for Cardiovascular Diseases. et al. National expert committee on heart failure, Chinese medical doctor association heart failure professional committee, National heart failure guidelines 2023. Chin J Heart Fail Cardiomyopathy. 2023; 7(4):215-311. https://doi.org/10.3760/cma.j.issn.101460-20231209-00052

[17] Ju CX, Zhang Y, Liu XL, et al. Methodological quality evaluation of guidelines and consensus for the prevention and treatment of chronic heart failure. Chin J EvidBased Med. 2021; 21(9):1091-1097. https://doi.org/10.7507/1672-2531.202104066

[18] Zhang N, Long YL, Wang XY, et al. Evidence-based construction of the clinical practice guideline transparency evaluation tool 2.0. Chinese. J EvidBased Med. 2023; 23(09):1066-1071.

[19] INAHTA. Vericiguat (cardiac failure) - Benefit assessment according to § 35a Social Code Book V. [2023-11-22]. 〈https://database.inahta.org/article/22635〉.

[20] CADTH. CADTH Reimbursement Review Vericiguat (Verquvo). [2023-11-22]. 〈https://www.cadth.ca/sites/default/files/DRR/2023/SR0758-Verquvo.pdf〉.