Since the publication of the PARADIGM-HF study results, the role of angiotensin receptor enkephalinase inhibitors (ARNIs) in the treatment of heart failure has continued to increase. The latest 2022 ACC Heart Failure Guidelines recommend ARNI as first-line treatment for HFrEF heart failure, with preference for angiotensin-converting enzyme inhibitor (ACEI)/angiotensin II receptor blocker (ARB) use[1]< /sup>. Although many studies on ARNI (such as PARADIGM-HF study, PIONEER-HF, etc.) have confirmed the efficacy and safety of sacubitril and valsartan in patients with HFrEF, ARNI in China The application in patients still lacks the support of local evidence-based medicine, and its efficacy and safety are still concerned:
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< span>✔ Can ARNI improve clinical parameters and NYHA class in Chinese HFrEF patients? strong>
✔ < span>Has the patient hospitalization rate improved?
✔ Is the 200mg bid regimen suitable for Chinese patients?
✔ How safe is it for long-term use?
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In order to explore these questions, we contacted Li Xinli, Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University Professor, interpreting the REALITY-HF[2] real-world study of sacubitril-valsartan (ARNI) in China for everyone.
*REALITY-HF aims to explore ARNI treatment patterns in Chinese patients, collecting data on prescribed doses, titration patterns, and patient characteristics.
Patient baseline characteristics
REALITY-HF study included 984 patients, 1 missing. The included patients were 80.5% male and 19.5% female, with a mean EF value of less than 30%. Table 1. Baseline Characteristics of Patients in the REALITY-HF Study
2. NYHA classificationAfter receiving sacubitril-valsartan treatment, the NYHA classification of cardiac function of patients was evaluated every month, and the data showed that the proportion of NYHA classification improved by This improved from 9.6% at month 1 to 21.9% at month 6, in addition to an improvement of more than 20% of patients at month 2/3/6 (Figure 1). Figure 1. Acceptance of sacubitril valsartan The proportion of patients with improved NYHA classification after treatment
3. Sacubitril and valsartan significantly reduced the level of NT-proBNP after 1 week of treatment, and continued to improve for 6 months The mean value of N-terminal B-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide (NT-proBNP) increased from 2223.328 after 1 week of sacubitril-valsartan treatment. pg/ml decreased to 1701.55 pg/ml, P<0.0001, and NT-proBNP levels gradually decreased over the subsequent 6 months (Fig. 2). Figure 2. Changes in NT-proBNP levels after treatment with sacubitril-valsartan
/p>4. Reduced hospitalization rates in patients treated with sacubitril-valsartanCompared with baseline data, the number of patients hospitalized after receiving sacubitril-valsartan decreased significantly, with the proportion of hospitalizations dropping from 75.6% at baseline to 37.4% after 6 months (Figure 3). Figure 3. Hospitalization rates of patients receiving sacubitril-valsartan before and after treatment
The primary endpoint of the REALITY-HF study above confirmed that ARNI can not only improve cardiac function in Chinese HFrEF patients, but also reduce hospitalization rate and disease burden. In order to further explore whether different comorbidities have an impact on the efficacy of ARNI, the study conducted subgroup analysis for different comorbidities, including CHD (coronary heart disease), DCM (dilated cardiomyopathy), CKD (chronic kidney disease) disease), DM (diabetes), and HTN (hypertension). In addition to the comorbidity analysis, the subgroup analysis also evaluated whether the patients had used ACEI/ARB before and different doses of ARNI.
Subgroup Outcomes
1. With or without Comorbidities, patients benefited regardless of prior ACEI/ARB use
observed in subgroup analysis, regardless of CHD, DCM, CKD, DM and HTN, regardless of previous ACEI/ARB use,Sacubitril-valsartan-treated patients had improved EF and NT-proBNP levels< /span> (Figure 5). Among them, the EF value increased by more than 5-8%, and the patients with CKD exceeded 10%; the NT-proBNP level decreased by 37-74% in patients with CKD, DM, CHD, and DCM. Figure 5. EF values (left) and NT-proBNP levels (right) in each subgroup after 6 months of sacubitril-valsartan treatment In terms of renal benefit, CKD subgroup data suggest that sacubitril-valsartan in CKD patients There was no significant effect on the levels of creatinine, serum potassium and glomerular filtration rate, and the overall safety of the patients was good (Figure 6).
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Figure 6. Changes in creatinine, serum potassium and glomerular filtration rate during follow-up in CKD patients
< span>2. In patients with a dose of >200mg/day, the improvement of ejection fraction and NT-proBNP level was more obviousAt the same time, the study also conducted sub-analysis of different doses of ARNI. In group analysis, the results showed that the proportion of patients titrated up to 200 mg and 400 mg gradually increased compared to the initial dose (Figure 7), and 56.6% of patients had dose adjustments during the follow-up period. Figure 7. Changes in the proportion of patients taking different sacubitril-valsartan doses during follow-up
In a subgroup study of drug dose classification, patients in the >200 mg/day group had more significant improvements in the assessment of heart failure (Figure 8). This suggests that titration of sacubitril-valsartan to 200 mg bid can provide more clinical benefit to patients. height
Figure 8. Dose subgroups of patients receiving sacubitril (levovasartan) and EF Changes in NT-proBNP levels (right)
Expert Summary
The prevalence of heart failure increases with age The prevalence of heart failure in my country aged 35-74 is about 0.9%[3]. The publication of the PARADIGM-HF study results in 2014 brought light to patients with chronic heart failure, which showed that ARNI reduced the risk of cardiovascular death by 20% and the risk of heart failure hospitalization by 21% in patients with HFrEF compared with traditional ACEIs[ 4]. In 2017, the approval of sacubitril and valsartan in China promoted the pace of ARNI’s local research in China, and the REALITY-HF China real-world study was launched in the same year. After nearly two years of case collection, the REALITY-HF study finally submitted a satisfactory answer. Studies have shown that sacubitril-valsartan can reduce hospitalization rates, improve cardiac function and NT-proBNP levels, and can benefit regardless of whether patients have comorbidities and whether they have received ACEI/ARB treatment before. In addition, studies suggest that titration of sacubitril and valsartan to a high dose of 200 mg bid as soon as possible can bring more clinical benefit to patients.
Professional Profile
Li Xinli
< strong>Second-level professor, chief physician, doctoral supervisor, Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University
● Nanjing Medical University Famous Doctors
●Young and middle-aged people with outstanding contributions in Jiangsu Province Expert
● Special allowance expert of the State Council
● Vice President of Cardiovascular Branch of Chinese Geriatrics Society
● Chinese Medical Doctor Association Cardiovascular
● Deputy head of the hypertension group of Chinese Cardiovascular Disease Branch
● Vice-chairman of the Collateral Disease Branch of the Chinese Association of Chinese Medicine
● Vice chairman of the Precision Medicine Branch of the Chinese Society of Thoracic and Cardiovascular Anesthesiology
● span> Member of the Standing Committee of Jiangsu Cardiovascular Disease Branch
●Jiangsu Medical Doctor Association Director General of Vascular Disease Branch
Chinese Journal of Cardiovascular Diseases, Chinese Journal of Cardiovascular Diseases, (Online Edition) Chinese Journal of Circulation, Clinical Cardiovascular Diseases Journal, Chinese Journal of Hypertension, Nanjing Medical University and other journal editorial boards.
Presided over six general funds and key projects of the National Natural Science Foundation of China, science and technology Two key projects of the Ministry of Science and Technology, the first prize winner of the National Science and Technology Progress Award To complete one person, two provincial and ministerial first prizes, two second prizes, and publish more than 100 SCI papers as the corresponding author in JACC, Circulation and other journals.
Content planning: Gao Jie
Content review: Xu Chao
The source of the title map: Figure Worm Creative
The source of the illustration: GooooooJ
The source of the picture data: Reference< /span>[2]
Design Supervisor: Huang Gengya
MCC No. EN622043097 Validity 2023 -04-26, the information is expired, it is regarded as invalid.
References:
[1] Writing Committee Members, et al.2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure[J]. J Card Fail . 2022,S1071-9164 (22)00076-8.
[2] REALITY-HF study. Data on file.
[3] Chinese Medical Association Cardiovascular Branch Heart Failure Group, et al. Chinese Heart Failure Diagnosis and Treatment Guidelines 2018[J]. Chinese Journal of Cardiovascular Diseases, 2018,46(10):760-789. p>
[4] McMurray JJV, et al. Baseline characteristics and treatment of patients in prospective comparison of ARNI with ACEI to determine impact on global mortality and morbidity in h eart failure trial (PARADIGM-HF). Eur J Heart Fail[J]. 2014;16(7):817-25.