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Published on: June 12, 2021
Use of sacubitril/valsartan early after CABG
Madina Nurzhanova1,2, Aisulu Musagaliyeva1, Raushan Zhakypova1
1Scientific Research Institute of Cardiology and Internal Diseases, Almaty, Kazakhstan.
Insights
Early sacubitril/valsartan initiation after coronary artery bypass grafting (CABG) in heart failure with reduced ejection fraction (HFrEF) patients is safe and effective. This approach significantly reduced NT-proBNP levels, improving quality of life and exercise capacity.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Medicine
Background:
- Heart failure (HF) significantly impacts global public health.
- Coronary artery bypass grafting (CABG) may improve survival in ischaemic cardiomyopathy but carries risks.
- Optimal revascularisation strategies for HF patients remain under investigation.
Purpose of the Study:
- To evaluate the safety and efficacy of early sacubitril/valsartan initiation in stable HF with reduced ejection fraction (HFrEF) patients post-CABG.
- To assess adverse events, quality of life, NT-proBNP levels, and 6-minute walk test (6MWT) performance.
Main Methods:
- Open-label, randomized study of approximately 80 HFrEF patients after CABG.
- Patients randomized to early or late sacubitril/valsartan initiation.
- Primary endpoint: safety outcomes. Secondary endpoints: quality of life, NT-proBNP, and 6MWT.
Main Results:
- 77 patients enrolled; low discontinuation rates (2.5-5.2%).
- No significant differences in renal function, hyperkalaemia, or hypotension between groups.
- Significant improvements in quality of life and 6MWT distance (p<0.001).
- NT-proBNP levels decreased significantly, particularly in the early initiation group (p<0.001).
Conclusions:
- Early sacubitril/valsartan initiation in post-CABG HFrEF patients is safe and effective.
- Low incidence of adverse events and permanent discontinuation observed.
- Significant reduction in NT-proBNP levels supports early in-hospital initiation.
Background:
Heart failure (HF) remains a major public health problem with a high mortality and morbidity worldwide. Currently, there is no optimal revascularisation strategy for patients with ischaemic cardiomyopathy despite suggestions that coronary artery bypass graft (CABG) may be superior to medical therapy in improving survival. However, CABG may be associated with substantial risk in HF subjects. We therefore aimed to evaluate the safety and efficacy of the early initiation of sacubitril/valsartan in haemodynamically stabilised patients with HF with reduced ejection fraction (HFrEF) after early CABG.
Methods:
This was an open-label study in which ~80 patients after CABG were randomised either to the early or late initiation of the sacubitril-valsartan. The study included patients >40 years with left ventricular ejection fraction <45% and New York Heart Association (NYHA) class II-IV at the early stage after CABG. Patients underwent intervention, the starting dose of sacubitril/valsartan (24/26 mg or 49/51 mg two times per day). The follow-up took place every 4 weeks except the first visit, which took place in 2 weeks after initiation. The primary endpoint assessed the key safety outcomes, the secondary endpoints were: the quality of life measured, the N-terminal pro-B-type natriuretic peptide (NT-proBNP) changes and 6 min walk test (6MWT).
Results:
In total, 83 patients were screened and 77 patients were enrolled. The majority of patients (84.4%) were in the NYHA class III at randomisation. The number of patients who discontinued the study was low in both groups (2.5%, 5.2%), and renal function, hyperkalaemia and symptomatic hypotension rarely seen in both groups did not differ significantly. The improvement in quality of life and distance at the 6MWT in both groups was significant (p<0.001). The NT-proBNP concentration decreased in both groups, the significant reduction was in the early group (p<0.001) versus the postdischarge group.
Conclusions:
The early initiation of sacubitril/valsartan in patients after CABG with HFrEF is safe and effective. Adverse events and permanent discontinuation were low. The NT-proBNP concentration reduced significantly with the early in-hospital initiation.
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