The impact of discontinuation of sacubitril-valsartan and shifting to angiotensin-converting enzyme inhibitor or angiotensin receptor blocker in patients with heart failure with reduced ejection fraction

Objective: Many trials confirmed the role of sacubitril-valsartan in the treatment of patients with heart failure with reduced ejection fraction (HFrEF). However, there is no sufficient data to register the effect of compulsory discontinuation of sacubitril-valsartan, either because of financial shortage or adverse effects, and shifting to the standard therapy, including angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB). Methods: The patients with HFrEF (LVEF <= 35%) were included in the study. They received treatment with sacubitril-valsartan as a replacement for an ACEI or ARB. The patients were divided into two groups: the compliant group (n=111). The non-compliant group (n=82), whose members discontinued sacubitril-valsartan after >= 5 months but <6 months since their enrollment in the study. Results: Initially, 199 patients with HFrEF were included in the study. All the patients were started treatment with sacubitril-valsartan in addition to the evidence-based standard therapy of heart failure. Six patients were excluded at the first follow-up visit (at 6 months). The remaining 193 patients showed initial improvement of the New York Heart Association (NYHA) class, the end-diastolic volume (EDV), and the left ventricular ejection fraction (LVEF). Five patients were excluded at the 12 months' follow-up visit. The other 188 patients were divided into two groups: Group I (n=108) patients were compliant on sacubitril-valsartan for 12 months; Group II (n=80) patients were compliant on sacubitril-valsartan for >= 5 months, but stopped it at <6 months, and were shifted to ACEI or evidence-based ARB. Group II (n=80) patients showed worsening of their NYHA class, compared to the 6 months' follow-up visit (p=0.001). LVEF and EDV were also shown to be worsened in these patients when we compared them to the values of the 6 months' follow-up appointment with p=0.001 for both parameters. Conclusion: The discontinuation of sacubitril-valsartan in patients with HFrEF leads to deterioration of the LVEF as well as worsening of the functional class. The decline in LVEF and NYHA functional class occurs despite being compliant with the optimal conventional therapy with ACEI or evidence-based ARB.