Department of Cardiology, Faculty of Medicine, Beni-Suef University; Beni-Suef-Egypt.
Department of Cardiology, Faculty of Medicine, Tanta University; Tanta-Egypt.
Anatol J Cardiol. 2021 Mar;25(3):163-169. doi: 10.14744/AnatolJCardiol.2020.39267.
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 finan-cial shortage or adverse effects, and shifting to the standard therapy, including angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB).
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.
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.
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.
许多试验证实沙库巴曲缬沙坦在射血分数降低的心力衰竭（HFrEF）患者治疗中的作用。然而，由于财务短缺或不良反应，没有足够的数据来证实强制停用沙库巴曲缬沙坦的效果，转而采用标准治疗，包括血管紧张素转换酶抑制剂（ACEI）或血管紧张素受体阻滞剂（ARB）。
将 HFrEF（LVEF≤35%）患者纳入研究。他们接受沙库巴曲缬沙坦治疗，替代 ACEI 或 ARB。患者分为两组：依从组（n=111）。非依从组（n=82），其成员在入组后≥5 个月但<6 个月停止使用沙库巴曲缬沙坦。
最初，199 例 HFrEF 患者纳入研究。所有患者均在心力衰竭的循证标准治疗基础上加用沙库巴曲缬沙坦治疗。第 1 次随访（6 个月时）排除 6 例患者。其余 193 例患者心功能纽约心脏协会（NYHA）分级、舒张末期容积（EDV）和左心室射血分数（LVEF）均有初始改善。第 12 个月随访时排除 5 例患者。其余 188 例患者分为两组：I 组（n=108）患者沙库巴曲缬沙坦治疗 12 个月；II 组（n=80）患者沙库巴曲缬沙坦治疗≥5 个月，但在<6 个月时停药，改用 ACEI 或循证 ARB。与 6 个月随访时相比，II 组（n=80）患者 NYHA 分级恶化（p=0.001）。与 6 个月随访时相比，这些患者的 LVEF 和 EDV 也恶化（p=0.001）。
在 HFrEF 患者中停用沙库巴曲缬沙坦会导致 LVEF 恶化和功能分级恶化。尽管依从性较好，接受 ACEI 或循证 ARB 的最佳常规治疗，但 LVEF 和 NYHA 功能分级仍会下降。
