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. All data relevant to the study are included in the article or uploaded as supplementary information.

中文翻译：

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CABG 后早期使用沙库巴曲/缬沙坦

背景心力衰竭（HF）仍然是一个主要的公共卫生问题，在全世界范围内具有很高的死亡率和发病率。目前，尽管有人认为冠状动脉旁路移植术（CABG）在提高生存率方面可能优于药物治疗，但对于缺血性心肌病患者尚无最佳的血运重建策略。然而，CABG 可能与心力衰竭受试者的重大风险相关。因此，我们的目的是评估早期 CABG 后射血分数降低 (HFrEF) 的血流动力学稳定的 HF 患者早期开始使用沙库巴曲/缬沙坦的安全性和有效性。方法 这是一项开放标签研究，其中约 80 名 CABG 后患者被随机分配到早期或晚期开始沙库巴曲-缬沙坦治疗。该研究包括年龄 >40 岁、左心室射血分数 <45% 且 CABG 后早期纽约心脏协会 (NYHA) II-IV 级患者。患者接受干预，起始剂量为沙库巴曲/缬沙坦（24/26 mg 或 49/51 mg，每天两次）。除第一次访视在开始后两周内进行外，随访每 4 周进行一次。主要终点评估关键安全性结果，次要终点为：测量的生活质量、N 端 B 型利钠肽原 (NT-proBNP) 变化和 6 分钟步行测试 (6MWT)。结果 总共筛选了 83 名患者，入组了 77 名患者。大多数患者 (84.4%) 在随机分组时属于 NYHA III 级。两组中止研究的患者人数均较低（2.5%、5.2%），且两组中罕见的肾功能、高钾血症和症状性低血压没有显着差异。两组的生活质量和 6MWT 距离的改善都很显着 (p<0.001)。两组的 NT-proBNP 浓度均下降，与出院后组相比，早期组显着下降 (p<0.001)。结论 CABG 后合并 HFrEF 的患者早期开始使用沙库巴曲/缬沙坦是安全有效的。不良事件和永久停药的发生率较低。随着院内早期开始治疗，NT-proBNP 浓度显着降低。与研究相关的所有数据都包含在文章中或作为补充信息上传。