Centro Cardiologico Monzino, IRCCS, Heart Failure Unit.
Cardiovascular Section, Department of Clinical Sciences and Community Health, University of Milan, Milan.
J Cardiovasc Med (Hagerstown). 2020 Nov;21(11):882-888. doi: 10.2459/JCM.0000000000001018.
Practice guidelines recommend sacubitril/valsartan for heart failure with reduced ejection fraction. The aim of our study was to describe the use of sacubitril/valsartan in real-world clinical practice to help identify patients best able to tolerate titration to higher doses.
We retrospectively analyzed clinical data for 201 patients with heart failure with reduced ejection fraction prescribed sacubitril/valsartan at our heart failure clinic (Centro Cardiologico Monzino) between September 2016/December 2018. Patients had a mean age of 67.2 years, mean left ventricular ejection fraction of 30.1%, New York Heart Association class II (65%), class III (35%), and poor cardiopulmonary exercise capacity. Median 2-year risk of death/urgent cardiac transplantation was 8.9% [Metabolic Exercise Cardiac Kidney Index (MECKI) score].
After a median follow-up of 230 (interquartile interval: 105-366) days, 57 patients achieved higher-dose sacubitril/valsartan, 103 tolerated medium/low doses, nine died, and 20 interrupted treatment. The highest dose of sacubitril/valsartan was reached by younger patients with better hemoglobin (Hb) levels, renal function, and blood pressure (BP). Patients continuing on sacubitril/valsartan had significantly higher serum Hb and sodium, better BP, and lower MECKI scores than patients who discontinued treatment or died during follow-up. Our patients were older and frailer than those in the pivotal PARADIGM-HF trial.
In our experience, more than one-third of the patients were able to tolerate the higher dose of sacubitril/valsartan, and these patients were younger, had higher Hb, and better BP and renal function. MECKI score stratification was useful to discriminate patients who continued treatment from those who did not. Future prospective studies should test if these clinical variables can guide the up-titration of sacubitril/valsartan.
临床实践指南推荐沙库巴曲缬沙坦用于射血分数降低的心力衰竭。本研究旨在描述沙库巴曲缬沙坦在真实世界临床实践中的应用，以帮助确定最能耐受滴定至高剂量的患者。
我们回顾性分析了 201 例 2016 年 9 月至 2018 年 12 月在我院心力衰竭门诊（Centro Cardiologico Monzino）接受沙库巴曲缬沙坦治疗的射血分数降低的心力衰竭患者的临床资料。患者平均年龄 67.2 岁，平均左心室射血分数 30.1%，纽约心脏协会（NYHA）心功能分级 II 级（65%）、III 级（35%），心肺运动能力差。中位 2 年死亡/紧急心脏移植风险为 8.9%（代谢运动心脏肾脏指数（MECKI）评分）。
中位随访 230（四分位间距：105-366）天后，57 例患者达到沙库巴曲缬沙坦高剂量，103 例患者耐受中低剂量，9 例患者死亡，20 例患者中断治疗。达到沙库巴曲缬沙坦最高剂量的患者年龄较小，血红蛋白（Hb）水平、肾功能和血压（BP）较好。继续使用沙库巴曲缬沙坦的患者血清 Hb 和钠水平较高，BP 较好，MECKI 评分较低，与随访期间停止治疗或死亡的患者相比差异有统计学意义。我们的患者比关键性 PARADIGM-HF 试验中的患者年龄更大，身体更虚弱。
在我们的经验中，超过三分之一的患者能够耐受沙库巴曲缬沙坦的高剂量，这些患者年龄较小，Hb 水平较高，BP 和肾功能较好。MECKI 评分分层有助于区分继续治疗的患者和未继续治疗的患者。未来的前瞻性研究应检验这些临床变量是否可以指导沙库巴曲缬沙坦的滴定。
