Short-term efficacy of sacubitril/valsartan in patients with coronary heart disease and heart failure with midrange ejection fraction
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摘要: 目的 探讨冠状动脉旁路移植(CABG)术后应用沙库巴曲缬沙坦对冠心病合并射血分数中间值心力衰竭(HFmrEF)患者心脏功能及重构的影响，并观察其安全性。方法 选取2019年5月—2020年2月在北部战区总医院心血管外科接受CABG的冠心病合并HFmrEF患者136例，根据术后用药情况分为血管紧张素受体脑啡肽酶抑制剂(ARNI)组60例，血管紧张素转换酶抑制剂或血管紧张素Ⅱ受体阻滞剂(ACEI/ARB)组76例。对比分析两组CABG术前及治疗3、6个月后N末端B型钠尿肽前体(NT-proBNP)、左室射血分数(LVEF)、左室舒张末期内径(LVEDD)、左室收缩末期内径(LVESD)、左房内径(LAD)、血尿素氮、血肌酐、血钾及不良心血管事件和不良反应发生情况。结果 CABG术前，两组LVEF、NT-proBNP、LVEDD、LVESD、LAD基线水平比较差异无统计学意义。药物治疗3及6个月，两组LVEF均显著升高(均P < 0.05)；NT-proBNP、LVEDD、LVESD、LAD均显著下降(均P < 0.05)，且ARNI组下降幅度优于ACEI/ARB组(均P < 0.05)。治疗6个月，ACEI/ARB组LVEF较基线水平增加13.30%，ARNI组增加17.39%；ACEI/ARB组NT-proBNP、LVEDD、LVESD、LAD较基线水平分别下降83.36%、10.12%、9.09%、5.12%，ARNI组分别下降89.39%、13.63%、13.21%、12.31%(均P < 0.05)；ACEI/ARB组血肌酐较基线水平增加10.91%(P < 0.05)，ARNI组增加7.12%(P>0.05)。两组患者CABG术前与治疗后血尿素氮、血钾水平以及治疗期间不良心血管事件和不良反应发生率比较，均差异无统计学意义。结论 沙库巴曲缬沙坦较ACEI/ARB更能有效地提高冠心病合并HFmrEF患者CABG术后LVEF，降低血浆NT-proBNP水平，防止心肌损伤，遏制心肌重构，并具有良好的安全性。
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关键词:
- 冠心病 /
- 心力衰竭，射血分数中间值 /
- 冠状动脉旁路移植 /
- 沙库巴曲缬沙坦
Abstract: Objective To investigate the effect of sacubitril/valsartan on cardiac function and remodeling in patients with coronary heart disease and heart failure with midrange ejection fraction(HFmrEF) after coronary artery bypass grafting(CABG) and to observe its safety.Methods A total of 136 patients with coronary heart disease and HFmrEF who received CABG in the Cardiovascular Surgery Department of the Northern Theater General Hospital from May 2019 to February 2020 were selected. They were divided into the angiotensin receptor enkephalinase inhibitor(ARNI) group(n=60) and the angiotensin-converting enzyme inhibitor or angiotensin Ⅱ receptor blocker(ACEI/ARB) group(n=76). The N-terminal precursor B-type natriuretic peptide(NT-proBNP), left ventricular ejection fraction(LVEF), left ventricular end-diastolic diameter(LVEDD), left ventricular end-systolic diameter(LVESD), left atrial diameter(LAD), blood urea nitrogen, serum creatinine, serum potassium, adverse cardiovascular events, and adverse reactions were compared and analyzed before CABG and after 3 and 6 months of treatment.Results Before CABG, there were no significant differences in baseline levels of LVEF, NT-proBNP, LVEDD, LVESD, and LAD between the two groups. After 3 months and 6 months of drug treatment, LVEF in both groups was significantly increased(both P < 0.05); NT-proBNP, LVEDD, LVESD and LAD were significantly decreased(all P < 0.05), and the decline in ARNI group was better than that in ACEI/ARB group(all P < 0.05). After 6 months of treatment, LVEF in ACEI/ARB group increased by 13.30%, and the ARNI group increased by 17.39%; NT-proBNP, LVEDD, LVESD, and LAD in ACEI/ARB group decreased by 83.36%, 10.12%, 9.09%, and 5.12% respectively, and the ARNI group decreased by 89.39%, 13.63%, 13.21%, and 12.31% respectively(all P < 0.05); the serum creatinine in ACEI/ARB group increased by 10.91%(P < 0.05), and the ARNI group increased by 7.12%(P>0.05). There were no significant differences in blood urea nitrogen and potassium levels before CABG and after treatment, adverse cardiovascular events, and adverse reaction incidences between the two groups.Conclusion Sacubitril/valsartan is more effective than ACEI/ARB in improving LVEF, reducing NT-proBNP level, preventing myocardial damage, and curbing myocardial remodeling with good safety in patients with coronary heart disease and HFmrEF after CABG. -
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表 1 两组患者基本资料比较
Table 1. Comparison of baseline data between the two groups
例(%), X±S 项目 ACEI/ARB组(76例) ARNI组(60例) t/χ2值 P值 年龄/岁 63.38±5.46 66.85±5.77 1.583 0.116 男性 44(57.89) 38(63.33) 0.414 0.520 吸烟史 37(48.68) 32(53.33) 0.290 0.590 BMI/(kg·m-2) 23.81±1.62 23.25±2.14 1.692 0.094 陈旧性心肌梗死 32(42.11) 26(43.33) 0.021 0.886 PCI史 20(26.32) 14(23.33) 0.159 0.690 高血压 42(55.26) 35(58.33) 0.129 0.720 糖尿病 27(35.53) 23(38.33) 0.114 0.736 NYHA心功能分级 0.310 0.857 Ⅱ级 26(34.21) 18(30.00) Ⅲ级 36(47.37) 31(51.67) Ⅳ级 14(18.42) 11(18.33) 冠状动脉3支病变 70(92.11) 55(91.67) 0.009 0.926 冠状动脉远端吻合数量/支 3.17±0.60 3.28±0.45 -1.206 0.230 左侧乳内动脉-前降支吻合 66(86.84) 53(88.33) 0.068 0.794 手术时间/min 157.99±31.56 163.40±28.88 -1.031 0.305 体外循环 9(11.84) 7(11.67) 0.001 0.975 PCI：经皮冠状动脉介入治疗；NYHA：纽约心脏病学会。 
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表 2 两组患者心功能指标比较
Table 2. Comparison of cardiac function indexes between the two groups
X±S 组别 LVEF/% NT-proBNP/(ng·L-1) 术前 治疗3个月 治疗6个月 术前 治疗3个月 治疗6个月 ACEI/ARB组(76例) 44.05±3.62 46.36±4.151) 49.91±5.261)2) 854.58±316.73 428.16±256.251) 142.19±28.931)2) ARNI组(60例) 44.40±3.81 47.68±5.191) 52.12±6.281)2) 819.74±284.46 337.37±180.651) 86.94±32.271)2) t值 -0.543 -2.466 -2.705 0.666 2.420 3.735 P值 0.588 0.015 0.008 0.507 0.017 0.000 与同组术前比较，1)P < 0.05；与同组治疗3个月比较，2)P < 0.05。
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表 3 两组患者心脏重构指标比较
Table 3. Comparison of cardiac remodeling indexes between the two groups
X±S 组别 LVEDD/mm LVESD/mm LAD/mm 术前 治疗3个月 治疗6个月 术前 治疗3个月 治疗6个月 术前 治疗3个月 治疗6个月 ACEI/ARB组(76例) 54.92± 5.35 51.76± 5.061) 49.36± 6.221)2) 45.33± 4.59 42.54± 5.371) 41.21± 5.081)2) 38.67± 4.91 37.42± 4.80 36.69± 4.761) ARNI组(60例) 54.22± 6.12 49.32± 6.591) 46.83± 8.581)2) 45.57± 5.05 41.27± 4.581) 39.55± 4.531)2) 39.06± 5.94 36.58± 5.531) 34.25± 6.211)2) t值 0.715 2.448 2.616 -0.068 2.375 2.010 -0.353 0.945 2.325 P值 0.476 0.016 0.010 0.946 0.019 0.046 0.724 0.346 0.022 与同组术前比较，1)P < 0.05；与同组治疗3个月比较，2)P < 0.05。
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表 4 两组患者肾功能及血钾水平的比较
Table 4. Comparison of renal function and serum potassium levels between the two groups
X±S 组别 尿素氮/(mmol·L-1) 肌酐/(μmol·L-1) 钾/(mmol·L-1) 术前 治疗3个月 治疗6个月 术前 治疗3个月 治疗6个月 术前 治疗3个月 治疗6个月 ACEI/ARB组(76例) 4.58± 1.04 4.42± 1.24 4.44± 1.28 72.02± 22.17 74.12± 20.35 79.88± 22.211) 4.31± 0.35 4.34± 0.41 4.28± 0.43 ARNI组(60例) 4.23± 1.35 4.29± 1.63 4.02± 1.81 69.25± 23.98 71.78± 25.80 74.18± 24.69 4.27± 0.42 4.31± 0.37 4.32± 0.35 t值 1.717 0.513 1.590 0.712 0.199 1.531 0.538 0.372 -0.412 P值 0.088 0.609 0.114 0.478 0.842 0.128 0.592 0.710 0.681 与同组术前比较，1)P < 0.05。
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[1] Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology(ESC). Developed with the special contribution of the Heart Failure Association(HFA)of the ESC[J]. Eur J Heart Fail, 2016, 18(8): 891-975. doi: 10.1002/ejhf.592
[2] 王华, 李莹莹, 柴坷, 等. 中国住院心力衰竭患者流行病学及治疗现状[J]. 中华心血管病杂志, 2019, 47(11): 865-874.
[3] Sun LY, Gaudino M, Chen RJ, et al. Long-term outcomes in patients with severely reduced left ventricular ejection fraction undergoing percutaneous coronary intervention vs coronary artery bypass grafting[J]. JAMA Cardiol, 2020, 5(6): 631-641. doi: 10.1001/jamacardio.2020.0239
[4] McDonagh TA, Metra M, Adamo M, et al. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure[J]. Eur Heart J, 2021, 42(36): 3599-3726. doi: 10.1093/eurheartj/ehab368
[5] Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines[J]. Circulation, 2022, 145(18): e895-e1032.
[6] 王华, 梁延春. 中国心力衰竭诊断和治疗指南2018[J]. 中华心血管病杂志, 2018, 46(10): 760-789. https://www.cnki.com.cn/Article/CJFDTOTAL-ZLYS201904009.htm
[7] 中国冠状动脉旁路移植术后二级预防专家共识组, 中国医师协会心血管医师分会冠心病外科学组, 中华医学会胸心血管外科学分会冠心病外科学组. 中国冠状动脉旁路移植术后二级预防专家共识(2020版)[J]. 中华胸心血管外科杂志, 2021, 37(4): 193-201.
[8] Bragazzi NL, Zhong W, Shu J, et al. Burden of heart failure and underlying causes in 195 countries and territories from 1990 to 2017[J]. Eur J Prev Cardiol, 2021, 28(15): 1682-1690. doi: 10.1093/eurjpc/zwaa147
[9] Ibrahim NE, Song Y, Cannon CP, et al. Heart failure with mid-range ejection fraction: characterization of patients from the PINNACLE Registry(R)[J]. ESC Heart Fail, 2019, 6(4): 784-792. doi: 10.1002/ehf2.12455
[10] Deo SV, Sundaram V, Sahadevan J, et al. Outcomes of coronary artery bypass grafting in patients with heart failure with a midrange ejection fraction[J]. J Thorac Cardiovasc Surg, 2021, 10.1016/j. jtcvs. 2021.01.035.
[11] Tsuji K, Sakata Y, Nochioka K, et al. Characterization of heart failure patients with mid-range left ventricular ejection fraction-a report from the CHART-2 Study[J]. Eur J Heart Fail, 2017, 19(10): 1258-1269. doi: 10.1002/ejhf.807
[12] McMurray JJ, Packer M, Desai AS, et al. Angiotensin-neprilysin inhibition versus enalapril in heart failure[J]. N Engl J Med, 2014, 371(11): 993-1004. doi: 10.1056/NEJMoa1409077
[13] 周永越, 徐兆龙. 沙库巴曲缬沙坦对射血分数中间值心力衰竭患者的预后影响[J]. 临床心血管病杂志, 2021, 37(2): 132-136. https://www.cnki.com.cn/Article/CJFDTOTAL-LCXB202102009.htm
[14] 任伟豪, 张艺舰, 卜泽, 等. 术前心力衰竭程度与非体外循环冠状动脉旁路移植术后远期预后关系研究[J]. 临床军医杂志, 2021, 49(8): 852-856. https://www.cnki.com.cn/Article/CJFDTOTAL-JYGZ202108005.htm
[15] Chen W, Liu Y, Li Y, et al. Sacubitril/valsartan improves cardiac function in Chinese patients with heart failure: a real-world study[J]. ESC Heart Failure, 2021, 8(5): 3783-3790.
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