Clinical study of sacubitril valsartan in the treatment of patients with heart failure of midrange ejection fraction after acute myocardial infarction

doi:10.11958/20230587

Abstract

Abstract:

Objective To investigate the efficacy and safety of sacubitril valsartan in the treatment of heart failure (HF) of midrange ejection fraction（HFmrEF）in patients after acute myocardial infarction (AMI). Methods A total of 102 patients with HFmrEF after AMI were divided into the control group and the experimental group, with 51 cases in each group. The control group was given conventional treatment for AMI and anti-HF treatment, and the angiotensin-converting enzyme inhibitor (ACEI)/ angiotensin Ⅱ receptor blocker (ARB) was used without contraindications. The experimental group was replaced by ACEI/ARB with sacubitril valsartan on the basis of the control group. After 6 months of treatment, the total effective rates of the two groups after treatment were analyzed, and the cardiac function, N-terminal pro-brain natriuretic peptide (NT-proBNP) and serum inflammatory factor C-reactive protein (CRP) were compared before and after treatment. The occurrence of adverse reactions after treatment was recorded. Kaplan-Meier method was used to analyze the cumulative cardiovascular mortality, HF rehospitalization rate and end-event-free survival after 6 months of treatment in two groups. Results After treatment, there was no significant difference in the occurrence of adverse reactions between the two groups (P>0.05). The total effective rate was higher in the experimental group than that of the control group (P<0.05). Compared with before treatment, left ventricular ejection fraction (LVEF), stroke volume (SV), mitral diastolic blood flow velocity E peak and A peak ratio (E/A) and 6 min walking distance (6MWD) were increased in the two groups, and left ventricular end-diastolic diameter (LVEDD) and left atrial diameter (LAD) were decreased in the two groups after treatment (all P<0.05). After treatment, LVEF, SV, E/A and 6MWD were higher in the experimental group than those in the control group (P<0.05). LVEDD and LAD were lower than those in the control group (all P<0.05). Compared with results before treatment, NT-proBNP and CRP were decreased after treatment in the experiment group than those in the control group (P<0.05). There was no significant difference in the cumulative cardiovascular mortality between the experiment group and the control group (3.9% vs. 5.9%，P=0.524). The cumulative HF rehospitalization rate was lower in the experimental group than that of the control group (9.8% vs. 23.5%，P=0.042). The cumulative end-point-free survival rate was higher in the experiment group than that of the control group (86.3% vs. 70.6%, P=0.037). Conclusion Sacubitril valsartan is safer and more effective than ACEI/ARB in the treatment of AMI patients with HFmrEF, and it is worthy of clinical promotion.

Key words: myocardial infarction, acute disease, heart failure, drug evaluation, sacubitril valsartan, curative effect

CLC Number:

R541.6

Figures/Tables 6

Tab.1 Comparison of baseline data between the two groups

组别	性别（男/女）	年龄/岁	BMI/ （kg/m²）	再灌注策略（PCI/静脉溶栓）	NYHA心功能分级（Ⅱ级/Ⅲ级/Ⅳ级）	既往史
组别	性别（男/女）	年龄/岁	BMI/ （kg/m²）	再灌注策略（PCI/静脉溶栓）	NYHA心功能分级（Ⅱ级/Ⅲ级/Ⅳ级）	糖尿病	高血压	心房颤动	吸烟	饮酒
对照组	31/20	72.88 $±$ 10.10	22.58 $±$ 3.02	47/4	6/13/32	18（35.3）	28（54.9）	18（35.3）	15（29.4）	5（9.8）
试验组	30/21	69.35 $±$ 11.92	23.79 $±$ 3.44	46/5	5/14/32	21（41.2）	35（68.6）	14（27.5）	18（35.3）	7（13.7）
χ²或t	0.840	1.614	1.890	0.122	0.128	0.374	2.034	0.729	0.403	0.378

Tab.1 Comparison of baseline data between the two groups

组别	性别（男/女）	年龄/岁	BMI/ （kg/m²）	再灌注策略（PCI/静脉溶栓）	NYHA心功能分级（Ⅱ级/Ⅲ级/Ⅳ级）	既往史
组别	性别（男/女）	年龄/岁	BMI/ （kg/m²）	再灌注策略（PCI/静脉溶栓）	NYHA心功能分级（Ⅱ级/Ⅲ级/Ⅳ级）	糖尿病	高血压	心房颤动	吸烟	饮酒
对照组	31/20	72.88 $±$ 10.10	22.58 $±$ 3.02	47/4	6/13/32	18（35.3）	28（54.9）	18（35.3）	15（29.4）	5（9.8）
试验组	30/21	69.35 $±$ 11.92	23.79 $±$ 3.44	46/5	5/14/32	21（41.2）	35（68.6）	14（27.5）	18（35.3）	7（13.7）
χ²或t	0.840	1.614	1.890	0.122	0.128	0.374	2.034	0.729	0.403	0.378

Tab.2 Comparison of general data before treatment between the two groups

组别	n		收缩压/mmHg		舒张压/mmHg	HR/（次/min）		Scr/（μmol/L）			Hb/（g/L）	PLT/（×10⁹/L）
对照组	51		134.76±18.16		84.55±10.96	78.61±17.04		84.75±23.66			131.04±17.09	232.90±61.10
试验组	51		140.29±22.32		87.84±10.94	75.92±15.77		88.82±22.72			136.06±18.96	229.22±69.13
t			1.373		1.519	0.826		0.888			1.404	0.285
组别		用药情况
组别		降血脂药		抗血小板聚集药			硝酸酯类		利尿剂	β受体阻滞药			地高辛
对照组		45（88.2）		42（82.4）			42（82.4）		43（84.3）	42（82.4）			10（19.6）
试验组		49（96.1）		40（78.4）			38（74.5）		47（92.2）	47（92.2）			11（21.6）
χ²		2.170		0.249			0.927		1.511	2.204			0.060

Tab.3 Results of hospitalization and follow-up data of the two groups

组别	n	因HF再住院	住院时间/d	不良反应	疗效
组别	n	因HF再住院	住院时间/d	不良反应	显效	有效	无效	总有效
对照组	46	12（26.1）	11.48±2.34	4（8.7）	13（28.3）	26（56.5）	7（15.2）	39（84.8）
试验组	47	5（10.6）	8.94±1.95	4（8.5）	22（46.8）	24（51.1）	1（2.1）	46（97.9）
t、Z或χ²		3.714	5.703^＊＊	0.001		2.346^＊		5.066^＊

Tab.4 Comparison of cardiac function indexes before and after treatment between the two groups

组别	n			LVEF									SV/mL
组别	n			治疗前			治疗后			t			治疗前			治疗后			t
对照组	46			0.444±0.025			0.480±0.060			4.289^＊＊			59.89±19.29			73.63±12.09			6.177^＊＊
试验组	47			0.442±0.024			0.520±0.050			11.785^＊＊			66.96±19.34			85.13±8.07			6.576^＊＊
t				0.398			3.479^＊＊						1.764			5.383^＊＊
组别			LAD/mm									LVEDD/mm
组别			治疗前		治疗后			t				治疗前		治疗后			t
对照组			43.24±7.79		42.30±7.58			7.924^＊＊				57.28±8.42		51.57±6.00			5.786^＊＊
试验组			44.51±6.87		39.15±3.93			10.800^＊＊				58.74±8.83		46.30±6.43			14.172^＊＊
t			0.835		2.512^＊							0.817		4.084^＊＊
组别		E/A									6MWD/m
组别		治疗前				治疗后			t		治疗前				治疗后			t
对照组		0.81±0.23				1.16±0.28			9.037^＊＊		336.80±133.76				395.59±127.23			3.541^＊＊
试验组		0.83±0.25				1.37±0.15			16.741^＊＊		334.06±101.91				465.74±111.28			8.408^＊＊
t		0.466				4.435^＊＊					0.111				2.832^＊

Tab.5 Comparison of CRP and NT-proBNP before and after treatment between the two groups

组别		n	CRP/（mg/L）
组别		n	治疗前		治疗后	t
对照组		46	15.76±6.59		8.68±3.91	9.314^＊＊
试验组		47	15.65±8.36		6.36±3.50	9.448^＊＊
t			0.066		3.015^＊＊
组别	NT-proBNP/（ng/L）
组别	治疗前			治疗后			Z
对照组	2 086.5（1 141.5，4 209.5）			605.5（523.8，1 079.3）			5.905^＊＊
试验组	2 880.0（1 353.0，3 711.0）			527.0（437.0，798.0）			5.968^＊＊
Z	1.014			2.601^＊

Fig.1 Survival curves of the two groups

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