| Objective:In this study,we aim to observe the clinical efficacy of sacubitril/valsartan in acute myocardial infarction patients with cardiac insufficiency undergoing percutaneous coronary intervention(PCI),as well as the incidence of adverse reactions and major Adverse Cardiovascular Events(MACE),so that we investigate the specific effect of sacubitril/valsartan in myocardial infarction patients with heart failure undergoing PCI.Methods:According to the strict inclusion and exclusion criteria,a total of 202 acute myocardial infarction patients with cardiac insufficiency who underwent PCI at in the Affiliated Hospital of Qingdao University were involved in this study.The patients were randomly divided into two groups by random number table method.In the observation group(n=104)were treated with sacubitril/valsartan based on the routine treatment,while the control group(n = 98)was treated with valsartan based on the routine treatment.The two groups could be further divided into myocardial infarction with preserved ejection fraction group,myocardial infarction with reserved ejection fraction group according to the ejection fraction.The patients with median ejection fraction were arranged into the myocardial infarction with preserved ejection fraction group.The N-terminal B-type natriuretic peptide(NT-proBNP)in serum,left ventricular ejection fraction(LVEF)and left ventricular enddiastolic diameter(LVEDD),as well as 6 minutes walking test(6MWT),were used as indexes to access the efficacy between the two groups in 3 months and 6 months after surgery.In addition,the clinical effective rate at 6 months after operation,the cases of adverse reactions and MACE were compared between the two groups.Results:In the observation group,1 patient developed complication of severe hypotension and another developed complication of severe dry cough who were excluded from the study,and finally 102 patients were enrolled in the study.23% of patients in the observation group received sacubitril/valsartan 50 mg twice a day;64% received 100 mg twice a day,and 13%received 200 mg twice a day,while 77% of patients in the control group received valsartan80 mg once a day,and 23% received valsartan 160 mg once a day.1.The NT-proBNP at 3 months and 6 months after operation were significantly decreased than that before discharge both in the observation group and the control group,and it was significantly lower in the observation group compared to that in the control group.There was a further decline at 6 months compared with 3 months after operation(P<0.01)both in the two groups.2.The LVEF at 3 months and 6 months after operation were significantly increased than that before discharge both in the observation group and the control group,and it was significantly higher in the observation group compared to that in the control group.There was a further rise at 6 months compared with 3 months after operation(P<0.01)both in the two groups.3.The LVDD,a cardiac ultrasound indicator,were significantly minished at 3 months and 6 months after operation than that before discharge both in the two groups,and it was significantly declined in the observation group compared to that in the control group.There was a further decline at 6 months compared with 3 months after operation(P<0.01)both in the two groups.4.In the observation group,the results of 6MWT at 3 months and 6 months after operation were better than that in the control group respectively.And the results of 6MWT at 6 months s after operation were better than that at 3 months s after operation in both the observation and control groups.5.Among the patients with marked efficacy,patients with efficacy in the observation group was significantly more than that of control group(P<0.01),however,there was no difference of invalid cases between the two groups(P > 0.05).Compared with the control group,patients with hypotension were more in the observation group,although there was no statistical difference(P > 0.05).The cases of adverse reaction and MACE were not increased in the observation group.6.The results of analysis within each subgroup were as follows:6.1 In the observation group,there was statistical significance of NT-proBNP,LVEF and LVEDD between the subgroup with preserved ejection fraction and the subgroup with reduced ejection fraction(P < 0.01).6.2 In the subgroup with preserved ejection fraction from the control group,NTproBNP in serum decreased with the extension of treatment time with statistical significance(P < 0.01).LVEF at 3 months after operation were higher than that before discharge without statistical significance(P=0.094).It is the same when compared LVEF at 6 months with that at 3 months after surgery(P=0.115),only the difference at 6 months after surgery compared with that before discharge was statistically significant(P < 0.01).LVEDD at 3 months after operation were decreased than that before discharge without statistical significance(P=0.068).It is the same when compared LVEDD at 6 months with that at 3 months after surgery(P=0.778),only the difference at 6 months after surgery compared with that before discharge was statistically significant(P < 0.01).6.3 In the subgroup with reduced ejection fraction from the control group,difference of the NT-proBNP,LVEF between groups showed statistical significance(P < 0.01).The LVEDD at 6 months after surgery were decreased with that before discharge and 3 months after surgery respectively(P < 0.05),while LVEDD at 3 months after surgery were lower than that before discharge without statistical significance(P=0.068).6.4 The results of 6MWT at 6 months s after operation were better than that at 3months s after operation in both the observation subgroup and control subgroup(P<0.05).6.5 In the observation group,there were no significant differences of NT-proBNP,LVEDD and 6MWT distance between the subgroup with preserved ejection fraction and the subgroup with reduced ejection fraction(P > 0.05).The LVEF in the subgroup with reduced ejection fraction was lower than that in the subgroup with preserved ejection fraction with statistical significance(P < 0.01).The results of the two subgroups in the control group were consistent with those in the observation group.Conclusion:The efficacy of sacubitril/valsartan in acute myocardial infarction patients with cardiac dysfunction undergoing PCI was better than that of valsartan no matter in the preserved ejection fraction group or the reduced group.The sacubitril/valsartan could improve patients’ condition significantly,reverse ventricular remodeling and improve the clinical prognosis of patients effectively without an increase in adverse reactions. |
PDF Full Text Request