| Background: Acute anterior ST elevation myocardial infarction(STEMI)is a serious type of coronary heart disease and the main cause of death and disability.Even with the advent of coronary intervention techniques and progress in medication,acute myocardial infarction(AMI)remains the main cause of death from coronary artery disease.Preventing,slowing down or reversing cardiac remodeling is the main treatment goal for reducing the risk of heart failure and other cardiovascular events after acute myocardial infarction.Sacubitril/Valsartan is a new single-molecule composed of valsartan and NEP inhibitor prodrug sacubitril(1:1 ratio).Previous clinical trials were confirmed that sacubitril/valsartan was superior to ACEI in improving cardiac structural and functional parameters and reducing the risk of heart failure rehospitalization and cardiovascular death in heart failure patients with reduced ejection fraction.However,there is little data describing the effects of sacubitril/valsartan in patients with acute anterior ST-segment elevation myocardial infarction(STEMI).Therefore,we initiated this study to evaluate the safety and effectiveness of immediate initiation of sacubitril/valsartan in patients with acute anterior STEMI after PCI.Methods: In this single-center,prospective,randomized trial,STEMI subjects who treated with emergency percutaneous coronary intervention(PCI)were enrolled.Within 24 hours after PCI,the patients were randomly divided into sacubitril/valsartan(Experimental)and enalapril(control)groups 1:1 using software-based random functions.Patients randomized to enalapril group continue to receive enalapril,and patients randomized to the sacubitril/valsartan group began to receive sacubitril/valsartan after a 36-hour washout period.A total of 128 patients were randomly divided into two groups to receive sacubitril/valsartan or enalapril,both groups were received standard STEMI management.A dose titration algorithm was used to select the initial dose at the beginning of hospitalization and subsequent dose changes during the drug titration.The primary efficacy outcomes were the changes in NT-pro BNP concentrations from baseline through weeks 4,12 and 24 and echocardiographic parameters(left ventricular ejection fraction(LVEF),left ventricular end-diastolic volumes(LVEDV),left ventricular end-systolic volumes(LVESV))from baseline through weeks 12 and 24.Secondary outcomes were the composite of death,reinfarction,outpatient HF or HF hospitalization,arrhythmia,and stroke.Safety outcomes were the incidence of worsening renal function,hypotension,hyperkalemia,angioedema and cough.Results: The NT-pro BNP level was significantly reduced in both two groups from the baseline to the week 24.However,The NT-pro BNP concentration was decreased more in the sacubitril/valsartan group than in the enalapril group at 4 weeks(279(236-331)pg/ml VS 671(542-831)pg/ml;P=0.015).patients assigned to the sacubitril/valsartan group had a significant reduction in LVEDV(114.4±21.31 ml VS129.3±19.00ml;P<0.001),a reduction in LVESV(55.3±18.77 ml VS 64.2±16.00ml;P<0.001)and an improvement in LVEF(51.8±8.84% VS 50.6±8.52%;P=0.012)at 24 weeks.Secondary outcomes occurred in 13 patients(20.31%)in the sacubitril/valsartan group and 22 patients(34.38%)in the enalapril group(hazard ratio[HR],0.56;(95% [Confidence Interval,CI],0.28 to 1.12;P=0.102).The incidence of outpatient HF or HF hospitalization in the sacubitril/valsartan group was significantly lower than that in the enalapril group(HR,0.36;95% CI,0.14 to 0.94;P=0.037).There were no significant differences in the safety between the two groups.Conclusions: In patients with acute anterior STEMI undergoing emergency PCI,sacubitril/valsartan decreased NT-pro BNP level,improved the systolic function of the left ventricle,and reduced the incidence of outpatient heart failure or heart failure hospitalization,regardless of whether the patients exhibited symptoms or signs of heart failure when sacubitril/valsartan was initiated. |
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