Comparison of the Efficacy and Safety of Sacubitril/Valsartan versus Ramipril in Patients with ST-Segment Elevation Myocardial Infarction.
The role of sacubitril/valsartan in patient with heart failure (HF) is established. Whether sacubitril/valsartan plays a role in improving outcomes in patients after ST-segment elevation myocardial infarction (STEMI) is unknown. The current study aims to comparing the efficacy and safety of sacubitril/valsartan versus ramipril in post-STEMI patients. Patients presenting with STEMI were randomized to receive either sacubitril/valsartan or ramipril after primary percutaneous coronary intervention (PCI). The main efficacy endpoint was major adverse cardiac events (MACE) at 30 days and 6 months, defined as a composite of cardiac death, myocardial infarction, and HF hospitalizations. Multiple secondary clinical safety and efficacy endpoints were examined. A total of 200 patients were randomized from January 2018 to March 2019, mean age 54.5±10.4, 87% men, 75% presented with anterior wall STEMI. Baseline clinical and echocardiographic characteristics were comparable between groups. The primary endpoint of MACE was similar with sacubitril/valsartan versus ramipril at 30 days (p=0.18); however, at 6 months, sacubitril/valsartan was associated with significant reduction of MACE (p=0.005), mainly driven by reduction in HF hospitalizations (18% versus 36%, OR 0.40, 95% 0.22-0.75; p=0.004). At 6 months, LV ejection fraction was higher with sacubitril/valsartan (46.8±12.5% versus 42.09±13.8%; p=0.012), with improved LV remodelling (LV end diastolic dimension 50.6±3.9 mm versus 53.2±2.7 mm, p=0.047; and LV end systolic dimension 36.1±3.4 mm versus 39.9±6.3 mm, p=0.001) compared with ramipril. No difference in other efficacy or safety clinical endpoints was observed. In conclusion, early initiation of sacubitril/valsartan may offer clinical benefit and improvement in myocardial remodelling in post-STEMI patients.