Department of cardiology, Ain Shams University, Abbassia Square, Cairo, Egypt; Department of cardiology, Dar Al Fouad Hospital, Cairo, Egypt.
Department of cardiology, Ain Shams University, Abbassia Square, Cairo, Egypt; Cardiovascular Institute, Warren Alpert Medical School at Brown University, Providence, Rhode Island.
Am J Cardiol. 2021 Mar 15;143:7-13. doi: 10.1016/j.amjcard.2020.12.037. Epub 2021 Jan 6.
The role of sacubitril and/or valsartan in patient with heart failure (HF) is established. Whether sacubitril and/or 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 and/or valsartan versus ramipril in post-STEMI patients. Patients presenting with STEMI were randomized to receive either sacubitril and/or valsartan or ramipril after primary percutaneous coronary intervention. 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% vs 36%, OR 0.40, 95% 0.22 to 0.75; p = 0.004). At 6 months, LV ejection fraction was higher with sacubitril/valsartan (46.8±12.5% vs 42.09±13.8%; p = 0.012), with improved LV remodelling (LV end diastolic dimension 50.6±3.9 mm vs 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.
沙库巴曲缬沙坦在心力衰竭(HF)患者中的作用已得到确立。沙库巴曲缬沙坦是否在 ST 段抬高型心肌梗死(STEMI)后患者的预后改善方面发挥作用尚不清楚。本研究旨在比较沙库巴曲缬沙坦与雷米普利在 STEMI 后患者中的疗效和安全性。
STEMI 患者在接受直接经皮冠状动脉介入治疗后随机接受沙库巴曲缬沙坦或雷米普利治疗。主要疗效终点为 30 天和 6 个月时的主要不良心脏事件(MACE),定义为心脏死亡、心肌梗死和心力衰竭住院的复合终点。还检查了多个次要临床安全性和疗效终点。
2018 年 1 月至 2019 年 3 月期间共纳入 200 例患者,平均年龄 54.5±10.4 岁,87%为男性,75%为前壁 STEMI。两组间基线临床和超声心动图特征无差异。沙库巴曲缬沙坦组与雷米普利组在 30 天时的 MACE 主要终点相似(p = 0.18);然而,在 6 个月时,沙库巴曲缬沙坦与 MACE 显著降低相关(p = 0.005),主要归因于心力衰竭住院率降低(18% vs 36%,OR 0.40,95%CI 0.22 至 0.75;p = 0.004)。在 6 个月时,沙库巴曲缬沙坦组左心室射血分数更高(46.8±12.5% vs 42.09±13.8%;p = 0.012),左心室重构改善(LV 舒张末期内径 50.6±3.9mm vs 53.2±2.7mm,p = 0.047;LV 收缩末期内径 36.1±3.4mm vs 39.9±6.3mm,p = 0.001),与雷米普利相比。两组在其他疗效或安全性临床终点方面无差异。
综上,STEMI 后早期开始使用沙库巴曲缬沙坦可能为患者带来临床获益和改善心肌重构。