恩格列净对行直接经皮冠状动脉介入治疗的 ST 段抬高型心肌梗死患者的影响：EMI-STEMI 随机临床试验。
Empagliflozin Effects in Patients with ST-Elevation Myocardial Infarction Undergoing Primary PCI: The EMI-STEMI Randomized Clinical Trial.
机构信息
Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.
Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
出版信息
Am J Cardiovasc Drugs. 2024 Sep;24(5):673-684. doi: 10.1007/s40256-024-00662-4. Epub 2024 Jul 5.
INTRODUCTION
Empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, improves cardiovascular outcomes in heart failure patients, but data regarding the efficacy of empagliflozin in the setting of acute myocardial infarction (AMI) is still unclear. The current study aimed to evaluate whether treatment with empagliflozin before primary percutaneous coronary intervention (PCI) improves parameters associated with patients' outcomes.
METHODS
We randomly assigned 101 non-diabetic and non-heart failure patients with ST-elevation myocardial infarction (STEMI) who underwent primary PCI to receive either empagliflozin (10 mg before PCI and once daily for 40 days) or placebo, in addition to the standard treatment. The primary outcomes were changes in left ventricular ejection fraction (LVEF) 40 days after PCI, changes in cardiac troponin I (cTnI) and estimates of its area under the curve (AUC) and the peak level, and resolution of ST-segment in > 50% of leads 90 min after PCI.
RESULTS
No significant difference was observed in terms of the occurrence of ST-segment resolution > 50% (46.0% versus 45.0%; p = 0.92) and the mean level of cTnI at each time point between the two groups. The estimated mean [standard deviation (SD)] AUC of cTnI was 955.0 (595.7) ng h/ml in the intervention and 999.7 (474.7) ng h/ml in the control groups (p = 0.85) without any significant difference in peak cTnI level. The mean (SD) LVEF 40 days after primary PCI was significantly higher in empagliflozin-treated patients than the placebo group [43.2% (5.8%) versus 39.2% (6.7%); p = 0.002].
CONCLUSION
In this study, no significant differences were observed across the groups in terms of cTnI levels and ST-segment resolution in patients with STEMI undergoing primary PCI. However, it shed light on the potential benefits of empagliflozin in improving LVEF following STEMI.
REGISTRATION
Iranian Registry of Clinical Trials Platform ( https://irct.behdasht.gov.ir/ ) identifier number IRCT20111206008307N42.
简介
恩格列净是一种钠-葡萄糖协同转运蛋白 2（SGLT2）抑制剂，可改善心力衰竭患者的心血管结局，但在急性心肌梗死（AMI）患者中的疗效数据仍不清楚。本研究旨在评估在直接经皮冠状动脉介入治疗（PCI）前使用恩格列净治疗是否会改善与患者结局相关的参数。
方法
我们随机分配了 101 名非糖尿病和非心力衰竭的 ST 段抬高型心肌梗死（STEMI）患者，这些患者接受直接 PCI，并在 PCI 前给予恩格列净（10mg 一次，随后每天一次，持续 40 天）或安慰剂，同时接受标准治疗。主要结局为 PCI 后 40 天左心室射血分数（LVEF）的变化、心脏肌钙蛋白 I（cTnI）的变化及其曲线下面积（AUC）和峰值水平的估计值以及 PCI 后 90 分钟时导联上 ST 段的＞50%缓解情况。
结果
两组之间 ST 段缓解＞50%的发生率（46.0%比 45.0%；p=0.92）和各时间点 cTnI 的平均水平没有显著差异。cTnI 的估计平均[标准差（SD）]AUC 分别为干预组 955.0（595.7）ng h/ml 和对照组 999.7（474.7）ng h/ml（p=0.85），峰值 cTnI 水平没有显著差异。直接 PCI 后 40 天，恩格列净治疗组的平均（SD）LVEF 明显高于安慰剂组[43.2%（5.8%）比 39.2%（6.7%）；p=0.002]。
结论
在这项研究中，在接受直接 PCI 的 STEMI 患者中，两组之间 cTnI 水平和 ST 段缓解率没有显著差异。然而，它揭示了恩格列净在改善 STEMI 后 LVEF 方面的潜在益处。
注册
伊朗临床试验注册平台（https://irct.behdasht.gov.ir/）注册号 IRCT20111206008307N42。
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