Empagliflozin Effects in Patients with ST-Elevation Myocardial Infarction Undergoing Primary PCI: The EMI-STEMI Randomized Clinical Trial

IF 2.8 4区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS American Journal of Cardiovascular Drugs Pub Date : 2024-07-05 DOI:10.1007/s40256-024-00662-4

Elnaz Khani, Naser Aslanabadi, Kazem Mehravani, Haleh Rezaei, Hoda Afsharirad, Taher Entezari-Maleki

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Abstract

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.

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EMI-STEMI随机临床试验：Empagliflozin对接受初级PCI治疗的ST段抬高型心肌梗死患者的影响。

导言：恩格列净是一种钠-葡萄糖共转运体2（SGLT2）抑制剂，可改善心衰患者的心血管预后，但有关恩格列净在急性心肌梗死（AMI）中的疗效数据仍不清楚。本研究旨在评估在经皮冠状动脉介入治疗（PCI）前使用empagliflozin是否能改善与患者预后相关的参数：我们随机分配了101名接受初级PCI治疗的ST段抬高型心肌梗死（STEMI）非糖尿病和非心衰患者，除标准治疗外，还让他们接受empagliflozin（PCI前10毫克，每日一次，持续40天）或安慰剂治疗。主要结果是PCI 40天后左心室射血分数（LVEF）的变化、心肌肌钙蛋白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 90分钟后大于50%导联ST段的缓解：两组患者在每个时间点的 ST 段缓解率大于 50%（46.0% 对 45.0%；P = 0.92）和 cTnI 平均水平方面均无明显差异。干预组 cTnI 的估计平均值[标准差 (SD)] AUC 为 955.0 (595.7) ng h/ml，对照组为 999.7 (474.7) ng h/ml（p = 0.85），两组 cTnI 的峰值水平无显著差异。原发性PCI术后40天，empagliflozin治疗组患者的平均（标度）LVEF明显高于安慰剂组[43.2%（5.8%）对39.2%（6.7%）；P = 0.002]：在这项研究中，接受初级 PCI 治疗的 STEMI 患者的 cTnI 水平和 ST 段缓解率在各组间未发现明显差异。然而，该研究揭示了empagliflozin在改善STEMI术后LVEF方面的潜在益处：Iranian Registry of Clinical Trials Platform ( https://irct.behdasht.gov.ir/ ) identifier number IRCT20111206008307N42.

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来源期刊

American Journal of Cardiovascular Drugs 医学-心血管系统

CiteScore

6.70

自引率

3.30%

发文量

审稿时长

>12 weeks

期刊介绍： Promoting rational therapy within the discipline of cardiology, the American Journal of Cardiovascular Drugs covers all aspects of the treatment of cardiovascular disorders, particularly the place in therapy of newer and established agents. Via a program of reviews and original clinical research articles, the journal addresses major issues relating to treatment of these disorders, including the pharmacology, efficacy and adverse effects of the major classes of drugs; information on newly developed drugs and drug classes; the therapeutic implications of latest research into the aetiology of cardiovascular disorders; and the practical management of specific clinical situations. The American Journal of Cardiovascular Drugs offers a range of additional enhanced features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by a Key Points summary, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist patients, caregivers and others in understanding important medical advances. The journal also provides the option to include various other types of enhanced features including slide sets, videos and animations. All enhanced features are peer reviewed to the same high standard as the article itself. Peer review is conducted using Editorial Manager®, supported by a database of international experts. This database is shared with other Adis journals.