Behzad Hossein, Mashayekhi Sina, Asham Hila, Sarbakhsh Parvin, Entezari-Maleki Taher
Department of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.
Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
J Cardiovasc Thorac Res. 2024;16(2):113-119. doi: 10.34172/jcvtr.33103. Epub 2024 Jun 25.
Percutaneous Coronary Intervention (PCI) is a fundamental procedure for coronary artery disease management, yet the risk of adverse events such periprocedural myocardial injury (PMI) persists. This double-blind, randomized clinical trial aims to assess the efficacy of empagliflozin in preventing myocardial injury during PCI procedure.
A total of 90 patients were randomly assigned to two groups A and B; Group A as the intervention group received empagliflozin 25 mg 24 hours before and empagliflozin 10 mg 1-2 hours before coronary intervention and group Bas the control group received placebo at similar intervals. The primary outcome involved comparing baseline, 8-hour, and 24-hour cTnI and baseline and 24-hour hs-CRP levels after PCI in both groups to measure the incidence of periprocedural myocardial injury (PMI) and anti-inflammatory effects of empagliflozin.
Baseline cTnI levels with =0.955, 8 hours after PCI with =0.469, and 24 hours after the intervention with =0.980 were not statistically different in the two groups. Baseline levels of hs-CRP in both intervention and control groups were not statistically significantly different (=0.982). Also, there was no statistically significant difference in hs-CRP levels 24 hours after PCI in two groups (=0.198). Finally, the results showed that MACEs did not occur in any of the groups.
The results of this trial could not express the advantages of acute pretreatment with empagliflozin in preventing PCI-related myocardial injury.
经皮冠状动脉介入治疗（PCI）是冠心病治疗的基本手段，但围手术期心肌损伤（PMI）等不良事件风险依然存在。这项双盲随机临床试验旨在评估恩格列净在预防PCI手术期间心肌损伤方面的疗效。
总共90例患者被随机分为A组和B组；A组作为干预组，在冠状动脉介入治疗前24小时服用25毫克恩格列净，在介入治疗前1 - 2小时服用10毫克恩格列净，B组作为对照组，在相同时间间隔服用安慰剂。主要结局是比较两组PCI术后基线、8小时和24小时的肌钙蛋白I（cTnI）水平以及基线和24小时的高敏C反应蛋白（hs-CRP）水平，以衡量围手术期心肌损伤（PMI）的发生率和恩格列净的抗炎作用。
两组患者基线cTnI水平（=0.955）、PCI术后8小时（=0.469）和干预后24小时（=0.980）差异无统计学意义。干预组和对照组hs-CRP基线水平差异无统计学意义（=0.982）。两组PCI术后24小时hs-CRP水平差异也无统计学意义（=0.198）。最后，结果显示两组均未发生主要不良心血管事件（MACE）。
该试验结果未能表明恩格列净急性预处理在预防PCI相关心肌损伤方面的优势。
