钠-葡萄糖共转运蛋白2抑制剂对急性心肌梗死合并2型糖尿病患者的安全性及有效性评价

Safety and efficacy of sodium-glucose co-transporter-2 inhibitor for patients with acute myocardial infarction and diabetes

目的:探究钠-葡萄糖共转运蛋白2抑制剂(sodium-glucose co-transporter-2 inhibitor,SGLT2i)对合并2型糖尿病(type 2 diabetes mellitus,T2DM)的急性心肌梗死(acute myocardial infarction,AMI)患者的疗效及安全性。方法:研究纳入2018年1月至2023年1月,在首都医科大学附属北京安贞医院行PCI手术且合并T2DM的AMI患者共2 170例,其中357例患者使用SGLT2i,并根据患者出院带药是否使用SGLT2i分成两组:SGLT2i组和常规降糖组,通过倾向性匹配法进行1:1匹配。本研究主要有效性终点事件为支架术后12个月内心血管不良事件(major adverse cardiovascular events,MACE),包含全因死亡、非致命心肌梗死、或缺血相关血运重建,主要安全终点事件为严重出血事件。结果:通过倾向评分匹配成功357对,两组患者基线特征基本一致,差异无统计学意义。研究平均随访(11.7±1.4)个月。与常规降糖组相比,达格列净组的主要有效性终点事件(HR=0.47,95%CI 0.27~0.81,P=0.006)以及次要终点事件中缺血相关血运重建(HR=0.53,95%CI:0.30~0.93,P=0.026)的发生率较低。两组的主要安全性终点事件(HR=0.72,95%CI:0.29~1.81,P=0.492)、全因死亡(HR=0.49,95%CI:0.23~1.06,P=0.069)和心肌梗死(HR=0.62,95%CI:0.32~1.18,P=0.142)发生率差异未见统计学意义。结论:SGLT2i可以降低合并2型糖尿病的急性心肌梗死患者的MACE、心肌梗死或缺血相关血运重建发生率,同时并不增加安全事件风险。

Objective:To explore the efficacy and safety of sodium-glucose co-transporter-2 inhibitor(SGLT2i)in patients with acute myocardial infarction(AMI)complicated with Type 2 diabetes mellitus(T2DM).Methods:The study collected 2170 AMI patients with T2DM who underwent PCI at Anzhen Hospital affiliated to Capital Medical University from January 2018 to January 2023,of which 357 patients were treated with SGLT2i.Patients were divided into two groups according to whether they used SGLT2i or not:SGLT2i group and routine drug group and matched 1:1 according to the propensity score matching.The primary efficacy outcome was major adverse cardiovascular events(MACE)within 12 months after PCI,including all-cause death,non-fatal myocardial infarction,or ischemia-driven revascularization.The primary safety outcome was major bleeding.Results:After propensity score matching,357 patients in the SGLT2i group and routine drug group were included in the final analysis,and the difference of baseline characteristics was not observed with no statistical significance.The average follow-up period was(11.7±1.4)months.Compared to the routine drug group,the incidence of the primary effective endpoint events in the SGLT2i group was lower(HR=0.47,95%CI:0.27-0.81,P=0.006).And the incidence of ischemia-driven revascularization(HR=0.53,95%CI:0.30-0.93,P=0.026)was also lower in the Dapagliflozin group.There was no significant difference in the incidence of major safety outcome(HR=0.72,95%CI:0.29-1.81,P=0.492),all-cause death(HR=0.49,95%CI:0.23-1.06,P=0.069)and myocardial infarction(HR=0.62,95%CI:0.32-1.18,P=0.142)between the two groups.Conclusions:SGLT2i reduces the incidence of MACE,myocardial infarction or ischemia-related revascularization in patients with AMI complicated with T2DM without increasing the risk of safety events.