基于倾向性评分匹配法研究SGLT2i对射血分数中间值心衰患者心血管结局的影响

To Investigate the Effect of SGLT2i on Cardiovascular Outcomes in Patients with Heart Failure with Mid-range Ejection Fraction Based on Propensity Score Matching

目的:观察钠-葡萄糖共转运蛋白2抑制剂(Sodium-glucose cotransporter 2 inhibitors,SGLT2i)在真实世界中对伴或不伴2型糖尿病的慢性射血分数中间值心衰(heart failure with mid-range ejection fraction,HFmrEF)患者心血管结局的影响。方法:本研究为单中心回顾性队列研究,选取2019年1月至2021年12月承德市中心医院的伴或不伴2型糖尿病的728名HFmrEF患者作为研究对象,根据治疗方案不同分为暴露组和对照组。对照组患者应用指南导向的常规心力衰竭药物治疗,暴露组在常规心衰药物治疗的基础上联合SGLT2i达格列净片10 mg,1次/d,两组维持治疗方案治疗至少6个月。以SGLT2i为分组变量,以年龄、性别、吸烟史、饮酒史、高血压病史、糖尿病病史、高脂血症病史、冠心病病史、卒中史、经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)史、冠状动脉旁路移植术(coronary artery bypass grafting,CABG)史、永久起搏器植入史、左室射血分数(left ventricular ejection fraction,LVEF)、肾小球滤过率(estimated glomerular filtration rate,eGFR)及B型利钠肽(B-type natriuretic peptide,BNP)水平等观察指标作为倾向性评分匹配要素,对两组进行倾向评分匹配。使用Kaplan-Meier方法生成生存曲线,应用多变量Cox比例风险回归对终点事件进行分析。主要终点事件是因心衰住院、因心衰紧急就诊、心血管原因死亡的复合终点。结果:经倾向性评分匹配生成108对匹配对,两组患者基线特征均衡,不再有统计学差异。在中位随访时间19个月内,与对照组相比,暴露组主要复合终点的发生风险显著降低(HR=0.51,95%CI:0.30~0.86,P=0.01)。这种影响主要与暴露组较低的因心衰住院和因心衰紧急就诊风险有关。与对照组相比,暴露组因心衰住院的风险显著降低(HR=0.53,95%CI:0.30~0.94,P=0.027);暴露组因心衰紧急就诊的风险显著降低(HR=0.43,95%CI:0.20~0.97,P=0.035)。两组的心血管原因死亡和全因死亡风险无统计学差异。结论:SGLT2i达格列净显著降低了伴或不伴2型糖尿病慢性HFmrEF患者因心衰住院、因心衰紧急就诊的风险。

Objective:To observe the real-world effects of sodium-glucose cotransporter 2 inhibitors(SGLT2i)on cardiovascular outcomes in patients with chronic heart failure with mid-range ejection fraction(HFmrEF)with or without type 2 diabetes mellitus.Methods:This study is a single-center retrospective cohort study.A total of 728 HFmrEF patients with or without type 2 diabetes mellitus in Chengde Central Hospital from January 2019 to December 2021 were selected as research subjects and divided into exposure group and control group according to different treatment regimen.Patients in the control group were treated with guideline-oriented conventional heart failure medication,while patients in the exposure group were treated with dapagliflozin(at a dose of 10 mg once daily)in addition to conventional heart failure medication treatment.Both groups were treated with maintenance therapy for at least 6 months.SGLT2i was used as the grouping variable.Age,sex,smoking history,drinking history,hypertension history,diabetes history,hyperlipidemia history,coronary heart disease history,stroke history,percutaneous coronary intervention,History of PCI,history of coronary artery bypass grafting(CABG),history of permanent pacemaker implantation,and left ventricular ejection fraction(LVEF),estimated glomerular filtration rate(eGFR)and B-type natriuretic peptide(BNP)level were used as matching factors for propensity score.Propensity score matching was performed between the two groups.The Kaplan-Meier method was used to generate survival curves,and multivariate Cox proportional hazards regression was used to analyze end-point events.The primary endpoint event was a composite of hospitalization for heart failure,emergency admission for heart failure,and death from cardiovascular causes.Results:After propensity score matching,108 matching pairs were generated.The baseline characteristics of the two groups of patients were balanced,and there was no statistical difference.At a median follow-up of 19 months,the risk of the primary composite end point was significantly lower in the exposure group than in the control group(HR=0.51,95%CI:0.30~0.86,P=0.01).This effect was primarily associated with a lower risk of hospitalization for heart failure and emergency admission for heart failure in the exposed group.Compared with the control group,the risk of hospitalization for heart failure was significantly reduced in the exposure group(HR=0.53,95%CI:0.30~0.94,P=0.027).The risk of emergency admission for heart failure was significantly lower in the exposed group(HR=0.43,95%CI:0.20~0.97,P=0.035).The risk of death from cardiovascular causes and death from any cause did not differ between the two groups.Conclusion:SGLT2i dapagliflozin significantly reduced the risk of hospitalization for heart failure and emergency admission for heart failure in patients with chronic HFmrEF with or without type 2 diabetes mellitus.