达格列净对2型糖尿病药物洗脱支架植入后临床结局的影响

Effectiveness of dapagliflozin on the clinical outcomes of the patients with diabetes who received drug eluting stenting

目的:基于真实世界临床数据,探讨达格列净对2型糖尿病患者药物洗脱支架植入后临床结局的影响。方法:采用回顾性观察性研究方法入选郑州大学第一附属医院2018年1月—2020年5月入院的所有接受药物洗脱支架植入的2型糖尿病患者,根据是否使用达格列净分组,随访观察主要结局终点包括全因死亡、心血管病死亡、非致死性心肌梗死和脑卒中,次要结局包括支架内再狭窄和再入院。结果:共筛选出1600例接受药物洗脱支架植入的2型糖尿病患者,1574例纳入研究,其中522例使用达格列净,1052例未使用达格列净。平均随访(18.7±6.0)个月,达格列净组的糖化血红蛋白浓度、男性比例和高血压人群比例高于对照组(P<0.05),在主要结局分析中,达格列净能降低全因性死亡(达格列净组1.7%,对照组5.1%;HR=0.455,95%CI0.224~0.922,P=0.029)和心血管病死亡(达格列净组1.5%,对照组4.8%,HR=0.439,95%CI0.208~0.927,P=0.005),但不能降低非致死性心肌梗死(HR=0.727,95%CI0.347~1.522,P=0.398)和脑卒中发生率(HR=1.312,95%CI0.675~2.547,P=0.423)。在次要结局分析中,达格列净能降低支架再狭窄(HR=0.783,95%CI0.635~0.964,P=0.021),但不能降低再入院发生率(HR=1.243;95%CI0.886~1.774,P=0.208)。结论:基于真实世界临床数据,达格列净能降低药物支架植入后2型糖尿病患者全因死亡、心血管病性死亡和支架再狭窄发生率,但未降低非致死性心肌梗死、脑卒中和再入院发生率,显著改善冠心病临床结局。

Objective: To explore the effectiveness of dapagliflozin on the clinical outcomes of the patients with diabetes who received drug eluting stenting based on the real world clinical data. Methods: After retrospective screening of all the patients with diabetes who received drug eluting stenting in Zhengzhou University First Affiliated Hospital from January 2018 to May 2020, the patients with type 2 diabetes mellitus(T2 DM) were divided into two group according to dapagliflozin. The primary clinical outcomes including all cause death, cardiovascular death, non-fatal myocardial infarction(MI) and stroke and the second clinical outcomes including in-stent restenosis and readmission were observed during following-up. Results: A total of 1600 patients with diabetes who received drug eluting stenting were screened and 1574 who were followed for a median of 18.7±6 months were included in this study. The 522 patients were in the dapagliflozin group, and 1052 patients were in the control group. The HbA1 c concentration and the proportion of hypertension and male in the dapagliflozin group were higher than those of the control group(P<0.05). In the primary outcome analysis, dapagliflozin could reduce all-cause mortality(ACM)(1.7% in the dapagliflozin group, 5.1% in the control group;HR=0.455, 95%CI 0.224 to 0.922, P=0.029) and cardiovascular mortality(CM)(1.5% in the dapagliflozin group, 4.8% in the control group, HR=0.439, 95%CI 0.208 to 0.927, P=0.005) but not reduce the incidence of non-fatal MI(HR=0.727, 95%CI 0.347 to 1.522, P=0.398) and stroke(HR=1.312, 95%CI 0.675 to 2.547, P=0.423). In the second outcome analysis, dapagliflozin could reduce the incidence of in-stent restenosis(HR=0.783, 95%CI 0.635 to 0.964, P=0.021) but not reduce the incidence of readmission(HR=1.243, 95%CI 0.886 to 1.774, P=0.208). Conclusion: For patients with diabetes who received drug eluting stenting, dapagliflozin could reduce ACM, CM and in-stent restenosis but not reduce the incidence of non-fatal MI, stroke and readmission.