药物洗脱支架2年内再狭窄危险因素分析和Nomogram构建

目的探讨冠心病合并2型糖尿病患者药物洗脱支架(DES)植入后2年内再狭窄(ISR)危险因素并构建Nomogram模型。方法回顾性分析2010年1月—2020年2月在中国医学科学院阜外医院深圳医院植入DES的冠心病合并2型糖尿病患者临床资料。PASS估计模型产生队列样本量,根据冠状动脉造影结果分为支架内再狭窄组(DES-ISR)及非狭窄组(non-DES-ISR),对两组之间差异有统计学意义的参数进行单因素和条件性多因素Logistic回归分析构建Nomogram并在验证队列中验证其检验效能。结果模型产生队列共1741例,233例(13.4%)在植入DES后2年内确诊ISR,条件性多因素Logistic回归分析显示,DES-ISR的预测因素为肾小球滤过率(eGFR)<60 mL/(min·1.73 m²)(OR=2.77,95%CI:1.41~5.47,P=0.003)、血脂异常(OR=1.90,95%CI:1.30~2.78,P=0.001)、空腹血糖(FPG)≥6.5 mmol/L(OR=5.50,95%CI:3.05~9.92,P<0.001)、冠状动脉多支病变(OR=7.26,95%CI:3.27~16.11,P<0.001)、冠状动脉弥漫病变(OR=1.80,95%CI:1.13~2.88,P=0.014)、首次PCI操作时间≥60 min(OR=2.62,95%CI:1.13~6.05,P=0.024)和首次PCI为急诊(OR=2.20,95%CI:1.48~3.28,P<0.001)。模型验证队列102例,DES-ISR发生风险随Nomogram评分增高而增加,Nomogram模型受试者工作特征(ROC)曲线下面积为0.791(95%CI:0.753~0.829,P=0.019)。结论冠状动脉病变特征以及PCI操作程序是DES-ISR的重要预测因素,Nomogram能够较好地识别DES-ISR高危人群,能够为高危人群的随访干预提供有效的决策信息。

Predictors and Nomogram prediction model of in-stent restenosis within 2 years after drug-eluting stents implantation

Aim To investigate the risk factors of in-stent restenosis(ISR)within 2 years after the implantation of drug-eluting stent(DES)in patients with coronary heart disease and type 2 diabetes,and construct a Nomogram prediction model.Methods Clinical data of patients with coronary heart disease and type 2 diabetes who received DES at the Fuwai Hospital Chinese Academy of Medical Sciences,Shenzhen from January 2010 to February 2020 were retrospectively analyzed.The PASS estimation model generates cohort sample size,which was divided into ISR group(DES-ISR)and non-ISR(non-DES-ISR)group based on the results of coronary angiography.The single factor and conditional multivariate Logistic regression analysis were performed on the parameters with statistical significance between the two groups,and the Nomogram prediction model was constructed and its reliability was verified in the validation cohort.Results A total of 1741 cases were included in model generated cohort,233 cases(13.4%)were diagnosed with ISR within 2 years after implantation of DES.Conditional multivariate Logistic regression analysis showed that the predictor of DES-ISR was estimated glomerular filtration rate(eGFR)<60 mL/(min·1.73 m²)(OR=2.77,95%CI:1.41~5.47,P=0.003),dyslipidemia(OR=1.90,95%CI:1.30~2.78,P=0.001),fasting blood glucose(FPG)≥6.5 mmol/L(OR=5.50,95%CI:3.05~9.92,P<0.001),multivessel coronary artery disease(OR=7.26,95%CI:3.27~16.11,P<0.001),diffuse coronary artery disease(OR=1.80,95%CI:1.13~2.88,P=0.014),primary PCI operation time≥60 min(OR=2.62,95%CI:1.13~6.05,P=0.024)and emergency PCI(OR=2.20,95%CI:1.48~3.28,P<0.001).The model validation cohort contained 102 cases,the risk of DES-ISR increased with the increase of the Nomogram scores.The area under the receiver operating characteristic(ROC)curve of the Nomogram model was 0.791(95%CI:0.753~0.829,P=0.019).Conclusions The anatomical characteristics of coronary artery and PCI procedures are important predictors of DES-ISR.Nomogram can effectively identify high-risk groups of DES-ISR and provide effective decision-making information for follow-up and intervention of high-risk groups.