| Objective:This study is a retrospective analysis to investigate the safety and efficacy of bioresorbable scaffolds for de novo coronary lesions compared with the second generation drug-eluting stent.Methods:Patients who underwent percutaneous coronary intervention(PCI)for de novo coronary lesions in the Department of Cardiology of the first Hospital of Shanxi Medical University from October 2019 to February 2021 were selected into the group according to the established inclusion criteria and exclusion criteria.Finally,75 patients were included in the domestic bioresorbable scaffolds group(BRS group,n=75)and 183patients in the second generation drug eluting stent group(DES group,n=183).The general baseline data,past history,target vessel distribution and so on were collected retrospectively.1.Clinical outcome:The patients in the two groups were followed up at 1,6 and 12 months after operation.the occurrence of major adverse cardiovascular events(MACE)in the two groups during the follow-up period was observed and compared between the two groups.The MACE defined in this study were cardiogenic death,myocardial infarction,revascularization of target vessels and all-cause death.2.Intracavitary imaging outcome:The results of optical coherence tomography(OCT)before operation,immediately after operation and 12 months after operation in the bioresorbable scaffolds stent group were compared in the group.3.Multivariate logistic regression analysis with 12-month MACE events as dependent variables.Results:1.According to the results of statistical analysis,there was no significant difference in baseline data and angiographic data between BRS group and DES group.2.One month after PCI,the incidence of MACE events in BRS group and DES group was(1.3%vs.2.7%p=0.824);Six months after PCI,the ratio between the two groups was(5.3%vs.4.9%p=1.000);Twelve months after PCI,the ratio between the two groups was(9.3%vs.9.8%,p=0.901);all the differences were not statistically significant.3.The OCT results of patients in BRS group before operation,immediately after operation and 12 months after operation were as follows:(1)Strut level analysis:the proportion of incomplete strut apposition;(%)was 0.2±0.3;the proportion of uncovered struts(%)was 0.19±0.35;(2)Cross-sectional level analysis:Late lumen loss(mm)0.22±0.31;uncovered struts>20%section was not found;thrombus area>300um~2section was not found.4.Multivariate Logistic regression analysis showed that T2DM,hypertension and smoking were independent risk factors for 12-month MACE.The risk of MACE events in patients with T2DM at 12 months was 5.739 times higher than that in the general population(95%CI:2.429～13.557);the risk of MACE events in patients with hypertension at 12 months was 3.550 times higher than that in the general population(95%CI:1.181～10.675);and the risk of MACE events in patients with smoking history at12 months was 3.729 times higher than that in the general population(95%CI:1.437～9.674).Conclusion:1.The safety and efficacy of domestic bioresorbable scaffolds in the treatment of de novo coronary lesions in coronary heart disease was not inferior to that of the second generation drug-eluting stents within 1 year after operation.2.Patients with a history of type 2 diabetes,smoking and hypertension had a higher risk of MACE 12 months after operation. |
