Analysis Of Efficacy Of Drug-coated Balloon In The Treatment Of Small Coronary Artery Disease In Type 2 Diabetic Patients

Objective:To compare the safety and efficiency of drug-coated balloon versus the second generation drug-eluting stent in the treatment of de novo small coronary artery disease in type 2 diabetic patients.Methods:A total of 94 patients with type 2 diabetic mellitus complicated by de novo small coronary artery disease who received treatment in the Department of Cardiology,The First Hospital of Shanxi Medical University between October 2019 and December 2020 were included in this study.These patients were divided into a drug-coated balloon group(n=53)and a drug-eluting stent group(n=41).Percutaneous coronary interventions was performed by an experienced team of physicians following the guidelines strictly.The general baseline data,past history,diabetes medication,target vessel,and results of angiography of preoperative and postoperative were retrospectively collected.The angiographic endpoints were the minimum lumen diameter,residual stenosis and late lumen loss of target vessels at 12 months.The clinical endpoint was major adverse cardiovascular events(MACE;death,myocardial infarction,target vessel revascularization)at 1,6,and 12 months after percutaneous coronary intervention by means of inpatient medical records,outpatient medical records and telephone follow-up.Results:1.In this study,there were no significant differences in general baseline data,history of present disease,target vessels and treatment of diabetes among 2 groups(P>0.05).Also,was there no difference in preoperative angiographic data between the two groups(P>0.05).2.Immediately after percutaneous coronary interventions,the angiographic results of the drug-coated balloon group and the drug-eluting stent group showed that the minimum lumen diameter was 1.93±0.21 vs.2.14±0.25 mm,P =0.005;the degree of lumen stenosis23.65±3.36% in DCB vs.15.86±3.49% in DES,P <0.001;the immediate lumen increase1.46±0.26 in DCB vs.1.64±0.22 mm in DES,P =0.016;3.At 12 months after percutaneous coronary interventions,the angiographic results of the drug balloon group and the drug-eluting stent group shown that the minimum lumen diameter was 1.83±0.18 vs.1.28±0.15 mm,P =0.025;the degree of lumen stenosis28.17±5.01% in DCB vs.35.24±5.24%,P =0.030;the late lumen loss 0.25±0.04 in DCB vs.0.66±0.15 mm in DES,P =0.037;4.Postoperative follow-up results showed that there was no significant difference in the occurrence of MACE events between the two groups of patients with drug-eluting balloon and drug-eluting stent at 1 month(P =0.253).The 6-month MACE rate for drug-coated balloons and drug-eluting stents was 3.8% vs.14.6%,P = 0.061;The 6-month myocardial infarction rate for drug-coated balloons and drug-eluting stents was 0% vs.4.9%,P = 0.104;The 6-month target vessel revascularization rate for drug-coated balloons and drug-eluting stents was 3.8% vs.9.7%,P = 0.104;After 12 months,the incidence of target vessel revascularization 5.6% in DCB vs.19.5% in DES,P = 0.038,and the incidence of MACE 7.5% in DCB vs.26.8% in DES,P = 0.011.5.Logistic regression analysis results showed,the 12-month risk of MACE in patients with hyperlipidemia was 1.587 times(95%CI: 1.085-2.571)compared with those without hyperlipidemia;the 12-month risk of MACE in patients with hypertension was 3.064 times(95%CI: 1.574-9.257)compared with those without hypertension.Conclusions:1.Compared with drug-eluting stent,drug-coated balloon for treatment of type 2diabetes mellitus complicated by de novo small coronary vessels disease may reduce the degree of late lumen loss,and may decrease the risk of major adverse cardiovascular events.2.Patients with hypertension,hyperlipidemia had a higher risk of MACE at 12 months after percutaneous coronary interventions.