| Objectives:(1)study 1: to observe the safety and efficacy of Drug eluted balloon(DEB)in the treatment of coronary artery bifurcation lesions.(2)study 2: To observe the efficacy of paclitaxel drug eluted balloon(DEB)dilation in patients with coronary artery bifurcation lesions and diabetes mellitus.To determine whether diabetes mellitus may affect the efficacy of DEB in the treatment of bifurcat ed coronary artery lesions.Methods:(1)This study included 115 cases of patients diagnosed with coronary artery bifurcation lesions in the department of cardiovascular medicine in the second affiliated hospital of the Army Military Medical University(The Third Military Medical University)from May 2016 to December 2016.Among them,49 cases of branched vessels underwent DEB dilatation,and 66 cases of branched vessels underwent normal balloon dilatation.We have checked the postoperative TIMI blood flow and all patients were followed up for major adverse cardiovascular events(including angina,acute myocardial infarction,target organ revascularization and cardiogenic death)at hospitalization,6th,9th and 12 th months after surgery.(2)This study included 105 cases of patients diagnosed with coronary artery b ifurcation lesion by the department of cardiovascular medicine in the second affiliate d hospital of the Army Military Medical University(The Third Military Medical Un iversity)from May 2016 to July 2017.Patients were divided into two groups accordi ng to whether they were combined with diabetes.Patients were followed up for majo r adverse cardiovascular events(including angina,acute myocardial infarction,target organ revascularization and cardiogenic death)at 6th,9th and 12 th months by teleph one,outpatient or inpatient after surgery.At 12 th months after surgery,Selective coron ary angiography was reviewed to determine whether the branch vessels appear restenosis.Results:(1)Study 1: All the 115 patients were successfully operated,and the postoperati ve TIMI blood flow of the branches was at 3rd grade.One patient in the normal bal loon group developed angina pectoris during postoperative hospitalization(mean 5.1 days).No MACE events occurred in patients in the drug-eluting balloon group during postoperative hospitalization(mean 4.7 days)(P>0.05).By the 12 th month after di scharge,MACEs occurred in 16 patients in the normal balloon group and 6 patients in the drug-eluting balloon group.According to Kaplan-meier analysis,the difference of MACEs incidence between the two groups was statistically significant(log-rank=0.04).(2)By the 6th month after operation,there was 1 MACE occurred in each grou p.By the 9th month after surgery,a total of 7 cases of MACEs occurred in the two groups,including 2 cases in the non-diabetic group and 5 cases in the diabetic grou p.By the 12 th month after surgery,MACEs occurred in 5 patients in the non-diabeti c group,with an incidence of 8.3%.MACEs occurred in 9 patients with diabetes me llitus,with an incidence of 20%.Multivariate COX regression model analysis showed that there was no statistically significant difference between the two groups(P=0.235).There was 57 patients(22 patients with diabetes mellitus)underwent selective cor onary angiography at the 12 th months after surgery.There were 2 patients in th e dia betes mellitus group developed branch vessel restenosis.The differences between suc h two groups was no statistically significant(P > 0.05).Conclusions:(1)Study 1: both types of balloons are safe in the treatment of bifurcated coronary artery lesions,but drug-eluting balloons are more effective than normal balloons in the treatment of bifurcated coronary artery lesions.(2)Combined with diabetes does not increase the incidence of MACE and restenosis after DEB dilatation in patients with coronary artery bifurcation lesion and DEB dilatation in these patients is safe and effective. |
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