Comparison Of Clinical Effects Of Drug-Coated Balloon And Drug-Eluting Stent On Marginal In-Stent Restenosis

Objective:To compare the clinical efficacy of drug-coated balloon and drug-eluting stent in patients with marginal in-stent restenosis after coronary stent implantation immediately and three months after operation.Methods:A retrospective study was selected from September 2017 to September2019 in Liaoning Provincial People's Hospital.The result of coronary angiography showed 74 patients with marginal in-stent restenosis(In-stent Restenosis,ISR).According to the patient's condition and the characteristics of the disease,interventional treatment is determined by the surgeon and approved by the patient and family members,the patients treated with drug-coated balloon(Drug-Coated Balloon,DCB)were included in the DCB group(30 cases)as the trial group,and patients treated with drugeluting stent(Drug-Eluting Stent,DES)were included in the DES group(44 cases)as the control group.The relevant clinical data such as age,gender,past history,laboratory indexes and the medication of cardiovascular related diseases before operation,preoperative lesion characteristics,spreading pressure and expansion time during the surgery of the two groups of patients were collected.The success rate,lumen acquisition,coronary residual stenosis,recurrent angina and changes of electrocardiogram were compared.The patients were followed up for three months.After the three months,the MACE events,target revascularization rate,recurrent angina pectoris,electrocardiogram changes and left ventricular ejection fraction of the two groups were compared and statistically analyzed.The main clinical end points of this trial were the difference of immediate postoperative lumen acquisition,the coronary residual stenosis,the success rate of operation,the improvement of symptoms between DES and DCB,and the MACE events,the changes of electrocardiogram and cardiac ultrasound,the condition of recurrent discomfort occurring 3 months after the operation between DES and DCB.The secondary study endpoint was target lesion revascularization occurring 3 months after the operation between two groups.the results were statistically analyzed using SPSS 23.0.Results:1.There was no significant difference in the general data,related laboratory indexes,related auxiliary examination results and preoperative medication status between DCB and DES groups(P>0.05).There was no significant difference in the preoperative coronary target lesion location,Mehran classification of marginal in-stent restenosis and spreading pressure during surgery between DCB and DES groups(P>0.05).The duration of intraoperative expansion of DBC is longer than the duration of intraoperative expansion of DES[(46.83±10.79)s vs.(2.23±0.64)s,P = 0].2.The success rate of immediate operation was 100% in both DCB and DES groups.postoperative luminal gain [(2.3±0.64)mm vs(2.53±0.56)mm P=0.275] and the degree of residual stenosis of blood vessels[(3±7.02)% vs(0.91±4.73)% P=0.085]have no statistical difference in both groups;After operation,there was no statistical difference in the number of symptoms of angina pectoris again [2% vs 14.91%P=0.405];there was no electrocardiogram change indicating myocardial ischemia or acute myocardial infarction after operation.3.There was no incident of cardiogenic death,acute myocardial infarction and stroke occurred in DCB and DES groups during the three-month follow-up.In the DCB group,the number of symptom-driven patients undergoing coronary arteriongraphy again who were re-implanted with stents is 0,the number of re-implanted stents account for 0% of the total number.In the DES group,the number of symptom-driven patients undergoing coronary arteriongraphy again who were re-implanted with stents is 3,the number of reimplanted stents account for 6.82% of the total number.there was no statistical difference in MACE events at 3 months follow-up [(0/30 vs(3/44),P=0.267];The number of ECG changes in DCB and DES groups was 0 following up three months after operation;There was no statistical difference in the number of angina symptoms between the two groups following up three months after operation [(9/30)vs(9/44),P=0.347];There was no difference in cardiac ultrasound ejection fraction between the two groups following up three months after operation [(0/30)vs(3/44),P=0.267];There was no statistical difference in the rate of target lesion reconstruction between the two groups following up three months after operation(Target Lesion Revascularization,TLR)[(0/30)vs(3/44),P=0.267].Conclusion: There was no significant difference in the immediate clinical effect and the 3 months clinical effect of marginal in-stent restenosis after coronary stent implantation between DCB and DES.DCB has the advantages of avoiding repeated stent placement,shortening the time of double antiplatelet therapy and reducing the risk of bleeding.Due to the limited data of this trial,more randomized controlled trials are needed to confirm that DCB have more application prospects in the treatment of marginal in-stent restenosis.