Clinical Efficacy Of Drug-coated Balloon In The Treatment Of Coronary In-stent Restenosis And Small Vessel Disease

Objective To observe the clinical effect of drug-coated balloon(DCB)on coronary in-stent restenosis(ISR)and small vessel disease,and evaluate whether drug-coated balloon is an optimal strategy for coronary revascularization in ISR and small vessel lesionsMethods A total of 48 patients with coronary heart disease receiving DCB interventional therapy in the Second Affiliated Hospital of Anhui Medical University from January,2018 to October,2019 were selected as the experimental group,including22 patients with ISR and 26 patients with small vessel lesions,and 48 patients receiving DES with similar general information and the same vascular lesion type were selected as the control group.In the DCB group,conventional or semi-compliant balloon predilation was used to determine the lesion site by coronary angiography,and no vascular dissection was confirmed or was limited to type A and type B dissections(NHLBI classification),TIMI blood flow grade III and residual stenosis <30%,DCB(Sequent Please,B.Braun Melsungen AG,Germany)was sent through the finger guide wire to cover the length of the pretreated site and exceeded the edge by 2-3 mm each.After positioning,the pretreated site was expanded for 30-60 s.If C-type and above dissections appeared during the operation,the DES was resuscitated.Postoperatively,all patients received dual antiplatelet drugs(aspirin + clopidogrel/ticagrelor),which were maintained for 1-3 months.Diseased vessels in the DES group were predilated with compliant balloon and then implanted with drug-coated stents of appropriate diameter and length,followed by dual antiplatelet therapy for at least 12 months.Cardiac death,non-fatal acute myocardial infarction(AMI),and target lesion revascularization(TLR)were taken as the main endpoint for observation of major adverse cardiac events(MACE),recorded coronary angiography or coronary CT reexamination.The statistical data were expressed as mean ± standard deviation(±s),independent sample t test was used for comparison between groups,and enumeration data were expressed as case number or percentage.Chi-square test or exact probability method was used for comparison between groups.Kaplan Meier curve was used for survival analysis.P<0.05 indicates that the difference is statistically significant.Results The average follow-up time was(9±5)months,2 groups of patients with no deaths occurred,MACE events in DES group(8.34%)were higher than the DCB incidence(4.17%),but no statistical difference was found between two groups(P >0.05).There was no cardiac death in the two groups,no non-fatal AMI in the DCB group and 1 case in the DES group(2.08%),and there was no statistical difference between the two groups(P > 0.05),DCB group had TLR in 2 cases(4.17%),lower than DES group in 4 cases(8.34%),no statistical difference was found between two groups(P > 0.05).In the DCB group at(9±4)months,19 patients underwent coronary angiography and 4 patients underwent coronary CT,including 10 patients of ISR(1patient developed 85% stenosis),and 13 patients of small vessel lesions(1 patient developed 90% vascular stenosis).In the DES group,14 patients underwent coronary angiography at(8±5)months,6 patients of ISR(1 developed 80% vascular stenosis)and 8 patients of small vessel lesions(1 developed 99% vascular stenosis as non-fatal AMI,2 developed 75% and 80% vascular stenosis).Survival curve analysis showed that there was no statistically significant difference in MACE free survival rate between the two groups during the follow-up(P=0.406).Conclusion The clinical efficacy of drug-coated balloon in the treatment of coronary stent restenosis and small vessel lesions is not inferior to that of drug-coated stent.It has the characteristics of shorter duration of dual antiplatelet therapy and no metal implants,so it can be used as an important strategy for coronary revascularization and is worthy of clinical promotion.