Clinical Research Of Drug-Coated Balloon In The Treatment Of De Novo Primary Lesion Of Large Coronary Artery

BackgroundAs the population ages,the incidence of cardiovascular disease Increases.Coronary artery disease(CAD)is currently the leading cause of death worldwide,which has led to the rapid development of Coronary artery interventional therapy.The emergence of Plain old balloon angioplasty(POBA)made restenosis its biggest limitation,and its occurrence was related to elastic recoil,negative vascular remodeling,and intimal hyperplasia.Compared with Plain old balloon angioplasty,Bare metal stents(BMS)fundamentally changed the prognosis of patients with Percutaneous Coronary Intervention(PCI).In addition,the introduction of Drug-eluting stents(DES)is the main method of percutaneous coronary intervention,which allows local cell inhibitor drug delivery,reduce the risk of restenosis and vascular revascularization,the therapeutic effect and prognosis of coronary heart disease(CHD)patients got improved significantly.Despite the success,numerous challenges remain,including the risks of stent restenosis and thrombosis,as well as the increased blood risk associated with long-term dual antiplatelet therapy.Currently,treatment with drug-coated balloon(DCB)is based on a new concept:implant-free intervention.An antiproliferative drug that covers the surface of the balloon directly after improving coronary blood flow without implantable foreign matter in the blood vessel is provided,so it is not limited by stent thrombosis and long-term dual antiplatelet therapy.DCB is similar in structure to a standard angioplasty catheter,but is coated with antiproliferative drugs and carrier materials or excipients.DCB is designed to provide an anti-proliferation drug,not to relieve stenosis.Therefore,lesions should be pretreated with standard balloon angioplasty prior to the use of DCB for optimal angiographic results.After the lesion has been adequately prepared,the lesion is treated by extending balloon inflation(30-60 seconds)to allow adequate drug transfer.Compared with DES,DCB has the advantages of uniform delivery of drugs to the vascular wall,immediate release of drugs without the use of polymers,shorter time of anti-platelet therapy,and absence of residual foreign substances in the blood vessels.Current studies have shown that drug-coated balloon mainly shows good effects in the treatment of in-stent restenosis and small-vessel lesions,while the therapeutic effect on de novo primary lesions of large coronary vessels has not been clearly concluded.ObjectiveTo investigate the clinical effect of drug-coated balloon(DCB)in the treatment of de novo primary lesions of large coronary vessels(vessel diameter≥2.8mm).MethodsA retrospective analysis was performed on 159 patients with de novo primary lesions of large coronary vessels who underwent interventional treatment for coronary heart disease in the department of cardiology,the first affiliated hospital of zhengzhou university from August 2018 to March 2019.Among them,56 patients(DCB group)were treated with drug-coated balloon(DCB).and 103 patients treated by drug-eluting stent(DES).Basic clinical data of patients in the two groups were observed.Patients were followed up by telephone or outpatient service and quantitative analysis of coronary angiography after 6 months.The minimum lumen diameter of MLD and the corresponding lumen stenosis degree were observed before and after surgery and at the 6-month follow-up,comparing target lesion late lumen loss(LLL),the incidence of major adverse cardiac events(MACE)and target vascular restenosis rate.MACE included myocardial infarction,target lesions revascularization(TLR),and all-cause death.All the data obtained were statistically analyzed using the statistical software SPSS 22.0.Results1.46 males in the DCB group were aged(57.50±10.56),and 82 males in the DES group were aged(58.02±9.98);There were no statistically significant differences in age,blood pressure,blood lipid,diabetes,smoking and history of PCI between the two groups(P>0.05).2.Compared with the DES group,the postoperative MLD in DCB group was smaller(2.26±0.37mm vs 3.27±0.52 mm P<0.05),and the degree of lumen stenosis was larger than that in DES group(P<0.05).There was no significant difference in MLD and lumen stenosis between the two groups during follow-up(2.11±0.52mm vs 2.30±0.63mm P>0.05).3.The LLL of DCB group was less than that of DES group(0.15±0.09mm vs 0.98 ± 0.15mm P<0.05).4.Patients in the two groups were followed up for 6 months after the operation.2 patients in the DCB group had target lesion revascularization therapy,with the MACE rate of 3.9%(2/51).3 patients in the DES group had target lesion revascularization therapy,with the MACE rate was 3.1%(3/98).No myocardial infarction or all-cause death occurred in either group.There was no statistically significant difference in the incidence of major adverse cardiovascular events between the two groups(3.9%vs 3.1%P>0.05).5.There was no target vessel restenosis in DCB group,and the restenosis rate was 0%(0/51).There were 3 cases of stent restenosis in DES group,and the restenosis rate was 3.1%(3/98).There was no significant difference in the incidence of restenosis between the two groups(0 vs 3.1%P>0.05).ConclusionDCB is safe and effective in the treatment of de novo primary lesions of large coronary vessels and can effectively reduce target lesions LLL.