Study On The Efficacy Of Drug Coated Balloon In The Treatment Of De Novo Large Coronary Vessel Disease With Diabetes

Background: The incidence and mortality of Coronary artery atherosclerotic Heart Disease(CAD)are on the rise.The treatment of Coronary heart disease mainly includes drug treatment,Percutaneous Intervention(PCI)and Coronary Artery Bypass Grafting(CABG)treatment.At present,PCI is the most commonly used invasive treatment for patients with coronary heart disease.The most common treatment is the use of Drug eluting stents(DESS),which expand in the lumen of the affected vessels and slowly release anti-endothelial drugs to improve the local blood supply.Intrastent restenosis is a major problem with balloon dilation and bare metal stents,and DES successfully solved this problem.The main problem of DES is the risk of stent thrombosis caused by delayed endothelium coverage or stent attachment problems caused by drug coating.Drug-coated balloon(DCB)is a new interventional treatment measure after the concept of implantless.DCB has many theoretical advantages over DES.DCB is composed of balloon and anti-proliferative drugs on the surface,and has the same operation mode as DES.Different from DES,there is no residue in the lumen after DCB,which avoids the occurrence of stent thrombosis caused by stent implantation but poor adherence or other reasons.However,if blood vessels are torn and dissected after DCB high pressure vasodilation,the implantation of salvage stent is needed.Diabetes mellitus is a group of syndromes characterized by metabolic disorders of glucose,fat,protein and other substances,is an independent risk factor for coronary heart disease,due to the sustained high blood sugar condition damage vascular endothelial cells,lead to reduced Numbers of vascular endothelial cells,increase the body’s inflammatory response,lesions tend to be more complex,They are more likely to form thrombosis and have a worse long-term prognosis.DCB is the grade I recommendation of the guideline for in-stent restenosis.The efficacy of DCB for bifurcation lesions,de novo small vessel lesions,and opening lesions has been verified.However,the efficacy of DCB in large vessel disease complicated with diabetes mellitus has not been reported.This study was intended to retrospectively analyze the efficacy of DCB in this type of disease,with DES as the control group.Objective: To investigate the efficacy of DCB in patients with de novo large coronary heart disease with diabetic disease.Methods: Patients with Coronary heart disease combined with diabetes admitted to Fuwai Central China Cardiovascular Hospital from January 2018 to May 2019 were retrospectively and continuously collected,and Coronary angiogram(CAG)was performed to show de novo Coronary artery lesions with a reference diameter≥3.0mm.DES implantation was used as the control group.According to interventional treatment methods,87 cases were divided into drug-eluting stent group(DES group)and 73 cases were drug coated balloon group(DCB group).Retrospective collection of general baseline data: sex,age.Clinical characteristics: history of present disease,past history,height and weight,laboratory results,echocardiography,etc.The operative results included operative time,CAG results,diameter and length of implanted DES or DCB,and residual luminal stenosis.The intraoperative and postoperative lesions of CAG and PCI were observed and recorded,whether there was vascular dissection after pretreatment,and the incidence of Major Adverse Cardiovascular Events(MACE)12 months after surgery.These include nonfatal myocardial infarction,fatal or nonfatal ischemic stroke,cardiogenic death,stent thrombosis,and target vessel revascularization(TVR).Results: A total of 160 patients were included in this retrospective study,including 87 patients in the drug-coated stent group(DES group),with an average age of(61.46±10.3)years old,60 males(69%)and 27 females(31%),and 73 patients in the drug-coated balloon group(DCB group),with an average age of(59.7±10.67)years old,52 males(71.2%).21 cases were female(21.8%).1.There were no significant differences in smoking history,drinking history,history of hyperlipidemia,history of hypertension,course of hypertension and diabetes mellitus,BSA,BMI and number of vascular lesions between 2 groups(P > 0.05).2.Test results: glycosylated hemoglobin,T3,T4,thyroid stimulating hormone,urea,creatinine,K,Na,Cl,Ca,TC,TG,LDL-C,HDL-C,Hb,there was no statistically significant difference is compared between two groups(P > 0.05),shows the results of preoperative patients with two groups of test data in the differences of no statistical significance.3.There were no statistically significant differences in LVEF value(P= 0.11> 0.05),LVEDD(P= 0.43> 0.05)and LVESD(P= 0.083> 0.05)before surgery between the two groups,indicating that the data of LVEF,LVEDD and LVESD before surgery between the two groups were parallel,and the difference was not statistically significant.4.In the DES group,LVEF and LVESD were improved 1 year after surgery compared with those before surgery(P < 0.05).There was no significant improvement of LVEDD in both groups at 1 year after surgery(P= 0.068> 0.05).In the DCB group,1 year after surgery and before surgery,the indexes of LVEF,LVEDD and LVESD showed improvement after surgery compared with before surgery,and the difference was statistically significant(P <0.05).5.At 1 year after surgery,the improvement of LVEF value in the DCB group was significantly higher than that in the DES group,with statistical significance(P < 0.05).There was no significant difference between LVEDD and LVESD(P < 0.05).According to the results,although the postoperative 1 year compared with the preoperative improvement,but from the value of the normal range.6.There was no statistically significant difference in the types of lesions between the two groups(P= 0.499> 0.05),no statistically significant difference in the length of lesions between the two groups,and no statistically significant difference in the diameter and length of DES/DCB between the two groups(P= 0.463> 0.05).7.In the 1-year follow-up,3.4% of patients in the DES group received target vessel revascularization,while 6.8% of patients in the DCB group received target vessel revascularization,and the difference between the two groups was not statistically significant(P=0.326 > 0.05).No non-fatal myocardial infarction,fatal or non-fatal ischemic stroke,cardiogenic death or stent thrombosis occurred in both groups.There was no incident of emergency PCI due to acute vascular occlusion.8.There was no significant difference in endpoint-free survival analysis between the two groups(log-rank=0.874,P= 0.349> 0.05).Conclusion:1.In patients with coronary heart disease complicated with diabetes,the use of DCB can achieve similar clinical effects as that of DES for primary coronary artery stenosis with diameter≥3mm;2.The cardiovascular prognosis 1 year after PCI was not worse than that of DES group.