Efficacy And Safety Of Drug Coated Balloon In Atherosclerotic Renal Artery Stenosis Revascularization

BackgroundRenal artery stenosis(RAS)refers to the stenosis of the main artery or main branch of renal artery on one or both sides(diameter stenosis ? 50%),thus causing secondary hypertension,renal insufficiency and other diseases.Common causes of RAS include atherosclerosis,Takayasu arteritis and fibromuscular dysplasia.Atherosclerotic renal artery stenosis(ARAS)is the main cause of RAS.ARAS can lead to refractory hypertension,end-stage renal disease and so on.The treatment of ARAS includes drug therapy,interventional therapy and surgical treatment.With the development of interventional technology,percutaneous transluminal renal angioplasty(PTRA)and percutaneous transluminal renal angioplasty and stenting(PTRAS)are widely used gradually.Renal artery interventional therapy can effectively relieve RAS and recover renal perfusion,which has a good clinical effect on ischemic nephropathy and renal vascular hypertension.However,traditional balloon dilation and stent implantation still face the problem of restenosis.As an emerging interventional therapy,drug coated balloon(DCB)angioplasty recently has been applied in coronary and peripheral arteries.However,there are few reports on the application of DCB applied on ARAS.The safety and efficacy of DCB applied on ARAS need to be further confirmed.ObjectiveThe purpose of this study was to evaluate the safety and efficacy of DCB applied in ARAS revascularization therapy.Methods40 patients who came to the First Affiliated Hospital of Zhengzhou University treated by interventional therapy during March 2016 to September 2018 were divided into two groups.The DCB group included 20 patients who were treated by DCB and the stent group included 20 patients who were treated by PTRAS.These 40 patients were analyzed retrospectively.The quantitative coronary angiography(QCA)software was used to analyze two groups' renal artery lesions quantitatively.In order to analyze the effectiveness of drug coated balloon angioplasty from anatomical side,the rate of diameter and area stenosis was compared before and immediately after the intervention,and also at six months' follow-up.Meanwhile,the number of successful and failed interventions was counted.The patients' serum creatinine(SCr),estimated glomerular filtration rate(eGFR)and blood pressure were also observed before and after the intervention to evaluate the safety and efficacy of DCBs.Results1.Among the 40 patients,23 were male and 17 were female,aged from 41 to 70 years,with an average age of(52.33±19.51)years.There was no statistical difference in gender,age,hypertension,diabetes,family history,smoking history,HbAlc,blood lipid levels,SCr,eGFR,NT-proBNP,LVEF between the two groups.2.Among the 20 patients who treated with DCBs,1 was failed and was implanted a stent in the intervention.Success rate of the DCB group was 95.0%.And the stent group' success rate of intervention was 100.0%.3.There was no statistical difference in reference lumen diameter,minimum lumen diameter,diameter stenosis rate and area stenosis rate before intervention between the two groups(P>0.01).The lumen gain of the stent group was more then that of the DCB group immediately after intervention(P<0.01).The lumen lose ofthe DCB group was less then that of the stent group at 6 months' follow-up(P <0.01).4.Among the 40 patients,one had renal artery dissection in the intervention.In the remaining 39 patients,there were no complications such as renal artery perforation,renal artery embolism,acute dissection or occlusion of main renal artery,rupture of renal artery and contrast-induced nephropathy.There were no MACE in two groups at 6 months' follow-up.5.In 19 patients who underwent successful PTRA,pre-intervention blood pressure was(151.1±18.2/88.7±16.3)mmHg,mean arterial pressure was(109.5±14.9)mmHg.After 6 months their blood pressure was(134.3±11.7/78.9±8.9)mmHg,and mean arterial pressure was(97.39±7.3)mmHg.There was no statistical difference in the effective rate of hypertension between two groups(84.2% vs.75%,P>0.01).6.In 19 patients who underwent successful PTRA,serum creatinine(SCr)was(71.3 ± 17.0)?mol/L,estimated glomerular filtration rate(eGFR)was(96.2 ± 20.5)mL/(min·1.73m2)before the intervention.At 48 hours to 72 hours after the intervention,SCr was(71.1 ± 14.8)?mol/L and eGFR was(88.7 ± 15.1)mL/(min·1.73m2).At 6 months follow-up,SCr was(71.4±19.3)?mol/L and eGFR was(82.2 ± 21.7)mL/(min·1.73m2).There was no statistical difference in renal function in two groups after the intervention.ConclusionPercutaneous renal artery drug coated balloon angioplasty is safe and effective interventional for ARAS.