Efficacy Of Indobufen After PTA For Arteriovenous Endovascular Fistula

Research background and purpose:Background:Hemodialysis is currently the most used renal replacement therapy for patients with end-stage renal disease（ESRD）in clinical practice.For maintenance hemodialysis（MHD）patients,the international NKF-K/DOQI guidelines recommend arteriovenous fistula（AVF）as the preferred vascular access for hemodialysis treatment.With the continuous improvement of hemodialysis technology and the improvement of hemodialysis patient management,the survival rate of maintenance hemodialysis patients has been greatly improved,and the establishment and maintenance of vascular access-commonly known as the patient’s"lifeline"-has received more and more attention.Approximately 20%of hemodialysis patients are hospitalized due to access-related complications^[1],with stenosis being the most common cause of arteriovenous endovascular fistula loss.Currently,minimally invasive percutaneous transluminal angioplasty（PTA）has become the technique of choice for the treatment of arteriovenous endovascular fistulas.Percutaneous transluminal angioplasty has the advantages of saving its own blood vessels,simple operation,minimal trauma,safety,and normal dialysis immediately after the procedure without the need for temporary dialysis catheter transition,etc.Some studies^[2]have shown that the success rate of PTA for the treatment of arteriovenous endovascular stenosis can reach 82%-94%,and the patency rate of endovascular fistula can reach 75%after 6 months,and after 2 years,this rate can be reduced The short-and medium-term results after PTA are fair,but the long-term results are poor due to the high recurrence rate,so prevention of restenosis after PTA for arteriovenous endovascular fistulas may prolong the life of the arteriovenous endovascular fistula.A large number of literature references^[3,4,5,6,7]have shown that indobufen,which has dual anticoagulant and antiplatelet aggregation effects,has a preventive effect on postoperative restenosis of arteriovenous endovascular fistulae in uremic maintenance hemodialysis patients,but there are no studies on the use of indobufen to prevent restenosis of vascular access after arteriovenous endovascular fistula PTA.In this study,we analyzed the relationship between the rate of vascular restenosis and the decrease in blood flow during dialysis and the incidence of adverse events in three groups of patients with oral indobufen,aspirin and blank control after PTA for arteriovenous endovascular fistula stenosis at 12 months of follow-up to elucidate the safety and efficacy of indobufen in preventing restenosis after PTA for arteriovenous endovascular fistula.Objective:This study was conducted to investigate the effectiveness and safety of indobufen therapy for the prevention of thrombosis and restenosis after percutaneous transluminal angioplasty for arteriovenous fistula.This study will provide the basis for clinicians to improve the quality of life of hemodialysis patients,increase the adequacy and reduce the postoperative medical costs.Materials and Methods:The study was a prospective study of 120 patients who participated in the"Observation of the efficacy of indobufen after PTA with ultrasound guidance in arteriovenous endovascular fistula"between January 2021 and-January 2022,who met the criteria for PTA for stenosis or thrombosis of arteriovenous endovascular fistula in maintenance hemodialysis.The study was divided into three groups:group A was the control group（aspirin 100 mg/d for 12 weeks starting on the day of surgery）,40 patients in total;group B was the experimental group（indobufen 100 mg/d for 12 weeks starting on the day of surgery）,40 patients in total;group C was the blank control group（regular treatment after surgery）,40 patients in total.Patients were observed for the rate of ultrasound-indicated lumen loss or thrombosis requiring reintervention at 6 weeks,3months,6 months and 12 months after surgery,the incidence of serious adverse events（aneurysm formation,bleeding at important sites）and the decline in blood flow from the intervention to the observation endpoint,and plotted to compare vascular patency before the reoccurrence of stenosis in arteriovenous endovascular fistula after PTA in the aspirin group,indobufen group and blank control group The Kaplan-meier survival curves for survival time were plotted,and P<0.05 was regarded as significant standard.Results:1.Before surgery,the inner diameter of vascular stenosis and hemodialysis blood flow in the three groups were compared,P>0.05;after surgery,the inner diameter of vascular stenosis and hemodialysis blood flow in the three groups were significantly improved compared with those before surgery,but P>0.05.2.Comparison of the rate of patients in the three groups requiring re-intervention due to lumen loss or thrombosis after PTA.At 6 weeks postoperatively,no cases requiring reintervention were seen in the indobufen and aspirin groups,and the intervention rate in the blank control group was5%,and P>0.05 for the three groups.At 3 months postoperatively,the intervention rates of the three groups were compared at P<0.05,among which the intervention rate of the indobufen group was lower than that of the blank control group at P<0.05,and the intervention rates ofthe indobufen group compared with the aspirin group and the aspirin group compared with the blank control group at P>0.05.At 6 months postoperatively,the rates of re-intervention in the three groups were compared at P<0.05,with the rates in the indobufen group being lower than those in the blank control group and the rates in the aspirin group being lower than those in the blank control group at P<0.05,and the rates in the indobufen and aspirin groups were compared at P>0.05.At 12 months postoperatively,the intervention rates in the indobufen,aspirin and blank control groups were 2.5%（1/40）,7.5%（3/40）and 22.5%（9/40）,respectively,with a statistically significant difference between the indobufen group and the blank control group（P<0.05）.There has no obvious differences（P>0.05）.3.The Kaplan-Meier survival curves were used to plot the survival time of endovascular fistula before the reoccurrence of stenosis within 12 months after PTA in each of the three groups.The survival time of endovascular fistula within one year after surgery was greater in the indobufen group than in the aspirin group than in the blank control group,p<0.05.The survival time in the indobufen group was higher than that in the blank control group,the survival time in the aspirin group was higher than that in the blank control group,p>0.05,which was statistically significant,and the survival time in the indobufen group was higher than that in the aspirin group,p>0.05,which was not statistically significant.4.The comparison of blood flow at the endpoint of observation at 12 months after surgery was（222.75±17.095ml/min）>（206.25±14.621ml/min）>aspirin group（206.25±14.621ml/min）>blank control group（198.25±16.624ml/min）in the indobufen group,p<0.05.Among them,the blood flow at the endpoint was higher in the indobufen group than in the aspirin group,and the blood flow at the endpoint was higher in the indobufen group than in the aspirin group.The end-point blood flow in the indobufen group was higher than that in the aspirin group,and the end-point blood flow in the aspirin group was higher than that in the blank control group,P<0.05.5.From the intervention to the end of observation,the blood flow decreased in the indobufen group<aspirin group<blank control group,P<0.05.The blood flow in the indobufen group decreased less than that in the aspirin group,the blood flow in the indobufen group decreased less than that in the blank control group,and the blood flow in the aspirin group decreased less than that in the blank control group,P<0.05.6.The comparison of the incidence of adverse events in the three drug subgroups,the incidence rate was:blank control group（2.5%）<indobufen group（5%）<aspirin group（20%）,and has no obvious difference.In which,the incidence of adverse events in the indobufen group was lower than that in the aspirin group,P>0.05;the incidence of adverse events in the blank control group was lower than that in the aspirin group,P<0.05;the incidence of adverse events in the indobufen group was higher than that in the blank control group,P>0.05,which was not statistically significant.There were no life-threatening serious adverse events in any of the three groups.Conclusions1.the use of indobufen after arteriovenous fistula PTA is effective in improving postoperative revascularization rate and flow rate during hemodialysis.2.The early administration of antiplatelet aggregation drugs after arteriovenous fistula PTA is effective in protecting the postoperative patency of arteriovenous fistula PTA,improving the flow of hemodialysis,and preventing the re-intervention of arteriovenous fistula,and both aspirin and indobufen are safe and effective,but indobufen is slightly more effective than aspirin treatment,and has fewer adverse effects and better safety than aspirin.