Autologous arteriovenous fistula (AVF) is the preferred vascular pathway type for maintenance hemodialysis (MHD) patients. The K/DOQI guidelines suggest that the use of percutaneous transluminal angioplasty (PTA) as the primary treatment for AVF stenosis is reasonable. However, the durability of PTA is limited. In order to reduce the risk of dysfunction recurrence after the intervention, there have been reports in recent years that drug-coated balloons (DCB) are used in the treatment of vascular stenosis in hemodialysis. Multiple factors have limited the efficacy of DCB. Previous studies on the related factors of hemodialysis access stenosis showed that Dyslipidemia was significantly related to the short initial patency rate, and Dyslipidemia was an important predictor of secondary patency loss. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are a new type of lipid-lowering drug that can prevent vascular calcification. Previous studies have shown that PCSK9 inhibitors have good lipid-lowering effects in both MHD patients and nondialysis patients, and the use of PSK9 inhibitors at the same dose as nondialysis patients is safe in MHD patients. There are currently few studies on the use of paclitaxel-releasing balloon dilation combined with PCSK9 inhibitors to improve autologous internal fistula. Therefore, the investigators applied a prospective, randomized, and controlled study method to preliminarily explore the effect of paclitaxel releasing balloon combined with PCSK9 inhibitor on improving the postoperative patency rate of AVF and the safety of the combined application.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
The treatment group received postoperative use of 140 mg of Ribavirin, administered every two weeks, with 140 mg administered subcutaneously for a total of 48 weeks. There was no additional intervention with lipid-lowering drugs in the control group.
Yuanyuan Xie
Shanghai, Pudong, China
RECRUITINGValue of vessel diameter
ultrasonic measurement
Time frame: 24 week, 48 week
Value of volume of blood flow
ultrasonic measurement
Time frame: 24 week, 48 week
Value of peak systolic velocity ratio(PSVR)
ultrasonic measurement
Time frame: 24 week, 48 week
Incidence of Re intervention of fistula
Event recording
Time frame: 48 week
Endometrium
Ultrasonic measurement of changes in thickness of vascular intima , expressed in millimeters
Time frame: 24 week, 48 week
RA
Arteriovenous fistula recirculation rate
Time frame: 24 week, 48 week
BTM
Blood temperature monitoring, testing of specific modules of the hemodialysis machine. Expressed as a percentage.
Time frame: 24 week, 48 week
Adequacy of dialysis
spKT/V
Time frame: 24 week, 48 week
Blood routine
Concentration of hemoglobin, white blood cell count, platelet
Time frame: 12 week, 24 week, 48 week
liver function
Concentration of GPT, GOT
Time frame: 12 week, 24 week, 48 week
Concentration of blood sugar
Time frame: 12 week, 24 week, 48 week
Concentration of CRP
Time frame: 12 week, 24 week, 48 week
blood lipids
Concentration of cholesterol, triglyceride, LDL-c, HDL
Time frame: 12 week, 24 week, 48 week
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