Exploratory Research of PCSK9 Inhibitor on Patency of aAVF After PTA With PCB

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Hemodialysis Access Failure

Treatments

Biological: pcsk9 inhibitor

Study type

Interventional

Funder types

Other

Identifiers

NCT06034691

LY2023-113-A

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

17 to 76 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Agree to join this study and sign an informed consent form
Age ≥ 18 years old and ≤ 75 years old, regardless of gender
Maintenance hemodialysis patients using autologous arteriovenous fistula (AVF), with a dialysis frequency of three times a week
AVF venous stenosis: The local stenosis rate exceeds 50% of the normal diameter of nearby blood vessels and is accompanied by at least one of the following conditions:
1. The natural blood flow of the internal fistula is less than 500ml/min or has decreased by more than 25% compared to the previous examination result
2. Unable to meet the required blood flow for dialysis prescription (blood flow<200ml/min, and cannot be corrected after adjusting the puncture needle position)
3. Decreased arterial pressure or increased venous pressure during dialysis (monitoring arterial pressure<-120mmHg for more than 2 consecutive times or monitoring venous pressure>120mmHg while maintaining 200ml/min blood flow)
4. Difficulty in puncture: A qualified nurse who has difficulty puncturing for 3 consecutive days of hemodialysis (blood can only be drawn out after more than two punctures)
5. Decreased dialysis adequacy [arteriovenous fistula recirculation rate (RA)>10%, or an increase of more than 25% compared to the previous examination result] [RA=(SA-A)/(SA-V) * 100, dialysis to 1 hour: SA=blood flow adjusted to 20ml/min, ultrafiltration and dialysate flow stopped, after 2 minutes, artery Blood urea nitrogen concentration A=artery Blood urea nitrogen concentration V=vein Blood urea nitrogen concentration]
6. Abnormal signs of fistula.
Patients with primary Hypercholesterolemia [LDL-C ≥ 130 mg/dl (≥ 3.4 mmol/L), and/or non-HDL-C≥ 160 mg/dl (≥ 4.1 mmol/L)] or combine cardiovascular disease or assess patients with a high risk of cardiovascular disease

Exclusion criteria

MHD with AVG
Breastfeeding or Pregnant Women
Patients with central venous reflux obstruction
Patients with AVF feeding artery disease
Patients with severe Hypotension (systolic blood pressure<90mmHg or diastolic blood pressure<60mmHg, at least three times within one month before signing the informed consent)
Left ventricular Ejection fraction less than 30% or hemodynamic instability
Patients receiving immunotherapy or suspected/confirmed Vasculitis
Patients with coagulation dysfunction or a history of Thrombocytopenic purpura
Patients with vascular access infections or systemic active infections
Patients who are known to be allergic to PCSK9 inhibitors or paclitaxel
Patient's life expectancy is less than 12 months
Patients who are planning kidney transplantation or switching to Peritoneal dialysis
Patients participating in other intervention studies
The researcher judged that the subject's condition was not suitable for participation in this study