Prospective Randomized Trial Comparing DEB Versus Conventional PTA for the Treatment of Hemodialysis AVF or AVG Stenoses (DEBAPTA)

Singapore Health Services (SingHealth)

Status: Completed

Conditions: Stenosis of Arteriovenous Dialysis Fistula; Arteriovenous Graft Stenosis

Treatments: Device: Drug Eluting Balloon (DEB); Device: Conventional PTA

Study type: Interventional

Funder types: Other

Identifiers

NCT01544907

DEBAPTA

Details and patient eligibility

About

A prospective randomized trial comparing the efficacy of drug eluting balloon angioplasty versus conventional percutaneous transluminal angioplasty balloon for the treatment of hemodialysis arterio-venous fistula or arterio-venous graft stenoses in reducing late luminal loss and restenosis rates, while prolonging primary and secondary patencies.

Full description

Introduction:

Neointimal hyperplasia is the main cause of hemodialysis access [arterio-venous fistula (AVF) or graft (AVG)] dysfunction and thrombosis. Although endovascular techniques like percutaneous transluminal angioplasty (PTA), catheter directed thrombolysis, mechanical thrombectomy or bare metal stenting, may salvage the access, long term patency remains dismal due to recurrent stenosis from neointimal hyperplasia.

Drug Eluting Balloon (DEB) is effective in inhibiting neointimal hyperplasia for treatment of coronary in-stent restenosis since 2006 and more recently in femoropopliteal arteries, reducing restenosis rates and prolonging patency.

Specific Aim:

To determine the efficacy of DEB in reducing restenosis rates and prolonging the patency of AVFs/AVGs compared to PTA.

Hypothesis:

DEB is superior to PTA in reducing late luminal loss and restenosis rates, while prolonging primary and secondary patencies.

Methodology:

Prospective, randomized clinical trial with study population comprising of patients with dysfunctional AVFs/AVGs due to underlying stenoses. The patients will be randomized to receive either DEB or PTA.

The 6-month late luminal loss will be primary endpoint. The secondary endpoints of restenosis rate, primary and secondary patencies, will also be determined.

Major Clinical Significance:

Hemodialysis access failures constitute significant morbidity and costs to patient and healthcare system. Maintaining access patency consumes significant resources and constitutes a significant portion of the work of vascular surgeons, nephrologists and interventional radiologists.

Any strategy that reduces access failure or prolonging access lifespan will be beneficial. If DEB is proven to be superior to PTA, there will be a paradigm shift in management of hemodialysis access failures from restenosis - similar to how DEB has changed practice in managing coronary artery in-stent restenosis.

Enrollment: 125 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Upper limb or groin AVF/AVG
2. The AVF/AVG is > 3 months old.
3. Native vessel measures between 4 to 7 mm diameter (corresponding to the sizes of available DEBs).
4. The fistula or graft must not be thrombosed.
5. Able to cross with guide wire
6. Platelet count >50,000/l (platelet infusion if <100,000/l)
7. PT/PTT not more than 3 seconds above normal (FFP infusion for abnormal PT/PTT)

Exclusion criteria

1. Uncorrectable coagulopathy (despite transfusion) or hypercoagulable state.
2. Evidence of systemic infection or a local infection associated with the fistula or graft.
3. The patient is < 21 years of age.
4. The patient is pregnant.
5. Patient is enrolled in another investigational study
6. Patient has comorbid conditions that may limit their ability to comply with the follow-up requirement.
7. Life expectancy < 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 2 patient groups

Conventional PTA only

Active Comparator group

Description:

Treatment Arm 1- Conventional PTA only The conventional balloon is used and the diameter of the balloon should be the same or oversized by 1mm the diameter of the reference vessel. An inflation device with a pressure gauge is used to inflate up to manufacturers' stated burst pressure. The duration of balloon inflation will be 2 minutes. At the end of the first angioplasty, an AVFistulogram/AVGraftogram will be obtained to document results. If there is residual stenosis of \>30%, a repeat angioplasty using the same balloon or another appropriately oversized balloon by 1mm will be used for an additional 2 minutes. A final angiogram will be obtained for documentation.

Treatment:

Device: Conventional PTA

Drug Eluting Balloon (DEB)

Experimental group

Description:

Treatment arm 2 - Conventional Balloon with DEB A Conventional balloon is used to pre-dilate the target lesion. The DEB of a similar diameter to the conventional balloon used is then inflated across the stenosis. An inflation device with a pressure gauge is used to inflate up to manufacturers' stated burst pressure. The duration of balloon inflation will be 1 minute. A final angiogram will be obtained for documentation. The drug coated on the DEB is Paclitaxel.

Treatment:

Device: Drug Eluting Balloon (DEB)