Drug Eluting Balloon for Early Fistula Failure Trial
Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
Summary
Hemodialysis (HD) remains the most prevalent form of renal replacement therapy (RRT) for
patients with End Stage Renal Disease (ESRD). Loss and dysfunction of vascular access is a
significant contributor to morbidity in ESRD patients on HD. The National Kidney Foundation's
Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines suggest that all ESRD patients
should initiate dialysis with a functioning permanent vascular access with arteriovenous
fistulas (AVF) preferred over arteriovenous grafts (AVG). Central venous catheters (CVC) are
the least preferred vascular access for HD due to the complications associated with them.
Despite these recommendations, up to 80% patients start dialysis with a CVC. One of the
reasons for low AVF rates is early fistula failure (EFF). The most important causes for EFF
amenable to intervention is stenosis anywhere in the circuit. Endovascular approach has shown
a high rate of technical success in the treatment of stenotic lesions related to HD
arteriovenous access. Percutaneous balloon angioplasty (PBA) is considered the treatment of
choice for these lesions. Despite good technical and immediate success PBA has poor long term
outcomes with recurrence rates of 60-70% at 6 months. One of the reasons could be the damage
caused by angioplasty itself leading to intima-media rupture promoting the cascade of events
leading to further development of neo intimal hyperplasia (NIH). Recently the use of covered
stents at the time of angioplasty has shown better patency rates at 6 months but still not
optimal. Lately the development of drug eluting stents and drug eluting balloons (DEB) have
shown considerable advantage in clinical trials related to coronary and peripheral arterial
disease angioplasty. In a randomized control trial, the researchers are planning to assess
the efficacy of DEB angioplasty as compared to standard PBA in AVF's with EFF.