Six-month safety and efficacy outcomes from the randomized-controlled arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) trial.
In patients whose dialysis fistula had narrowed, a covered stent-like device kept the treated segment open far more often at six months than standard balloon angioplasty, with no extra safety events in the first month.
Background
Stenosis within the arteriovenous fistula causes vascular access dysfunction and inadequate haemodialysis. Percutaneous transluminal angioplasty (PTA) is the standard treatment, but restenosis and subsequent loss of access patency remain common. Whether a cell-impermeable endoprosthesis (CIE) improves on PTA in this setting had not previously been tested.
Study design
WAVE was a prospective, international, multicentre pivotal trial across 43 centres. A total of 245 patients with stenosis in the venous outflow circuit were randomized to CIE (n=122) or PTA (n=123). Co-primary endpoints were six-month target lesion primary patency — freedom from clinically driven target lesion revascularization or thrombosis — and freedom from safety events through 30 days post-procedure that affected the access circuit and led to reintervention, hospitalization or death. Access circuit primary patency was a secondary efficacy endpoint.
Key findings
Six-month target lesion primary patency was 89.6% with CIE versus 62.3% with PTA, and access circuit primary patency was 72.2% versus 57.0%, both significantly favouring the device. At 30 days there was no statistically significant difference in freedom from safety events (96.6% CIE versus 95.0% PTA), and no differences in adverse events were observed between cohorts.
Clinical implications
For patients with outflow stenosis threatening a functioning access, these data support the endoprosthesis as superior to angioplasty for maintaining patency over six months without an early safety penalty. Longer follow-up is needed before the device can be positioned as a default over PTA, particularly given the repeat-intervention economics and the absence of reported effects on dialysis adequacy or mortality.
Category
Research
Source
Kidney International
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