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SHR Neuro Cancer Cardio Lipid Metab Microb

Dolmatch, B; Cabrera, T; Pergola, P; Balamuthusamy, S; Makris, A; Cooper, R; Moore, E; Licht, J; Macaulay, E; Maleux, G; Pfammatter, T; Settlage, R; Cristea, E; Lansky, A, , AVeNEW, Trial, Investigators.
Prospective, randomized, multicenter clinical study comparing a self-expanding covered stent to percutaneous transluminal angioplasty for treatment of upper extremity hemodialysis arteriovenous fistula stenosis.
Kidney Int. 2023; 104(1): 189-200. Doi: 10.1016/j.kint.2023.03.015
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Deutschmann Hannes

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Abstract:

Use of a covered stent after percutaneous transluminal angioplasty (PTA) was compared to PTA alone for treatment of upper extremity hemodialysis patients with arteriovenous fistula (AVF) stenoses. Patients with AVF stenosis of 50% or more and evidence of AVF dysfunction underwent treatment with PTA followed by randomization of 142 patients to include a covered stent or 138 patients with PTA alone. Primary outcomes were 30-day safety, powered for noninferiority, and six-month target lesion primary patency (TLPP), powered to test whether TLPP after covered-stent placement was superior to PTA alone. Twelve-month TLPP and six-month access circuit primary patency (ACPP) were also hypothesis tested while additional clinical outcomes were observed through two years. Safety was significantly non-inferior while six- and 12-month TLPP were each superior for the covered stent group compared to PTA alone (six months: 78.7% versus 55.8%; 12 months: 47.9% versus 21.2%, respectively). ACPP was not statistically different between groups at six-months. Observed differences at 24 months favored the covered-stent group: 28.4% better TLPP, fewer target-lesion reinterventions (1.6 ± 1.6 versus 2.8 ± 2.0), and a longer mean time between target-lesion reinterventions (380.4 ± 249.5 versus 217.6 ± 158.4 days). Thus, our multicenter, prospective, randomized study of a covered stent used to treat AVF stenosis demonstrated noninferior safety with better TLPP and fewer target-lesion reinterventions than PTA alone through 24 months.

Find related publications in this database (using NLM MeSH Indexing)

Humans - administration & dosage

Graft Occlusion, Vascular - diagnostic imaging, etiology, therapy

Vascular Patency - administration & dosage

Constriction, Pathologic - etiology

Angioplasty, Balloon - adverse effects

Prospective Studies - administration & dosage

Treatment Outcome - administration & dosage

Arteriovenous Shunt, Surgical - adverse effects

Angioplasty - adverse effects

Stents - administration & dosage

Arteriovenous Fistula - etiology

Renal Dialysis - adverse effects

Find related publications in this database (Keywords)

arteriovenous covered stent

arteriovenous fistula

hemodialysis access

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