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
; 104(1): 189-200, 2023 07.
Article
in En
| MEDLINE
| ID: mdl-36990214
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.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Arteriovenous Shunt, Surgical
/
Arteriovenous Fistula
/
Angioplasty, Balloon
Type of study:
Clinical_trials
/
Etiology_studies
/
Observational_studies
Limits:
Humans
Language:
En
Journal:
Kidney Int
Year:
2023
Document type:
Article