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 Jul;104(1):189-200. doi: 10.1016/j.kint.2023.03.015. Epub 2023 Mar 27.

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.

Trial registration: ClinicalTrials.gov NCT02649946.

Keywords: arteriovenous covered stent; arteriovenous fistula; hemodialysis access.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Angioplasty / adverse effects
  • Angioplasty, Balloon* / adverse effects
  • Arteriovenous Fistula* / etiology
  • Arteriovenous Shunt, Surgical* / adverse effects
  • Constriction, Pathologic / etiology
  • Graft Occlusion, Vascular / diagnostic imaging
  • Graft Occlusion, Vascular / etiology
  • Graft Occlusion, Vascular / therapy
  • Humans
  • Prospective Studies
  • Renal Dialysis / adverse effects
  • Stents
  • Treatment Outcome
  • Vascular Patency

Associated data

  • ClinicalTrials.gov/NCT02649946