Apixaban for the Prevention of Tunneled Cuffed Catheter Thrombosis in Hemodialysis Patients: A Randomized Controlled Trial

Abstract

Background: Tunneled cuffed catheters (TCCs) provide essential vascular access for patients with end-stage kidney disease undergoing maintenance hemodialysis; however, they remain highly susceptible to thrombotic occlusion and subsequent failure. Objectives: This investigation evaluated the clinical efficacy and safety of low-dose oral apixaban for the prophylaxis of TCC-associated thrombosis and flow dysfunction. Methods: A double-blind, randomized controlled trial was conducted involving 100 adult patients requiring newly inserted TCCs at Imam Khomeini Hospital in Urmia, Iran, between 2023 and 2024. Participants were allocated in a 1:1 ratio to receive either 2.5 mg of oral apixaban daily or standard care for 6 months. The primary endpoint was catheter dysfunction, defined as a blood flow rate below 300 mL/min. Secondary outcomes included bleeding events and catheter replacement interventions. Results: Baseline clinical characteristics were well balanced between the two arms. Apixaban administration was associated with a statistically significant reduction in the rate of TCC thrombosis (8% vs 28%; P = 0.0196) and a reduced requirement for catheter replacement (6% vs 20%; P = 0.0353). Bleeding events did not differ significantly between the groups (2% vs 6%; P = 0.6098), and no major bleeding episodes were recorded. Conclusions: Prophylactic low-dose oral apixaban significantly reduced TCC-related thrombotic dysfunction and decreased catheter exchange rates in patients receiving chronic hemodialysis, demonstrating a favorable short-term safety profile without excessive bleeding. However, given the limited sample size, these findings should be interpreted with caution. Large-scale, multicenter randomized trials are needed to confirm these preliminary results and establish long-term clinical safety before routine adoption.