Efficacy of direct oral anticoagulants in the prophylaxis of catheter-related thrombosis: The DOACAT study

Background and aim: Catheter-associated thrombosis is a frequent cause of tunneled catheter dysfunction, and evidence for prophylactic anticoagulation with direct oral anticoagulants is limited. This study evaluated the efficacy and safety of apixaban and rivaroxaban in preventing catheter-associated thrombosis and improving catheter survival. Methods: A prospective randomized controlled trial was conducted at a tertiary referral center from January 2022 to December 2024. A total of 477 patients requiring permanent venous catheters were randomized into three groups: Group A (Apixaban 2.5 mg twice daily), Group B (Rivaroxaban 10 mg once daily), and Group C (placebo). Patients were followed by duplex ultrasonography at 1 week, 1-, 3-, 6-, and 12-months post-catheterization. The primary outcome was the incidence of tunneled catheter–associated thrombosis (CAT). Secondary outcomes included catheter survival and complication rates. Results: Catheter-associated thrombosis occurred significantly less frequently in the apixaban (8.6%) and rivaroxaban (11.9%) groups than in the placebo group (33.3%) ( p  < 0.001). Both DOAC groups demonstrated significantly improved catheter survival compared with placebo on Kaplan–Meier analysis (log-rank p  < 0.001), with no significant difference between apixaban and rivaroxaban. On multivariable logistic and Cox regression analyses, DOAC use was independently associated with a reduced risk of catheter-associated thrombosis and loss of catheter access, whereas chemotherapy was associated with higher risk. Catheter-related complications, including malfunction, infection, and limb deep venous thrombosis, occurred more frequently in the placebo group. No major or clinically relevant non-major bleeding events were observed during follow-up. Conclusion: Prophylactic use of apixaban or rivaroxaban significantly reduces catheter-associated thrombosis and prolongs catheter survival compared with placebo, without an increased risk of bleeding. These findings support the efficacy and safety of selective prophylactic DOAC use in patients with tunneled central venous catheters and warrant further multicenter studies to confirm their role in routine clinical practice.