Efficacy and Safety of Apixaban for Prevention of Recurrent Thrombosis after Thrombectomy of Hemodialysis Vascular Access: A Randomized Controlled Trial

Background: Dialysis vascular access thrombosis poses a substantial challenge for individuals undergoing hemodialysis. The efficacy and safety of apixaban, a direct oral Xa inhibitor, in preventing recurrent access thrombosis have yet to be explored. Methods: This was a multi-center randomized control studyregistered at ClinicalTrials.Gov (NCT04489849). The study enrolled hemodialysis patients who underwent successful endovascular thrombectomy within 48 hours. Participants were assigned to standard care or standard care plus apixaban, 2.5mg twice daily for three months. The trial design involved open-label administration, with independent adjudication of endpoints. The primary efficacy endpoint was recurrent access thrombosis within 3 months after thrombectomy. Results: A total of 186 patients were enrolled; 93 patients randomized to the apixaban group and 93 to the control group, with well-balanced baseline characteristics. The apixaban group demonstrated a lower rate of access thrombosis at 3 months than the control group (24.0% vs. 40.8%; hazard ratio, 0.52 [HR]; 95% confidence interval [CI], 0.31-0.88, p=0.01), along with a better primary patency failure rate at 3 months (32.2% vs. 49.5%, HR, 0.57, 95% CI 0.36-0.91, P=0.02). Safety outcomes showed comparable death rates and major bleeding incidents but higher incidence of minor bleeding in the apixaban group (22.6% vs. 7.5%, p=0.01). The effect of apixaban did not show interaction in subgroups of different access types, antiplatelet usage, or history of thrombosis. Conclusion: Apixaban effectively reduces the risk of recurrent thrombosis in hemodialysis vascular access. Despite a minor increase in bleeding adverse effects, the net clinical benefit supports the use of apixaban in this context. Funding: Government Support – Non-U.S. Efficacy outcomes - Outcomes Hazard Ratio 95% CI(LB) 95% CI(UB) P value Access thrombosis at 3 mo 0.52 0.31 0.88 0.01 Primary patency failure at 3 mo 0.57 0.36 0.91 0.02 Secondary patency failure at 3 mo 2.55 0.49 13.1 0.26 Access thrombosis at 6 mo 0.63 0.41 0.98 0.04 Primary patency failure at 6 mo 0.65 0.44 0.96 0.03 Secondary patency failure at 6 mo 1.70 0.41 7.12 0.47