Comparison of apixaban and warfarin in preventing portal vein system thrombosis after laparoscopic splenectomy for cirrhotic patients with secondary hypersplenism: a randomized controlled trial.

BACKGROUND

Portal vein system thrombosis (PVST) is a critical complication after laparoscopic splenectomy (LS). For its treatment, warfarin is widely used in clinical practice, but there are obvious limitations. Apixaban, a novel oral anticoagulant, may offer an alternative treatment option. The objective of this study was to compare the safety and efficacy of apixaban versus warfarin in preventing PVST after LS in cirrhotic patients with secondary hypersplenism.

METHODS

This study was designed as a randomized controlled trial conducted at the Hepatobiliary and Pancreatic Center of our hospital from September 2020 to December 2023. A total of 80 cirrhotic patients who underwent LS were randomly assigned to receive either apixaban or warfarin for a period of 6 months. Generalized estimating equations (GEE) were employed to analyze the impact of different anticoagulant regimens on the incidence of PVST after LS in cirrhotic patients with secondary hypersplenism, as well as to assess the temporal risk of thrombosis.

RESULTS

No adverse events were observed during follow-up. According to GEE, excluding the effect of time, the overall incidence of PVST in the warfarin group was significantly different from that in the apixaban group (31.3% vs. 13.8%; W = 8.217, P = 0.004), and further analysis revealed that the risk of PVST in the warfarin group was significantly higher than in the apixaban group (odds ratio: 3.118, 95% confidence interval: 1.433 to 6.784; P = 0.004). Furthermore, the overall incidence of PVST varied significantly across different time points, demonstrating a consistently decreasing trend over time (W = 21.101, P < 0.001).

CONCLUSION

In the prevention of PVST after LS in cirrhotic patients with secondary hypersplenism, apixaban can be considered as the preferred anticoagulation strategy due to its superior efficacy and similar safety comparable to warfarin.