Rivaroxaban versus enoxaparin as thromboprophylaxis in degenerative spine surgery: a randomized blinded non-inferiority study.

PURPOSE

Venous thromboembolism (VTE) is a significant postoperative complication. The most recommended prophylactic measures involve using the unfractionated heparin, and low molecular weight heparins. Since oral anticoagulants can be administered orally and are cost-effective, they have recently gained attention as a newer intervention. This study aimed to compare the effects of rivaroxaban, and enoxaparin thromboprophylaxis in degenerative spine surgeries.

METHOD

Patients diagnosed with degenerative disc disease, and undergoing spinal surgery were randomly assigned to receive either a subcutaneous injection of 40 mg enoxaparin or 10 mg oral rivaroxaban daily in a non-inferiority trial. The evaluation at two weeks, and three months after surgery included the assessments of VTE and other postoperative complications.

RESULT

According to the study protocol, 220 patients were enrolled in the study and included in the intention-to-treat analysis. However, the results were only available for 204 subjects as per-protocol. Ninety-seven in enoxaparin and 107 in rivaroxaban group. VTE was detected in 4 patients (3.6%) in the enoxaparin group, and 2 patients (1.9%) in the rivaroxaban group (P = 0.154). Reoperation rates were significantly higher in the enoxaparin group (P = 0.008). Moreover, the enoxaparin group experienced a significantly longer hospital stay (P = 0.033). However, other outcomes did not show significant differences between two groups (P > 0.05).

CONCLUSION

This study shows that rivaroxaban effectively prevents VTE incidence in degenerative disc spinal surgeries which is non-inferior to enoxaparin in terms of VTE prophylaxis. Furthermore, the patients in the rivaroxaban group experienced shorter hospital stays and a lower necessity for reoperation.