[Evaluation of efficacy and safety of rivaroxaban in the prevention of postoperative venous thromboembolism in adult patients with primary bone tumor undergoing knee operation].

OBJECTIVE

To explore the incidence of postoperative venous thromboembolism (VTE) in adult patients with primary bone tumor undergoing knee operation and evaluate its efficacy and safety in the prevention of VTE.

METHODS

For this prospective, randomized and negative-control single-center trial, a total of 100 eligible patients were selected and randomly divided into observation and control groups. Observation group (rivaroxaban): the first rivaroxaban tablet was taken in the first 24 hours after operation. Rivaroxaban was administered daily every 24 hours up to Day 14.

CONTROL GROUP: no anticoagulant was taken postoperatively.

RESULTS

Efficacy indictors: 6 cases of DVT (an incidence of 12%) occurred in the observation group versus 15 (30%) in the control group. Significant statistical difference existed between two groups (P < 0.05). Furthermore, neither pulmonary embolism nor death was found in either group. Safety indicators:a total of 3 bleeding (1 major and 2 non-major) cases occurred in observation group versus a total of 2 bleeding (no major and 2 non-major) cases in control group. No significant statistical difference existed in bleeding events (P > 0.05). The total incidence of adverse effect was 6% (3/50) in the observation group. The drainage volume of the observation group was a little more than that of the control group. But no significant statistical difference existed in drainage duration (P > 0.05). And there was almost no change in the coagulation system by laboratory examination after oral administration.

CONCLUSION

With an excellent safety profile and a low incidence of adverse effects, Rivaroxaban is effective and safe in the prevention of VTE in adult patients with primary bone tumor undergoing knee operation.