Safety and efficacy of apixaban versus enoxaparin in gynecologic cancer patients undergoing open surgery: an open-label randomized controlled trial.

BACKGROUND

Women undergoing surgery for gynecologic malignancies are at high risk for postoperative venous thromboembolism (VTE). Although subcutaneous enoxaparin is commonly used for prophylaxis, concerns about cost, self-injections, and adherence have prompted investigation of oral alternatives such as apixaban. In this clinical trial, we compared the safety and efficacy of apixaban versus enoxaparin for postoperative VTE prophylaxis in patients undergoing open surgery for gynecologic cancers.

METHODS

In this single-center, randomized, open-label trial, 450 patients with confirmed gynecologic malignancies undergoing open abdominal surgery were allocated in a 3.5:1 ratio to receive either apixaban (2.5 mg orally twice daily) or enoxaparin (40 mg subcutaneously once daily) for 14–28 days. The primary outcomes were the incidence of VTE and major bleeding within 30 days post‑surgery, corresponding to the active prophylaxis period. Data were analyzed using intention-to-treat principles.

RESULTS

No significant difference was observed in the baseline characteristics of the two study groups. Within 30 days, VTE occurred in 2.0% of patients in the apixaban group and 3.0% in the enoxaparin group (p = 0.891), confirming non-inferiority. Major bleeding events were significantly lower in the apixaban group (1.4%) compared to the enoxaparin group (9.0%) (p = 0.001). No other adverse effects were reported in any of the study groups.

CONCLUSION

Apixaban demonstrated comparable efficacy and superior safety to enoxaparin for postoperative thromboprophylaxis in women undergoing open gynecologic cancer surgery. These findings support apixaban as a viable alternative to enoxaparin in this population. CLINICAL TRIAL NUMBER: IRCT20220211053991N1.