Comparison of Efficacy and Safety of Rivaroxaban, Heparin, and Enoxaparin in Preventing Thrombosis in Gynaecologic Oncology Surgeries : Thromboprophylaxis in Gyn-oncology Surgery.

BACKGROUND

Background

Background

Venous thromboembolism (VTE) is a frequent and potentially serious complication following gynecologic oncology surgeries. Anticoagulants such as heparin, enoxaparin, and rivaroxaban are commonly used for thromboprophylaxis; however, their comparative efficacy and safety remain uncertain in this patient population.

MATERIALS AND

METHODS

Materials and

Methods

This pilot randomized controlled trial included 85 patients undergoing gynecologic oncology surgery, randomly assigned to receive enoxaparin (n=25), heparin (n=30), or rivaroxaban (n=30). Randomization was performed using block randomization (block size=3) with allocation concealment and double blinding of patients and outcome assessors. The trial was registered in the Iranian Registry of Clinical Trials (IRCT20151020024625N19) and approved by the Ethics Committee of Semnan University of Medical Sciences (IR.SEMUMS.REC.1402.223). Baseline data included age, BMI, cancer type, surgical procedure, and history of vascular events. Outcomes comprised transfusion requirement, dyspnea, chest pain, peripheral edema, lower limb pain, bleeding, infection, hematoma, recovery, and mortality. Data analysis was performed using SPSS v.22 (IBM Corp., Armonk, NY, USA).

RESULTS

Results

Fourteen patients (16.5%) required intraoperative transfusion, with a significantly higher rate in the rivaroxaban group (33.3%) compared to enoxaparin (8.0%) and heparin (6.7%) (P=0.010). Peripheral edema was also more common with rivaroxaban (16.7%) than with heparin (3.3%) or enoxaparin (0%) (P=0.046). Other outcomes showed no significant between-group differences (all P0.05).

CONCLUSION

Conclusions

Rivaroxaban use was linked to increased intraoperative transfusion and short-term edema compared to heparin and enoxaparin. Larger multicenter trials are warranted to confirm these preliminary safety and efficacy findings.