Rivaroxaban versus enoxaparin for treatment of patients with nonhematologic cancer with venous thromboembolism a randomized clinial trial

Background: Low-Molecular-Weight Heparin (LMWH) is recommended as the first-line treatment in patients with active cancer and venous thromboembolism (VTE), but many patients prefer to take oral anticoagulants and non-injectable forms with more reasonable price. Venous thromboembolism is a very common comorbidity in patients with cancer. Therefore, the aim of this study was to evaluate the efficacy and safety of the rivaroxaban compared with enoxaparin in patients with cancer and VTE. Methods: This randomized clinical trial was conducted on 50 patients with non-hematologic cancer and deep vein thrombosis (DVP) or pulmonary thromboembolism (PTE) enrolled into Imam Khomeini hospital, from November 2019 to March 2020 in Ahvaz. The participants randomly assigned in two treatment groups (25 patients in each group) of rivaroxaban (15 mg every 12 hours for the first three weeks and then orally at 20 mg daily) or enoxaparin (1 mg/kg by subcutaneous injection every 12 hours) and followed for 6 months to evaluate the efficacy, complications and safety (incidence of recurrent VTE, major bleeding and deaths) of these therapies in Ahvaz. Results: The three most common cancer diagnoses were breast (n=11, 22%), colon (n=10, 20%), and lung (n=7, 14%). Major bleeding at 6 months was only seen in one patient (4%) in the enoxaparin group and did not occur in the rivaroxaban group (P>0.05). Minor bleeding occurred in 1 patient (4%) in the rivaroxaban group and did not occur in the enoxaparin group (P>0.05). One patient in the enoxaparin group died because of fever and neutropenia. The prevalence of DVT and PTE in cancer patients was not significantly different based on patient age (P=0.154), gender (P=0.430), BMI (P=0.490), underlying disease (P=0.294), smoking (P=0.955), type of cancer (P=0.527), and metastatic cancer (P=0.280). Conclusion: The results of this study suggest that the efficacy of rivaroxaban is not less than that of enoxaparin and therefore can be a potential option for patients with non-hematologic cancer and VTE. However, further randomized, controlled trials are needed to confirm these results.