Comparative Efficacy and Safety of Dabigatran, Enoxaparin, and Rivaroxaban for Prophylaxis of Cancer-associated Venous Thromboembolism:A Single-center Randomized Trial

Introduction: The objective of this study was to compare the prophylactic efficacy of enoxaparin, dabigatran, and rivaroxaban in ambulatory patients with cancer. Methods: In this randomized trial, patients were assigned to three groups: Group 1 received subcutaneous enoxaparin 40 mg daily (n = 35), Group 2 received oral dabigatran 150 mg daily (n = 11), and Group 3 received oral rivaroxaban 10 mg daily (n = 11) for a duration of three months. The primary outcomes were the incidence of Venous Thromboembolism (VTE) and bleeding events. Results: The incidence of VTE was 2 (3.5%) in patients receiving enoxaparin and 1 (1.7%) in those receiving dabigatran (P > 0.05). No thromboembolic events were reported in patients administered rivaroxaban. One patient (1.7%) in the enoxaparin group experienced a major bleeding episode (P > 0.05), while no major bleeding events were observed in patients receiving dabigatran or rivaroxaban. Discussion: Enoxaparin, dabigatran, and rivaroxaban are widely used for the prevention of VTE in patients with cancer. Although some previous studies have reported differences in bleeding and VTE risk, the present study did not demonstrate significant differences among enoxaparin, dabigatran, and rivaroxaban in VTE prevention. Notably, the risk of VTE is substantially influenced by the type of cancer, the modalities of anticancer treatment, and the patient’s clinical status. Conclusion: The efficacy and safety of enoxaparin, dabigatran, and rivaroxaban for the prevention of VTE in patients with cancer appear to be comparable. Clinical Trial Number: Iranian Registry of Clinical Trials (IRCT20200407046984N1).