Comparative study of safety and effectiveness of rivaroxaban and warfarin in patients with acute deep venous thrombosis

Abstract

Objectives To evaluate the safety and effectiveness of the oral anti-factor Xa (rivaroxaban) in comparison with that of traditional oral (warfarin) anticoagulants in patients in acute stage of deep-vein thrombosis. Background Standard treatment for venous thromboembolism (VTE) consists of a heparin combined with vitamin K antagonists. Direct oral anticoagulants have been investigated for acute and extended treatment of symptomatic VTE; their use could avoid parenteral treatment and/or laboratory monitoring of anticoagulant effects. Patients and methods A prospective study was conducted to compare the efficacy and safety of rivaroxaban (15 mg twice daily for 21 days, followed by 20 mg once daily) with standard therapy (enoxaparin 1.0 mg/kg twice daily and warfarin or acenocoumarol). Patients were treated for 3, 6, or 12 months and followed for suspected recurrent VTE and bleeding. Results Our study included 200 patients in the acute stage of deep venous thrombosis. Half of them were treated by oral anti-factor Xa (rivaroxaban), which showed no significant difference in safety and effectiveness with warfarin. Partial and complete recanalization occurred in 64 and 16%, respectively, for rivaroxaban and in 48 and 24%, respectively, for warfarin, whereas pulmonary embolism and bleeding occurred in 8 and 16%, respectively, for rivaroxaban and 16 and 12%, respectively, for warfarin. Rivaroxaban was noninferior to warfarin with respect to primary efficacy and adverse effect outcome. Conclusion Our study results show nonsignificant difference between oral anti-factor Xa and the Low Molecular Weight Heparin (LMWH) and vitamin K antagonist technique in the treatment of acute stage of deep-vein thrombosis, but the oral anti-factor Xa (rivaroxaban) has an upper hand in being orally taken and needs less monitoring of coagulation profile.