Key result
Rivaroxaban and standard therapy both resulted in 0% recurrent venous thromboembolism, with bleeding events occurring in 25% of rivaroxaban patients versus 40% of standard therapy patients.
Why the study?
Does subcutaneous enoxaparin followed by oral rivaroxaban prevent recurrent venous thromboembolism compared to enoxaparin followed by warfarin in patients with acute deep-vein thrombosis?
RCT (n=40)
Open-label
parallel group
Does subcutaneous enoxaparin followed by oral rivaroxaban prevent recurrent venous thromboembolism compared to enoxaparin followed by warfarin in patients with acute deep-vein thrombosis?
Absolute Event Rate: 0% vs 0%
In a small trial of acute DVT patients, a regimen of enoxaparin followed by rivaroxaban prevented recurrent VTE similarly to standard enoxaparin/warfarin therapy, with numerically fewer bleeding events.
Rivaroxaban matches warfarin for recurrent VTE prevention in acute DVT with numerically fewer bleeds; reinforces NOAC preference in this setting.
Background Rivaroxaban is the first oral anticoagulant drug that is a direct inhibitor of activated factor X (FXa) of clotting which may provide a simple, fixed-dose regimen for treating acute deep-vein thrombosis (DVT) without the need for laboratory monitoring. Method An opened label randomized parallel group clinical trial compared subcutaneous enoxaparin 1 mg/ kg once daily for 5 days followed by oral rivaroxaban 20 mg once daily with subcutaneous enoxaparin 1 mg/ kg once daily followed by a vitamin K antagonist (warfarin) for 2 month of treatment. The primary efficacy outcome for both was recurrent venous thromboembolism (VTE). The principal safety outcome was major bleeding or clinically relevant non major bleeding. Results Out of the 20 patients in the rivaroxaban group, 5 patients (25%) developed bleeding events while in the standard therapy group 8 out of 20 patients, 40 % developed bleeding events. Moreover, 10 patients in the rivaroxaban group (50%) developed adverse drug reactions versus 14 patients (70%) in the standard therapy group. However, none of the patients in both groups developed recurrent VTE neither DVT nor pulmonary embolism (PE).
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Neven Sarhan (2015) conducted an RCT in acute deep-vein thrombosis (DVT) (n=40). Rivaroxaban vs. subcutaneous enoxaparin 1 mg/kg once daily followed by a vitamin K antagonist (warfarin) was evaluated on recurrent venous thromboembolism (VTE). Rivaroxaban and standard therapy both resulted in 0% recurrent venous thromboembolism, with bleeding events occurring in 25% of rivaroxaban patients versus 40% of standard therapy patients.
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