RECORD4
Xarelto® 10 mg once daily in the RECORD4 study demonstrated superior efficacy in VTE prevention compared with enoxaparin 30 mg twice daily, with no increase in risk of bleeding in patients undergoing TKR surgery.69
Key findings from RECORD4
Xarelto demonstrated:69
- Significant reductions in the risk of total VTE and major VTE
- Total VTE (a composite of any DVT, non-fatal PE and all-cause mortality) occurred in 6.9% (67/965) of patients receiving Xarelto and in 10.1% (97/959) of patients receiving enoxaparin (p=0.0118 for superiority)
- A secondary efficacy endpoint, major VTE (a composite of proximal DVT, PE and VTE-related death) occurred in 1.2% (13/1122) of patients receiving Xarelto and in 2.0% (22/1112) of patients receiving enoxaparin (p=0.1237)
- Total VTE (a composite of any DVT, non-fatal PE and all-cause mortality) occurred in 6.9% (67/965) of patients receiving Xarelto and in 10.1% (97/959) of patients receiving enoxaparin (p=0.0118 for superiority)
- A similar safety profile to enoxaparin
- The incidence of major bleeding was very low in both arms of the study: 0.7% (10/1526) and 0.3% (4/1508) of patients receiving Xarelto and enoxaparin, respectively (p=0.1096)
- The combined incidence of major bleeding and non-major clinically relevant bleeding was similar for both treatment groups (3.0% [46/1526] of patients receiving Xarelto group and 2.3% [34/1508] of patients receiving enoxaparin; p=0.1790)
- The incidence of major bleeding was very low in both arms of the study: 0.7% (10/1526) and 0.3% (4/1508) of patients receiving Xarelto and enoxaparin, respectively (p=0.1096)
- 69 - Turpie AGG, Lassen MR, Davidson BL, et al; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009;373(9676):1673-1680
- Efficacy
- The ability of a drug to produce the desired effect.
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
- Deep vein thrombosis
- A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
- Pulmonary embolism
- A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.
