RECORD1
Xarelto® 10 mg once daily in the RECORD1 study demonstrated superior VTE prevention to enoxaparin 40 mg once daily, with no significant increase in risk of bleeding in patients undergoing THR surgery. 5
Key findings from RECORD1
Xarelto demonstrated, in comparison with enoxaparin:2
- 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 1.1% (18/1595) of patients receiving Xarelto and in 3.7% (58/1558) of patients receiving enoxaparin (p<0.001 for superiority)
- A secondary efficacy endpoint, major VTE (a composite of proximal DVT, PE and VTE-related death) occurred in 0.2% (4/1686) of patients receiving Xarelto and in 2.0% (33/1678) of patients receiving enoxaparin (p<0.001 for superiority)
- Total VTE (a composite of any DVT, non-fatal PE and all-cause mortality) occurred in 1.1% (18/1595) of patients receiving Xarelto and in 3.7% (58/1558) of patients receiving enoxaparin (p<0.001 for superiority)
- A similar safety profile
- The incidence of major bleeding was very low in both arms of the study: 0.3% (6/2209) and 0.1% (2/2224) of patients receiving Xarelto and enoxaparin, respectively (p=0.18)
- The combined incidence of major bleeding and non-major clinically relevant bleeding was similar for both treatment groups (3.2% [70/2209] of patients receiving Xarelto and 2.5% [56/2224] of patients receiving enoxaparin; absolute increase in risk, 0.6%; 95% CI –0.4 to 1.6)
- The incidence of major bleeding was very low in both arms of the study: 0.3% (6/2209) and 0.1% (2/2224) of patients receiving Xarelto and enoxaparin, respectively (p=0.18)
- 5 - Anderson FA Jr, Zayaruzny M, Heit JA, Fidan D, Cohen AT. Estimated annual numbers of US acute-care hospital patients at risk for venous thromboembolism. Am J Hematol. 2007;82(9):777-782.
- 2 - Eriksson BI, Borris LC, Friedman RJ, et al; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765-2775.
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
- Efficacy
- The ability of a drug to produce the desired effect.
- 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.
