Superior efficacy in VTE prevention after elective hip and knee replacement surgery with no increase in bleeding

RECORD (REgulation of Coagulation in ORthopaedic surgery to prevent Deep vein thrombosis and pulmonary embolism) comprised four randomized, double-blind clinical studies of Xarelto® in more than 12,500 patients undergoing elective THR or elective TKR surgery.105
Xarelto given as a single 10 mg tablet once daily was compared with subcutaneous enoxaparin given once daily (40 mg) or twice daily (30 mg) for the prevention of VTE in patients undergoing elective THR or TKR surgery.

RECORD12 and RECORD23 studied Xarelto in THR:


  • RECORD1 compared Xarelto 10 mg once daily with enoxaparin 40 mg once daily for a treatment period of 35±4 days
  • RECORD2 compared extended-duration (35±4 days) Xarelto 10 mg once daily with short-duration (12±2 days) enoxaparin 40 mg once daily followed by placebo

RECORD34 and RECORD469 studied Xarelto in TKR:


  • RECORD3 compared Xarelto 10 mg once daily with enoxaparin 40 mg once daily once daily for a treatment period of 12±2 days
  • RECORD4 compared Xarelto 10 mg once daily with enoxaparin 30 mg twice daily for a treatment period of 12±2 days

The RECORD studies defined a new standard for the prevention of VTE in patients undergoing THR or TKR surgery.
  • Xarelto demonstrated superior efficacy to enoxaparin 40 mg once daily or 30 mg twice daily with similar rates of bleeding{5–8}
  • Xarelto is a convenient, oral, once-daily regimen for VTE prevention in patients undergoing THR or TKR surgery{5–8}
  • Thromboprophylaxis with Xarelto compared with enoxaparin can realize significant cost savings per patient, with marked cost savings for healthcare systems.

The RECORD1 Study >
  • 105 - Turpie AGG, Lassen MR, Eriksson BI et al. Rivaroxaban for the prevention of venous thromboembolism after hip or knee arthroplasty. Pooled analysis of four studies. Thromb Haemost 2011;105:444–453.
  • 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.
  • 3 - Kakkar AK, Brenner B, Dahl OE, et al; RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008;372(9632):31-39.
  • 4 - Lassen MR, Ageno W, Borris LC, et al; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358(26):2776-2786.
  • 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
Thrombosis
Formation of a clot inside a blood vessel.
Subcutaneous
Introduced beneath the skin.
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.

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