Today the FDA approved the oral anticoagulant Xarelto (rivaroxaban) for DVT prevention in patients undergoing knee or hip replacement surgery. This is good news, as Xarelto has been shown to be effective in preventing DVT and PE and, as an oral drug that does not need routine monitoring of its anticoagulant effect, is easy to take. In the four pivotal clinical phase 3 Rivaroxaban development trials (called RECORD trials), Xarelto (10 mg once daily) was found to be more effective in preventing DVTs and PEs than Enoxaparin[ref 1]: in comparison to Enoxaparin it reduced the composite of symptomatic venous thromboembolism and all-cause mortality after elective total hip and total knee replacement surgery. The risk for major bleeding was the same in the Rivaroxaban and Enoxaparin treated patients (o.3 % versus 0.2 %; p=0.23) [ref 1].
As the risk for venous thromboembolism persists for several weeks after major orthopedic surgery and injections with LMWH or Fondaparinux (Arixtra) for several weeks can be cumbersome for the patient to take, it is nice to now have an effective oral alternative available.
Other Key Studies on Xarelto
Xarelto is NOT approved at this point for treatment of DVT, PE or for atrial fibrillation. For a Clot Connect discussion of the DVT and PE treatment studies – called the EINSTEIN program – and their publication [ref 2] see here.
Understandably, neither of these 2 major guidelines take reference to the new oral anticoagulants, as the latest editions of both were published in 2008.
- American College of Chest Physicians (ACCP): [Geerts WH et al. Chest 2008;133:381S-453S] – link here. New ones are expected to come out at the beginning of 2012.
- American Academy of Orthopedic Surgeons (AAOS): Clinical Guideline; Aug 2008 – link here.
- Turpie AG et al. Rivaroxaban for the prevention of venous thromboembolism after hip and knee arthroplasty. Pooled analysis of four studies. Thromb Haemost, 2011;105:444-453.
- EINSTEIN investigators. Oral Rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010;363:2499-2510.
Disclosures: I have consulted for OthoMcNeil and Bayer, the companies developing Xarelto.
Last updated: July 5th, 2011
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