Venous Thromboembolism│Prevention, Prophylaxis, and Vein Thrombosis

Venous Thromboembolism (VTE)

Thromboembolic disorders are a major cause of morbidity and mortality worldwide. Venous thromboembolism (VTE), which includes both deep vein thrombosis (DVT) and pulmonary embolism (PE), is the third most common cardiovascular disorder after ischaemic heart disease and stroke, and is estimated to contribute to about 10% of all deaths that occur in the hospital.6, 37

Venous thromboembolism (VTE) is the immediate cause of death in about 10% of patients who die in the hospital.5 Major orthopaedic surgery, such as hip and knee replacement surgery, is associated with a high incidence of post-operative VTE.6

Xarelto® was found in clinical studies to be significantly more effective in preventing venous blood clots, with a similar and low level of bleeding compared to enoxaparin in preventing VTE in adult patients undergoing elective hip or knee replacement surgery. (Note: RECORD2 compared extended-duration (5 weeks) Xarelto® to short-term (2 weeks) enoxaparin.)2, 3, 4

Venous Thromboembolism (VTE) Prevention

While current guidelines recommend pharmacological VTE prevention for patients undergoing such surgery, a significant number of patients undergoing major orthopaedic surgery are not getting preventive treatment.7

The methods for preventing VTE can be divided into 2 categories: mechanical and pharmaceutical. Recent guidelines recommend the routine use of antithrombotic agents for surgical patients at highest risk of VTE (eg, those undergoing elective hip replacement or knee replacement surgery).

These guidelines are considered by many to be the “gold standard” for preventing thromboembolism.

The guidelines also say that mechanical methods (such as compression stockings) should be used primarily in patients who are at high risk of bleeding or in addition to antithrombotic therapy.6

Xarelto® is the first direct oral Factor Xa inhibitor (approved in the European Union for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery), a new generation of investigational anticoagulants targeting the prevention and treatment of acute and chronic thromboembolic diseases. Extensive studies already involve more than 32,000 patients, and more than 60,000 patients are expected to be evaluated when the studies are completed. This establishes Xarelto® as the most studied anticoagulant of its kind to date.64, 68

Vein Thrombosis

Major orthopaedic surgery involving the lower extremity — hip or knee replacement surgery or hip fracture surgery — is associated with a high risk of venous thromboembolism (VTE). The risk results from stasis of venous blood flow as well as direct injury to the veins during surgery.43

Undertreatment remains a problem, despite ample evidence that primary preventive therapy effectively reduces the risk of deep vein thrombosis (DVT), pulmonary embolism (PE), and fatal PE.6, 7

  • 6 - Geerts WH, Bergqvist D, Pineo GF, et al. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133(6 suppl):381S-453S.
  • 37 - Sandler DA. Martin JF. Autopsy proven pulmonary embolism in hospital patients: are we detecting enough deep vein thrombosis? J R Soc Med. 1989;82(4):203-205.
  • 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.
  • 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.
  • 7 - Cohen AT, Tapson VF, Bergmann JF, et al; ENDORSE Investigators. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study. Lancet. 2008;371(9610):387-394.
  • 64 - Bayer’s Novel Anticoagulant Rivaroxaban Submitted for Approval in the U.S. [press release] Available at http://www.viva.vita.bayerhealthcare.com/index.php?id=36&tx_ttnews[tt_news]=12625&cHash=97a2ea4a90
  • 68 - U.S. FDA Advisory Committee supports favorable benefit-risk profile of Bayer’s rivaroxaban [press release] Available at http://www.press.bayer.com/baynews/baynews.nsf/id/2A95822BEA3213E7C125757E0074EC47?Open
  • 43 - Merli GJ. Pathophysiology of venous thrombosis, thrombophilia, and the diagnosis of deep vein thrombosis-pulmonary embolism in the elderly. Clin Geriatr Med. 2006;22(1):75-92.