FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |   Search Term  Advanced Search

Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe

Previous Volume 345:1298-1304 November 1, 2001 Number 18 Next

	Full Text PDF Editorial by Diuguid, D. L. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited Related Article PubMed Citation

ABSTRACT

Background Surgery for hip fracture carries a high risk of venous thromboembolism, despite the use of current thromboprophylactic treatments. Fondaparinux, a synthetic pentasaccharide, is a new antithrombotic agent that may reduce this risk.

Methods In a double-blind study, we randomly assigned 1711 consecutive patients undergoing surgery for fracture of the upper third of the femur to receive subcutaneous doses of either 2.5 mg of fondaparinux once daily, initiated postoperatively, or 40 mg of enoxaparin once daily, initiated preoperatively, for at least five days. The primary efficacy outcome was venous thromboembolism up to postoperative day 11. Venous thromboembolism was defined as deep-vein thrombosis detected by mandatory bilateral venography, documented symptomatic deep-vein thrombosis, or documented symptomatic pulmonary embolism. The main safety outcomes were major bleeding and mortality from all causes. The duration of follow-up was six weeks.

Results The incidence of venous thromboembolism by day 11 was 8.3 percent (52 of 626 patients) in the fondaparinux group and 19.1 percent (119 of 624 patients) in the enoxaparin group (P<0.001). The reduction in risk with fondaparinux was 56.4 percent (95 percent confidence interval, 39.0 to 70.3 percent). There were no significant differences between the two groups in the incidence of death or clinically relevant bleeding.

Conclusions In patients undergoing surgery for hip fracture, fondaparinux was more effective than enoxaparin in preventing venous thromboembolism and was equally safe.

Source Information

From the Department of Orthopedics, Sahlgrenska University Hospital–Östra, Göteborg, Sweden (B.I.E.); the Department of Medicine, Veterans Affairs Boston Healthcare System and Beth Israel Deaconess Medical Center, Boston (K.A.B.); the Department of Orthopedics, Hillerød University, Hillerød, Denmark (M.R.L.); and the Department of Medicine, Hamilton Health Sciences Corporation–General Division, Hamilton, Ont., Canada (A.G.G.T.).

Address reprint requests to Dr. Eriksson at the Orthopedics Department, Sahlgrenska University Hospital–Östra, S-41685 Göteborg, Sweden, or at b.eriksson{at}orthop.gu.se.

Full Text of this Article

This article has been cited by other articles:

• Camporese, G., Bernardi, E., Prandoni, P., Noventa, F., Verlato, F., Simioni, P., Ntita, K., Salmistraro, G., Frangos, C., Rossi, F., Cordova, R., Franz, F., Zucchetta, P., Kontothanassis, D., Andreozzi, G. M., for the KANT (Knee Arthroscopy Nadroparin Thrombop, (2008). Low-Molecular-Weight Heparin versus Compression Stockings for Thromboprophylaxis after Knee Arthroscopy: A Randomized Trial. ANN INTERN MED 149: 73-82 [Abstract] [Full Text]  
• Eriksson, B. I., Borris, L. C., Friedman, R. J., Haas, S., Huisman, M. V., Kakkar, A. K., Bandel, T. J., Beckmann, H., Muehlhofer, E., Misselwitz, F., Geerts, W., the RECORD1 Study Group, (2008). Rivaroxaban versus Enoxaparin for Thromboprophylaxis after Hip Arthroplasty. NEJM 358: 2765-2775 [Abstract] [Full Text]  
• Hirsh, J., Bauer, K. A., Donati, M. B., Gould, M., Samama, M. M., Weitz, J. I. (2008). Parenteral Anticoagulants: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 133: 141S-159S [Abstract] [Full Text]  
• Geerts, W. H., Bergqvist, D., Pineo, G. F., Heit, J. A., Samama, C. M., Lassen, M. R., Colwell, C. W. (2008). Prevention of Venous Thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 133: 381S-453S [Abstract] [Full Text]  
• Turpie, A. G.G. (2008). Selective factor Xa inhibition with fondaparinux: from concept to clinical benefit. Eur Heart J Suppl 10: C1-C7 [Abstract] [Full Text]  
• Eikelboom, J. W. (2008). Effect of fondaparinux 2.5 mg once daily on mortality: a meta-analysis of phase III randomized trials of venous thromboembolism prevention. Eur Heart J Suppl 10: C8-C13 [Abstract] [Full Text]  
• Singelyn, F. J., Verheyen, C. C.P.M., Piovella, F., Van Aken, H. K., Rosencher, N., for the EXPERT Study Investigators, (2007). The Safety and Efficacy of Extended Thromboprophylaxis With Fondaparinux After Major Orthopedic Surgery of the Lower Limb With or Without a Neuraxial or Deep Peripheral Nerve Catheter: The EXPERT Study. Anesth. Analg. 105: 1540-1547 [Abstract] [Full Text]  
• Shorr, A. F., Sarnes, M. W., Peeples, P. J., Stanford, R. H., Happe, L. E., Farrelly, E. (2007). Comparison of cost, effectiveness, and safety of injectable anticoagulants used for thromboprophylaxis after orthopedic surgery. Am J Health Syst Pharm 64: 2349-2355 [Abstract] [Full Text]  
• Sidhu, P S, Alikhan, R, Ammar, T, Quinlan, D J (2007). Lower limb contrast venography: a modified technique for use in thromboprophylaxis clinical trials for the accurate evaluation of deep vein thrombosis. Br. J. Radiol. 80: 859-865 [Abstract] [Full Text]  
• Leizorovicz, A., SMART Venography Study Steering Committee, (2007). Epidemiology of post-operative venous thromboembolism in Asian patients. Results of the SMART venography study. haematol 92: 1194-1200 [Abstract] [Full Text]  
• Rogers, F., Rebuck, J. A., Sing, R. F. (2007). Venous Thromboembolism in Trauma: An Update for the Intensive Care Unit Practitioner. J Intensive Care Med 22: 26-37 [Abstract]  
• Singh Mangat, K., Mehra, A., Yunas, I., Porter, K. (2006). Venous thromboprophylaxis in trauma: a review. Trauma 8: 233-247 [Abstract]  
• Nutescu, E. A, Wittkowsky, A. K, Dobesh, P. P, Hawkins, D. W, Dager, W. E (2006). Choosing the Appropriate Antithrombotic Agent for the Prevention and Treatment of VTE: A Case-Based Approach. The Annals of Pharmacotherapy 40: 1558-1570 [Abstract] [Full Text]  
• Piazza, G., Goldhaber, S. Z. (2006). Acute Pulmonary Embolism: Part II: Treatment and Prophylaxis. Circulation 114: e42-e47 [Full Text]  
• Bauer, K. A. (2006). New Anticoagulants. ASH Education Book 2006: 450-456 [Abstract] [Full Text]  
• Hasan, J., Shnyder, S. D., Clamp, A. R., McGown, A. T., Bicknell, R., Presta, M., Bibby, M., Double, J., Craig, S., Leeming, D., Stevenson, K., Gallagher, J. T., Jayson, G. C. (2005). Heparin Octasaccharides Inhibit Angiogenesis In vivo. Clin. Cancer Res. 11: 8172-8179 [Abstract] [Full Text]  
• Lieberman, J. R., Hsu, W. K. (2005). Prevention of Venous Thromboembolic Disease After Total Hip and Knee Arthroplasty. JBJS 87: 2097-2112 [Abstract] [Full Text]  
• Karnik, L., Murray, J. (2005). Anticoagulation in the trauma patient. Trauma 7: 63-68 [Abstract]  
• Mehta, S. R., Steg, P. G., Granger, C. B., Bassand, J.-P., Faxon, D. P., Weitz, J. I., Afzal, R., Rush, B., Peters, R. J.G., Natarajan, M. K., Velianou, J. L., Goodhart, D. M., Labinaz, M., Tanguay, J.-F., Fox, K. A.A., Yusuf, S., for the ASPIRE Investigators, (2005). Randomized, Blinded Trial Comparing Fondaparinux With Unfractionated Heparin in Patients Undergoing Contemporary Percutaneous Coronary Intervention: Arixtra Study in Percutaneous Coronary Intervention: A Randomized Evaluation (ASPIRE) Pilot Trial. Circulation 111: 1390-1397 [Abstract] [Full Text]  
• Watts, A. C., Brenkel, I. J. (2005). A postal survey of current thromboprophylactic practices of consultant orthopaedic surgeons in the treatment of fracture of the hip. J Bone Joint Surg Br 87-B: 296-300 [Abstract] [Full Text]  
• Hirsh, J., O'Donnell, M., Weitz, J. I. (2005). New anticoagulants. Blood 105: 453-463 [Abstract] [Full Text]  
• Savi, P., Chong, B. H., Greinacher, A., Gruel, Y., Kelton, J. G., Warkentin, T. E., Eichler, P., Meuleman, D., Petitou, M., Herault, J.-P., Cariou, R., Herbert, J.-M. (2005). Effect of fondaparinux on platelet activation in the presence of heparin-dependent antibodies: a blinded comparative multicenter study with unfractionated heparin. Blood 105: 139-144 [Abstract] [Full Text]  
• Agnelli, G. (2004). Prevention of Venous Thromboembolism in Surgical Patients. Circulation 110: IV-4-IV-12 [Abstract] [Full Text]  
• Turpie, A. G. G., Eriksson, B. I., Bauer, K. A., Lassen, M. R. (2004). Fondaparinux. J Am Acad Orthop Surg 12: 371-375 [Full Text]  
• McGuire, M., Dobesh, P. P. (2004). Therapeutic Update on the Prevention and Treatment of Venous Thromboembolism. Journal of Pharmacy Practice 17: 289-307 [Abstract]  
• Smythe, M. A., Dager, W. E., Patel, N. M. (2004). Managing Complications of Anticoagulant Therapy. Journal of Pharmacy Practice 17: 327-346 [Abstract]  
• Hirsh, J., Raschke, R. (2004). Heparin and Low-Molecular-Weight Heparin: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 126: 188S-203S [Abstract] [Full Text]  
• Weitz, J. I., Hirsh, J., Samama, M. M. (2004). New Anticoagulant Drugs: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 126: 265S-286S [Abstract] [Full Text]  
• Geerts, W. H., Pineo, G. F., Heit, J. A., Bergqvist, D., Lassen, M. R., Colwell, C. W., Ray, J. G. (2004). Prevention of Venous Thromboembolism: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 126: 338S-400S [Abstract] [Full Text]  
• Turpie, A. G.G., Bauer, K. A., Eriksson, B. I., Lassen, M. R. (2004). Superiority of Fondaparinux Over Enoxaparin in Preventing Venous Thromboembolism in Major Orthopedic Surgery Using Different Efficacy End Points. Chest 126: 501-508 [Abstract] [Full Text]  
• Simoons, M. L., Bobbink, I. W. G., Boland, J., Gardien, M., Klootwijk, P., Lensing, A. W. A., Ruzyllo, W., Umans, V. A. W. M., Vahanian, A., Van De Werf, F., Zeymer, U., PENTUA Investigators, (2004). A dose-finding study of fondaparinux in patients with non-ST-segment elevation acute coronary syndromes: The Pentasaccharide in Unstable Angina (PENTUA) study. J Am Coll Cardiol 43: 2183-2190 [Abstract] [Full Text]  
• Dempfle, C.-E. H. (2004). Minor Transplacental Passage of Fondaparinux in Vivo. NEJM 350: 1914-1915 [Full Text]  
• Kuter, D. J. (2004). Thrombotic Complications of Central Venous Catheters in Cancer Patients. The Oncologist 9: 207-216 [Abstract] [Full Text]  
• Kahn, S. R., Ginsberg, J. S. (2004). Relationship Between Deep Venous Thrombosis and the Postthrombotic Syndrome. Arch Intern Med 164: 17-26 [Abstract] [Full Text]  
• Bauer, K. A. (2003). New Pentasaccharides for Prophylaxis of Deep Vein Thrombosis: Pharmacology. Chest 124: 364S-370S [Abstract] [Full Text]  
• Turpie, A. G. G., Eriksson, B. I., Bauer, K. A., Lassen, M. R. (2003). New Pentasaccharides for the Prophylaxis of Venous Thromboembolism: Clinical Studies. Chest 124: 371S-378S [Abstract] [Full Text]  
• Raskob, G. E., Hirsh, J. (2003). Controversies in Timing of the First Dose of Anticoagulant Prophylaxis Against Venous Thromboembolism After Major Orthopedic Surgery. Chest 124: 379S-385S [Abstract] [Full Text]  
• Davidson, B. L., Sullivan, S. D., Kahn, S. R., Borris, L., Bossuyt, P., Raskob, G. (2003). The Economics of Venous Thromboembolism Prophylaxis: A Primer for Clinicians. Chest 124: 393S-396S [Abstract] [Full Text]  
• Tran, A. H, Lee, G. (2003). Fondaparinux for Prevention of Venous Thromboembolism in Major Orthopedic Surgery. The Annals of Pharmacotherapy 37: 1632-1643 [Abstract] [Full Text]  
• Khorana, A. A., Sahni, A., Altland, O. D., Francis, C. W. (2003). Heparin Inhibition of Endothelial Cell Proliferation and Organization Is Dependent on Molecular Weight. Arterioscler. Thromb. Vasc. Bio. 23: 2110-2115 [Abstract] [Full Text]  
• Wiebe, E. M., Stafford, A. R., Fredenburgh, J. C., Weitz, J. I. (2003). Mechanism of Catalysis of Inhibition of Factor IXa by Antithrombin in the Presence of Heparin or Pentasaccharide. J. Biol. Chem. 278: 35767-35774 [Abstract] [Full Text]  
• Eriksson, B. I., Lassen, M. R. (2003). Duration of Prophylaxis Against Venous Thromboembolism With Fondaparinux After Hip Fracture Surgery: A Multicenter, Randomized, Placebo-Controlled, Double-blind Study. Arch Intern Med 163: 1337-1342 [Abstract] [Full Text]  
• Hyers, T. M. (2003). Management of Venous Thromboembolism: Past, Present, and Future. Arch Intern Med 163: 759-768 [Abstract] [Full Text]  
• Deitelzweig, S. B, Vanscoy, G. J, Niccolai, C. S, Rihn, T. L (2003). Venous Thromboembolism Prevention with LMWHs in Medical and Orthopedic Surgery Patients. The Annals of Pharmacotherapy 37: 402-411 [Abstract] [Full Text]  
• Hughes, S. J. (2003). Fondaparinux Requires Further Study Before Firm Recommendation. Arch Intern Med 163: 498-498 [Full Text]  
• Tobu, M., Iqbal, O., Ma, Q., Schultz, C., Jeske, W., Hoppensteadt, D., Lewis, B., Fareed, D., Fareed, J. (2003). Global Anticoagulant Effects of a Synthetic Anti-Factor Xa Inhibitor (DX-9065a): Implications for Interventional Use. CLIN APPL THROMB HEMOST 9: 1-17 [Abstract]  
• Alving, B. M., Francis, C. W., Hiatt, W. R., Jackson, M. R. (2003). Consultations on Patients with Venous or Arterial Diseases. ASH Education Book 2003: 540-558 [Abstract] [Full Text]  
• Bates, S. M., Ginsberg, J. S. (2002). How we manage venous thromboembolism during pregnancy. Blood 100: 3470-3478 [Abstract] [Full Text]  
• Bijsterveld, N. R., Moons, A. H., Boekholdt, S. M., van Aken, B. E., Fennema, H., Peters, R. J.G., Meijers, J. C.M., Buller, H. R., Levi, M. (2002). Ability of Recombinant Factor VIIa to Reverse the Anticoagulant Effect of the Pentasaccharide Fondaparinux in Healthy Volunteers. Circulation 106: 2550-2554 [Abstract] [Full Text]  
• Francis, C. W., Davidson, B. L., Berkowitz, S. D., Lotke, P. A., Ginsberg, J. S., Lieberman, J. R., Webster, A. K., Whipple, J. P., Peters, G. R., Colwell, C. W. Jr. (2002). Ximelagatran versus Warfarin for the Prevention of Venous Thromboembolism after Total Knee Arthroplasty: A Randomized, Double-Blind Trial. ANN INTERN MED 137: 648-655 [Abstract] [Full Text]  
• Heit, J. A. (2002). The Potential Role of Fondaparinux as Venous Thromboembolism Prophylaxis After Total Hip or Knee Replacement or Hip Fracture Surgery. Arch Intern Med 162: 1806-1808 [Full Text]  
• Turpie, A. G. G., Bauer, K. A., Eriksson, B. I., Lassen, M. R., for the Steering Committees of the Pentasaccharide, (2002). Fondaparinux vs Enoxaparin for the Prevention of Venous Thromboembolism in Major Orthopedic Surgery: A Meta-analysis of 4 Randomized Double-blind Studies. Arch Intern Med 162: 1833-1840 [Abstract] [Full Text]  
• Whang, P. G., Lieberman, J. R. (2002). Low-Molecular-Weight Heparin. J Am Acad Orthop Surg 10: 299-302 [Full Text]  
• Hirsh, J., Lee, A. Y. Y. (2002). How we diagnose and treat deep vein thrombosis. Blood 99: 3102-3110 [Abstract] [Full Text]  
• Murashige, N., Kami, M., Marlovits, S., Priestley, M., Scacewater, R., Eriksson, B. I., Diuguid, D. L. (2002). Prevention of Venous Thromboembolism with Fondaparinux. NEJM 346: 940-942 [Full Text]  
• Weitz, J. I., Buller, H. R. (2002). Direct Thrombin Inhibitors in Acute Coronary Syndromes: Present and Future. Circulation 105: 1004-1011 [Full Text]  
• Corti, R., Fuster, V., Badimon, J.J. (2002). Strategy for ensuring a better future for the vessel wall. Eur Heart J Suppl 4: A31-A41 [Abstract]  
• (2001). Fondaparinux Better Than Enoxaparin for VTE Prevention. Journal Watch Cardiology 2001: 3-3 [Full Text]  
• (2001). More Data on a New Antithrombotic Drug. JWatch General 2001: 3-3 [Full Text]  
• Bauer, K. A., Eriksson, B. I., Lassen, M. R., Turpie, A. G.G., the Steering Committee of the Pentasaccharide in M, (2001). Fondaparinux Compared with Enoxaparin for the Prevention of Venous Thromboembolism after Elective Major Knee Surgery. NEJM 345: 1305-1310 [Abstract] [Full Text]  
• Diuguid, D. L. (2001). Choosing a Parenteral Anticoagulant Agent. NEJM 345: 1340-1342 [Full Text]