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 346:975-980 March 28, 2002 Number 13 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Abdominal surgery for cancer carries a high risk of venous thromboembolism, but the optimal duration of postoperative thromboprophylaxis is unknown.

Methods We conducted a double-blind, multicenter trial in which patients undergoing planned curative open surgery for abdominal or pelvic cancer received enoxaparin (40 mg subcutaneously) daily for 6 to 10 days and were then randomly assigned to receive either enoxaparin or placebo for another 21 days. Bilateral venography was performed between days 25 and 31, or sooner if symptoms of venous thromboembolism occurred. The primary end point with respect to efficacy was the incidence of venous thromboembolism between days 25 and 31. The primary safety end point was bleeding during the three-week period after randomization. The patients were followed for three months.

Results The intention-to-treat analysis of efficacy included 332 patients. The rates of venous thromboembolism at the end of the double-blind phase were 12.0 percent in the placebo group and 4.8 percent in the enoxaparin group (P=0.02). This difference persisted at three months (13.8 percent vs. 5.5 percent, P=0.01). Three patients in the enoxaparin group and six in the placebo group died within three months after surgery. There were no significant differences in the rates of bleeding or other complications during the double-blind or follow-up periods.

Conclusions Enoxaparin prophylaxis for four weeks after surgery for abdominal or pelvic cancer is safe and significantly reduces the incidence of venographically demonstrated thrombosis, as compared with enoxaparin prophylaxis for one week.

Source Information

From Academic Hospital, Uppsala, Sweden (D.B.); Università di Perugia, Perugia, Italy (G.A.); Guy's, King's and St. Thomas' School of Medicine, London (A.T.C.); Tel Aviv Sourasky Medical Center, Tel Aviv, Israel (A.E.); Malmö University Hospital, Malmö, Sweden (P.E.N.); and Aventis Pharmaceuticals, Bridgewater, N.J. (A.L.M.-A., F.D.-N.).

Address reprint requests to Dr. Bergqvist at the Department of Surgery, University Hospital, SE-751 85 Uppsala, Sweden, or at david.bergqvist{at}kirurgi.uu.se.

Full Text of this Article

Related Letters:

Prophylaxis against Venous Thromboembolism after Surgery for Cancer
Moulias S., Bouchon J.-P., Meaume S., Bergqvist D., the ENOXACAN II Study Group
Extract | Full Text | PDF  
N Engl J Med 2002; 347:220, Jul 18, 2002. Correspondence

This article has been cited by other articles:

• MICHOTA, F. A. (2009). Prevention of venous thromboembolism after surgery. Cleveland Clinic Journal of Medicine 76: S45-S52 [Abstract] [Full Text]  
• Kucher, N., Spirk, D., Baumgartner, I., Mazzolai, L., Korte, W., Nobel, D., Banyai, M., Bounameaux, H. (2009). Lack of prophylaxis before the onset of acute venous thromboembolism among hospitalized cancer patients: the SWIss Venous ThromboEmbolism Registry (SWIVTER). Ann Oncol 0: mdp406v1-mdp406 [Abstract] [Full Text]  
• Khorana, A. A., Streiff, M. B., Farge, D., Mandala, M., Debourdeau, P., Cajfinger, F., Marty, M., Falanga, A., Lyman, G. H. (2009). Venous Thromboembolism Prophylaxis and Treatment in Cancer: A Consensus Statement of Major Guidelines Panels and Call to Action. JCO 27: 4919-4926 [Abstract] [Full Text]  
• Kakkar, A. K. (2009). Prevention of Venous Thromboembolism in the Cancer Surgical Patient. JCO 27: 4881-4884 [Abstract] [Full Text]  
• Levine, M. N. (2009). New Antithrombotic Drugs: Potential for Use in Oncology. JCO 27: 4912-4918 [Abstract] [Full Text]  
• Patel, A., Anraku, M., Darling, G. E., Shepherd, F. A., Pierre, A. F., Waddell, T. K., Keshavjee, S., de Perrot, M. (2009). Venous thromboembolism in patients receiving multimodality therapy for thoracic malignancies. J. Thorac. Cardiovasc. Surg. 138: 843-848 [Abstract] [Full Text]  
• Pineo, G. F., Hull, R. D. (2009). Economic and Practical Aspects of Thromboprophylaxis With Unfractionated and Low-Molecular-Weight Heparins in Hospitalized Medical Patients. CLIN APPL THROMB HEMOST 15: 489-500 [Abstract]  
• Khorana, A. A. (2009). Cancer and thrombosis: implications of published guidelines for clinical practice. Ann Oncol 20: 1619-1630 [Abstract] [Full Text]  
• Amin, A. N., Lin, J., Yang, G., Stemkowski, S. (2009). Are There Any Differences in the Clinical and Economic Outcomes Between US Cancer Patients Receiving Appropriate or Inappropriate Venous Thromboembolism Prophylaxis?. J Oncol Pract 5: 159-164 [Abstract] [Full Text]  
• Sousou, T., Khorana, A. A. (2009). New Insights Into Cancer-Associated Thrombosis. Arterioscler. Thromb. Vasc. Bio. 29: 316-320 [Abstract] [Full Text]  
• Khorana, A. A., Lyman, G. H. (2009). Incidence and Prevention of Cancer-associated Thrombosis. Am Soc Clin Oncol Ed Book 2009: 321-325 [Abstract] [Full Text]  
• Fotopoulou, C., duBois, A., Karavas, A. N., Trappe, R., Aminossadati, B., Schmalfeldt, B., Pfisterer, J., Sehouli, J. (2008). Incidence of Venous Thromboembolism in Patients With Ovarian Cancer Undergoing Platinum/Paclitaxel-Containing First-Line Chemotherapy: An Exploratory Analysis by the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group. JCO 26: 2683-2689 [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]  
• Spyropoulos, A. C. (2008). Outpatient-Based Primary and Secondary Thromboprophylaxis With Low-Molecular-Weight Heparin. CLIN APPL THROMB HEMOST 14: 63-74 [Abstract]  
• Francis, C. W., Kakkar, A. K., Levine, M. N., Lyman, G. H. (2008). Prevention of Venous Thromboembolism in Patients with Cancer. Am Soc Clin Oncol Ed Book 2008: 250-256 [Abstract] [Full Text]  
• Lyman, G. H., Khorana, A. A., Falanga, A., Clarke-Pearson, D., Flowers, C., Jahanzeb, M., Kakkar, A., Kuderer, N. M., Levine, M. N., Liebman, H., Mendelson, D., Raskob, G., Somerfield, M. R., Thodiyil, P., Trent, D., Francis, C. W. (2007). American Society of Clinical Oncology Guideline: Recommendations for Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer. JCO 25: 5490-5505 [Abstract] [Full Text]  
• Mitchell, S. Y., Lingard, E. A., Kesteven, P., McCaskie, A. W., Gerrand, C. H. (2007). Venous Thromboembolism in Patients with Primary Bone or Soft-Tissue Sarcomas. JBJS 89: 2433-2439 [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]  
• Khorana, A. A. (2007). The NCCN Clinical Practice Guidelines on Venous Thromboembolic Disease: Strategies for Improving VTE Prophylaxis in Hospitalized Cancer Patients. The Oncologist 12: 1361-1370 [Abstract] [Full Text]  
• Simanek, R., Vormittag, R., Hassler, M., Roessler, K., Schwarz, M., Zielinski, C., Pabinger, I., Marosi, C. (2007). Venous thromboembolism and survival in patients with high-grade glioma. Neuro Oncol Duke 9: 89-95 [Abstract] [Full Text]  
• Zurawska, U., Parasuraman, S., Goldhaber, S. Z. (2007). Prevention of Pulmonary Embolism in General Surgery Patients. Circulation 115: e302-e307 [Full Text]  
• Sellier, E., Labarere, J., Bosson, J.-L., Auvray, M., Barrellier, M.-T., Le Hello, C., Belmin, J., Le Roux, P., Sevestre, M.-A., for the Association pour la Promotion de l'Angiolo, (2006). Effectiveness of a guideline for venous thromboembolism prophylaxis in elderly post-acute care patients: a multicenter study with systematic ultrasonographic examination.. Arch Intern Med 166: 2065-2071 [Abstract] [Full Text]  
• Fennerty, A (2006). Venous thromboembolic disease and cancer.. Postgrad. Med. J. 82: 642-648 [Abstract] [Full Text]  
• 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]  
• Stamou, K. M., Toutouzas, K. G., Kekis, P. B., Nakos, S., Gafou, A., Manouras, A., Krespis, E., Katsaragakis, S., Bramis, J. (2006). Prospective Study of the Incidence and Risk Factors of Postsplenectomy Thrombosis of the Portal, Mesenteric, and Splenic Veins. Arch Surg 141: 663-669 [Abstract] [Full Text]  
• (2006). Thromboembolism after pneumonectomy for malignancy: An independent marker of poor outcome.. J. Thorac. Cardiovasc. Surg. 131: 711-718  
• Kroger, K., Weiland, D., Ose, C., Neumann, N., Weiss, S., Hirsch, C., Urbanski, K., Seeber, S., Scheulen, M. E. (2006). Risk factors for venous thromboembolic events in cancer patients. Ann Oncol 17: 297-303 [Abstract] [Full Text]  
• Falanga, A., Zacharski, L. (2005). Deep vein thrombosis in cancer: the scale of the problem and approaches to management. Ann Oncol 16: 696-701 [Abstract] [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]  
• Wittkowsky, A. K. (2004). Anticoagulation in Hypercoagulable Conditions: Special Considerations in the Treatment and Prevention of Venous Thromboembolism. Journal of Pharmacy Practice 17: 308-316 [Abstract]  
• 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]  
• Smetana, G. W., Cohn, S. L., Lawrence, V. A. (2004). Update in Perioperative Medicine. ANN INTERN MED 140: 452-461 [Full Text]  
• Lopez, J. A., Kearon, C., Lee, A. Y.Y. (2004). Deep Venous Thrombosis. ASH Education Book 2004: 439-456 [Abstract] [Full Text]  
• Goldhaber, S. Z., Elliott, C. G. (2003). Acute Pulmonary Embolism: Part II: Risk Stratification, Treatment, and Prevention. Circulation 108: 2834-2838 [Full Text]  
• Bosson, J.-L., Labarere, J., Sevestre, M. A., Belmin, J., Beyssier, L., Elias, A., Franco, A., Le Roux, P. (2003). Deep Vein Thrombosis in Elderly Patients Hospitalized in Subacute Care Facilities: A Multicenter Cross-sectional Study of Risk Factors, Prophylaxis, and Prevalence. Arch Intern Med 163: 2613-2618 [Abstract] [Full Text]  
• Kakkar, A. K., Levine, M., Pinedo, H.M., Wolff, R., Wong, J. (2003). Venous Thrombosis in Cancer Patients: Insights from the FRONTLINE Survey. The Oncologist 8: 381-388 [Abstract] [Full Text]  
• Anderson, F. A. Jr., Spencer, F. A. (2003). Risk Factors for Venous Thromboembolism. Circulation 107: I-9-16 [Abstract] [Full Text]  
• Kearon, C. (2003). Natural History of Venous Thromboembolism. Circulation 107: I-22-30 [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]  
• Murciano, J.-C., Muro, S., Koniaris, L., Christofidou-Solomidou, M., Harshaw, D. W., Albelda, S. M., Granger, D. N., Cines, D. B., Muzykantov, V. R. (2003). ICAM-directed vascular immunotargeting of antithrombotic agents to the endothelial luminal surface. Blood 101: 3977-3984 [Abstract] [Full Text]  
• Moulias, S., Bouchon, J.-P., Meaume, S., Bergqvist, D., the ENOXACAN II Study Group, (2002). Prophylaxis against Venous Thromboembolism after Surgery for Cancer. NEJM 347: 220-220 [Full Text]  
• (2002). Prevention of Venous Thrombosis After Cancer Surgery. JWatch General 2002: 3-3 [Full Text]