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1 June 2004 | Volume 140 Issue 11 | Pages 867-873
Background: The current standard initial therapies for deep venous thrombosis are low-molecular-weight heparin and unfractionated heparin. In a dose-ranging study of patients with symptomatic deep venous thrombosis, fondaparinux had efficacy and a safety profile similar to those of low-molecular-weight heparin (dalteparin).
Objective: To evaluate whether fondaparinux has efficacy and safety similar to those of enoxaparin in patients with deep venous thrombosis.
Design: Randomized, double-blind study.
Setting: 154 centers worldwide.
Patients: 2205 patients with acute symptomatic deep venous thrombosis.
Intervention: Fondaparinux, 7.5 mg (5.0 mg in patients weighing <50 kg and 10.0 mg in patients weighing >100 kg) subcutaneously once daily, or enoxaparin, 1 mg/kg of body weight, subcutaneously twice daily for at least 5 days and until vitamin K antagonists induced an international normalized ratio greater than 2.0.
Measurements: The primary efficacy outcome was the 3-month incidence of symptomatic recurrent venous thromboembolic complications. The main safety outcomes were major bleeding during initial treatment and death. An independent, blinded committee adjudicated all outcomes.
Results: 43 (3.9%) of 1098 patients randomly assigned to fondaparinux had recurrent thromboembolic events compared with 45 (4.1%) of 1107 patients randomly assigned to enoxaparin (absolute difference, –0.15 percentage point [95% CI, –1.8 to 1.5 percentage points]). Major bleeding occurred in 1.1% of patients receiving fondaparinux and 1.2% of patients receiving enoxaparin. Mortality rates were 3.8% and 3.0%, respectively.
Limitations: Follow-up was incomplete in 0.4% of fondaparinux-treated patients and 1.0% of enoxaparin-treated patients.
Conclusions: Once-daily subcutaneous fondaparinux was at least as effective (not inferior) and safe as twice-daily, body weight–adjusted enoxaparin in the initial treatment of patients with symptomatic deep venous thrombosis.
*For a list of the members of The Matisse Investigators, see the Appendix.
Editors' Notes
Context
Contribution
Implications
–The Editors
Author and Article Information
From the Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Swedish Medical Center, University of Washington School of Medicine, Seattle, Washington; Hospital de Bellevue, University Jean Monnet, Saint-Etienne, France; Flinders Medical Centre, Bedford Park, Australia; Hamilton Civic Hospitals Research Centre, Hamilton, Ontario, Canada; Instituto di Clinica Medica, Policlinico San Matteo, University of Pavia, Pavia, Italy; University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma; University Hospital of Maastricht, Maastricht, the Netherlands; Sanofi-Synthélabo, Paris, France; and NV Organon, Oss, the Netherlands.
Grant Support: By Sanofi-Synthélabo and NV Organon.
Potential Financial Conflicts of Interest:Employment: A.E.M. Segers (NV Organon); R. Cariou (Sanofi-Synthélabo); O. Leeuwenkamp (Organon); A.W.A. Lensing (NV Organon). Consultancies: H.R. Büller (Sanofi-Synthélabo, NV Organon); B.L. Davidson (Sanofi-Synthélabo, NV Organon, Bristol-Myers Squibb, Aventis); A. Gallus (Sanofi-Synthélabo, NV Organon); M.H. Prins (Sanofi-Synthélabo, NV Organon); G. Raskob (Sanofi-Synthélabo, NV Organon). Honoraria: H.R. Büller (Sanofi-Synthélabo, NV Organon); B.L. Davidson (Sanofi-Synthélabo, NV Organon); H. Decousus (Sanofi-Synthélabo, NV Organon); A. Gallus (Sanofi-Synthélabo, NV Organon); F. Piovella (Sanofi-Synthélabo, NV Organon); G. Raskob (Sanofi-Synthélabo, NV Organon). Stock ownership or options (other than mutual funds): R. Cariou (Sanofi-Synthélabo). Grants received: H.R. Büller (Sanofi-Synthélabo, NV Organon); H. Decousus (Sanofi-Synthélabo); G. Raskob (Sanofi-Synthélabo, NV Organon). Grants pending: H. Decousus (Sanofi-Synthélabo, NV Organon).
Requests for Single Reprints: Harry R. Büller, MD, Department of Vascular Medicine, Academic Medical Center, F4-211, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
Current Author Addresses: Dr. Büller: Department of Vascular Medicine, Academic Medical Center, F4-211, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
Dr. Davidson: 801 Broadway, Suite 915, Seattle, WA 98122.
Dr. Decousus: Thrombosis Research Group, University Hospital, Hôpital de Bellevue, Pavillon 5, 25 Boulevard Pasteur, 42055 St. Etienne Cedex, France.
Dr. Gallus: Department of Haematology, South Path, Flinders Medical Centre, Level 6, Flinders Drive, Bedford Park, South Australia, 5042 Australia.
Dr. Gent: Henderson Research Center, McMaster University, 711 Concession Street, Hamilton, Ontario L8V 1C3, Canada.
Dr. Piovella: IRCCS Policlinico San Matteo, Via le Golgi 19, 27100 Pavia, Italy.
Dr. Prins: Department of Epidemiology and Medical Technology Assessment, University Hospital of Maastricht, Pieter de Byeplein 1, 6212 HX Maastricht, the Netherlands.
Dr. Raskob: College of Public Health, University of Oklahoma Health Sciences Center, 801 Northeast 13th Street, Room 139, Oklahoma City, OK 73104.
Drs. Segers, Leeuwenkamp, and Lensing: NV Organon, PO Box 20, 5340 BH Oss, the Netherlands.
Dr. Cariou: Therapeutic Thrombosis Department, Sanofi-Synthélabo Recherche, 1 Avenue Pierre Brossolette, Chilly-Mazarin, 91385 Cedex, France.
Author Contributions: Conception and design: H.R. Büller, H. Decousus, A.S. Gallus, M. Gent, F. Piovella, M.H. Prins, G. Raskob, R. Cariou, O. Leeuwenkamp, A.W.A. Lensing.
Analysis and interpretation of the data: H.R. Büller, H. Decousus, A.S. Gallus, M. Gent, F. Piovella, M.H. Prins, G. Raskob, R. Cariou, A.E.M. Segers, O. Leeuwenkamp, A.W.A. Lensing.
Drafting of the article: H.R. Büller, H. Decousus, A.S. Gallus, M. Gent, F. Piovella, M.H. Prins, G. Raskob, R. Cariou, A.E.M. Segers, O. Leeuwenkamp, A.W.A. Lensing.
Critical revision of the article for important intellectual content: H.R. Büller, A.S. Gallus, M. Gent, F. Piovella, M.H. Prins, G. Raskob, R. Cariou, O. Leeuwenkamp, A.W.A. Lensing.
Final approval of the article: H.R. Büller, H. Decousus, A.S. Gallus, M. Gent, F. Piovella, M.H. Prins, G. Raskob, A.E.M. Segers, R. Cariou, O. Leeuwenkamp, A.W.A. Lensing.
Provision of study materials or patients: H.R. Büller, H. Decousus, A.S. Gallus, F. Piovella, M.H. Prins, A.W.A. Lensing.
Statistical expertise: H.R. Büller, M.H. Prins, M. Gent.
Obtaining of funding: H.R. Büller, M.H. Prins.
Administrative, technical, or logistic support: H.R. Büller, M.H. Prins, R. Cariou.
Collection and assembly of data: H.R. Büller, M.H. Prins. ARTICLE
Fondaparinux or Enoxaparin for the Initial Treatment of Symptomatic Deep Venous Thrombosis
A Randomized Trial
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