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Fondaparinux or Enoxaparin for the Initial Treatment of Symptomatic Deep Venous Thrombosis: A Randomized Trial

Harry R. Büller, MD; Bruce L. Davidson, MD; Hervé Decousus, MD; Alexander Gallus, MD; Michael Gent, DSc; Franco Piovella, MD; Martin H. Prins, MD; Gary Raskob, PhD; Annelise E.M. Segers, MD; Roger Cariou, MD; Oscar Leeuwenkamp, PhD; Anthonie W.A. Lensing, MD, The Matisse Investigators*
[+] Article and Author 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.


Ann Intern Med. 2004;140(11):867-873. doi:10.7326/0003-4819-140-11-200406010-00007
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Our study had 3 main goals. First, we wanted to demonstrate whether once-daily subcutaneous fondaparinux as initial therapy for symptomatic, confirmed deep venous thrombosis has efficacy (was not inferior) and safety similar to those of twice-daily subcutaneous enoxaparin, a standard and widely used LMWH regimen. We have demonstrated the noninferiority of fondaparinux. The 3-month rates for recurrence, 3.9% with fondaparinux and 4.1% with enoxaparin, are within previously reported experience with LMWH treatment for deep venous thrombosis, as were the bleeding rates (24). Thrombocytopenia was rare and was not associated with heparin-related antibodies.

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Summary for Patients

Fondaparinux or Enoxaparin for Deep Venous Thrombosis?

The summary below is from the full report titled “Fondaparinux or Enoxaparin for the Initial Treatment of Symptomatic Deep Venous Thrombosis. A Randomized Trial.” It is in the 1 June 2004 issue of Annals of Internal Medicine (volume 140, pages 867-873). The authors are H.R. Büller, B.L. Davidson, H. Decousus, A. Gallus, M. Gent, F. Piovella, M.H. Prins, G. Raskob, A.E.M. Segers, R. Cariou, O. Leeuwenkamp, and A.W.A. Lensing, for The Matisse Investigators.

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