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Ximelagatran versus Warfarin for the Prevention of Venous Thromboembolism after Total Knee Arthroplasty: A Randomized, Double-Blind Trial

Charles W. Francis, MD; Bruce L. Davidson, MD, MPH; Scott D. Berkowitz, MD; Paul A. Lotke, MD; Jeffrey S. Ginsberg, MD; Jay R. Lieberman, MD; Anne K. Webster, MS; James P. Whipple, MS; Gary R. Peters, MD; and Clifford W. Colwell Jr., MD
[+] Article and Author Information

From University of Rochester School of Medicine and Dentistry, Rochester, New York; University of Washington School of Medicine and Swedish Medical Center, Seattle, Washington; AstraZeneca, Wilmington, Delaware; University of Pennsylvania, Philadelphia, Pennsylvania; McMaster University, Hamilton, Ontario, Canada; University of California, Los Angeles, Los Angeles, California; and Scripps Clinic and Research Foundation, La Jolla, California.


Potential Financial Conflicts of Interest:Employment: S.D. Berkowitz, A.K. Webster, J.P. Whipple, G.R. Peters; Consultancies: C.W. Francis, B.L. Davidson, S.D. Berkowitz, P.A. Lotke, J.S. Ginsberg, J.R. Lieberman; Honoraria: C.W. Francis, B.L. Davidson, S.D. Berkowitz, J.R. Lieberman; Stock ownership: S.D. Berkowitz, A.K. Webster; Grants received: J.S. Ginsberg, C.W. Colwell Jr.

Requests for Single Reprints: Charles W. Francis, MD, Hematology/Oncology Unit, Department of Medicine, University of Rochester Medical Center, Box 610, 601 Elmwood Avenue, Rochester, NY 14642; e-mail, charles_francis@urmc.rochester.edu.

Current Author Addresses: Dr. Francis: Hematology/Oncology Unit, Department of Medicine, University of Rochester Medical Center, Box 610, 601 Elmwood Avenue, Rochester, NY 14642.

Dr. Davidson: University of Washington School of Medicine and Swedish Medical Center, 801 Broadway, Suite 915, Seattle, WA 98122.

Dr. Berkowitz, Ms. Webster, Mr. Whipple, and Dr. Peters: DCC2, 1800 Concord Pike, Wilmington, DE 19850.

Dr. Lotke: University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104.

Dr. Ginsberg: McMaster University Medical Centre, Room 3X28, 1200 Main Street West, Hamilton, Ontario L87 3Z5, Canada.

Dr. Lieberman: UCLA Medical Center, University of California, Los Angeles, 10833 Le Conte Avenue, Los Angeles, CA 90095.

Dr. Colwell: Scripps Clinic, 10666 North Torrey Pines, La Jolla, CA 92037.

Author Contributions: Conception and design: C.W. Francis, B.L. Davidson, P.A. Lotke, J.S. Ginsberg, J.P. Whipple, G.R. Peters, C.W. Colwell Jr.

Analysis and interpretation of the data: C.W. Francis, B.L. Davidson, S.D. Berkowitz, P.A. Lotke, J.S. Ginsberg, J.R. Lieberman, J.P. Whipple, G.R. Peters, C.W. Colwell Jr.

Drafting of the article: C.W. Francis, B.L. Davidson, S.D. Berkowitz, P.A. Lotke, J.S. Ginsberg, G.R. Peters.

Critical revision of the article for important intellectual content: C.W. Francis, B.L. Davidson, S.D. Berkowitz, P.A. Lotke, J.R. Lieberman, G.R. Peters, C.W. Colwell Jr.

Final approval of the article: C.W. Francis, B.L. Davidson, P.A. Lotke, J.S. Ginsberg, J.R. Lieberman, G.R. Peters, C.W. Colwell Jr.

Provision of study materials or patients: B.L. Davidson, P.A. Lotke.

Statistical expertise: B.L. Davidson, J.P. Whipple.

Obtaining of funding: G.R. Peters.

Administrative, technical, or logistic support: B.L. Davidson, A.K. Webster, G.R. Peters.

Collection and assembly of data: B.L. Davidson, S.D. Berkowitz, G.R. Peters.


Ann Intern Med. 2002;137(8):648-655. doi:10.7326/0003-4819-137-8-200210150-00008
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Our findings indicate that ximelagatran, an oral direct thrombin inhibitor, is at least as effective as adjusted-dose warfarin for prophylaxis of DVT after total knee arthroplasty. Symptomatic DVT was infrequent, and incidences were similar in the ximelagatran and warfarin groups (1.7% and 1.8%, respectively). Symptomatic pulmonary embolism occurred in 0.6% and 1.2%, respectively, of these groups. Efficacy was evaluated by venography between days 7 and 12, when most thrombi are present, and also by clinical evaluation between weeks 4 and 8. Any effect on later events cannot be evaluated. Bleeding complications were infrequent and did not differ significantly in the two groups when assessed by objective or subjective measures.

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Figures

Grahic Jump Location
Figure.
Presence (shaded bars) or absence (white bars) of venous thrombosis in patients receiving warfarin, according to international normalized ratio (INR) on postoperative day 3 and day of venography.

Data are means; error bars represent upper bounds of 95% CIs. On day 3, 64 patients had confirmed venous thrombosis and 193 patients did not; on the day of venography, 61 patients had confirmed venous thrombosis and 185 patients did not.

Grahic Jump Location

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Summary for Patients

Ximelagatran versus Warfarin To Prevent Blood Clots after Knee Replacement Surgery

The summary below is from the full report titled “Ximelagatran versus Warfarin for the Prevention of Venous Thromboembolism after Total Knee Arthroplasty. A Randomized, Double-Blind Trial.” It is in the 15 October 2002 issue of Annals of Internal Medicine (volume 137, pages 648-655). The authors are CW Francis, BL Davidson, SD Berkowitz, PA Lotke, JS Ginsberg, JR Lieberman, AK Webster, JP Whipple, GR Peters, and CW Colwell Jr.

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