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Comparison of ximelagatran with warfarin for the prevention of venous thromboembolism after total knee replacement.
N Engl J Med. 2003 Oct 30; 349(18):1703-12.NEJM

Abstract

BACKGROUND

In a previous study of the prevention of venous thromboembolism after total knee replacement, the efficacy of ximelagatran, an oral direct thrombin inhibitor that does not require monitoring of coagulation or dose adjustment, was found to be similar to that of warfarin at a dose of 24 mg of ximelagatran twice daily. The purpose of the present study was to determine whether a higher dose of ximelagatran is superior to warfarin.

METHODS

This randomized, double-blind trial compared a regimen of 7 to 12 days of oral ximelagatran, at a dose of 24 or 36 mg twice daily, starting the morning after surgery, with warfarin therapy started the evening of the day of surgery. The composite end point of venous thromboembolism and death from all causes and the incidence of bleeding were the primary outcome measures.

RESULTS

Among the 1851 patients in the efficacy analysis, oral ximelagatran at a dose of 36 mg twice daily was superior to warfarin with respect to the primary composite end point of venous thromboembolism and death from all causes (20.3 percent vs. 27.6 percent; P=0.003). There were no significant differences between these two groups with respect to major bleeding (incidence, 0.8 percent and 0.7 percent, respectively), perioperative indicators of bleeding, wound characteristics, or the composite secondary end point of proximal deep-vein thrombosis, pulmonary embolism, and death (2.7 percent vs. 4.1 percent; P=0.17).

CONCLUSIONS

The efficacy of oral ximelagatran, administered starting the morning after total knee replacement, was superior to that of warfarin for prevention of venous thromboembolism. Rates of hemorrhagic complications with the two drugs were similar.

Authors+Show Affiliations

Department of Medicine, University of Rochester, Rochester, NY, USA. charles_francis@urmc.rochester.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14585938

Citation

Francis, Charles W., et al. "Comparison of Ximelagatran With Warfarin for the Prevention of Venous Thromboembolism After Total Knee Replacement." The New England Journal of Medicine, vol. 349, no. 18, 2003, pp. 1703-12.
Francis CW, Berkowitz SD, Comp PC, et al. Comparison of ximelagatran with warfarin for the prevention of venous thromboembolism after total knee replacement. N Engl J Med. 2003;349(18):1703-12.
Francis, C. W., Berkowitz, S. D., Comp, P. C., Lieberman, J. R., Ginsberg, J. S., Paiement, G., Peters, G. R., Roth, A. W., McElhattan, J., & Colwell, C. W. (2003). Comparison of ximelagatran with warfarin for the prevention of venous thromboembolism after total knee replacement. The New England Journal of Medicine, 349(18), 1703-12.
Francis CW, et al. Comparison of Ximelagatran With Warfarin for the Prevention of Venous Thromboembolism After Total Knee Replacement. N Engl J Med. 2003 Oct 30;349(18):1703-12. PubMed PMID: 14585938.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of ximelagatran with warfarin for the prevention of venous thromboembolism after total knee replacement. AU - Francis,Charles W, AU - Berkowitz,Scott D, AU - Comp,Philip C, AU - Lieberman,Jay R, AU - Ginsberg,Jeffrey S, AU - Paiement,Guy, AU - Peters,Gary R, AU - Roth,Anne W, AU - McElhattan,Jennifer, AU - Colwell,Clifford W,Jr AU - ,, PY - 2003/10/31/pubmed PY - 2003/11/6/medline PY - 2003/10/31/entrez SP - 1703 EP - 12 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 349 IS - 18 N2 - BACKGROUND: In a previous study of the prevention of venous thromboembolism after total knee replacement, the efficacy of ximelagatran, an oral direct thrombin inhibitor that does not require monitoring of coagulation or dose adjustment, was found to be similar to that of warfarin at a dose of 24 mg of ximelagatran twice daily. The purpose of the present study was to determine whether a higher dose of ximelagatran is superior to warfarin. METHODS: This randomized, double-blind trial compared a regimen of 7 to 12 days of oral ximelagatran, at a dose of 24 or 36 mg twice daily, starting the morning after surgery, with warfarin therapy started the evening of the day of surgery. The composite end point of venous thromboembolism and death from all causes and the incidence of bleeding were the primary outcome measures. RESULTS: Among the 1851 patients in the efficacy analysis, oral ximelagatran at a dose of 36 mg twice daily was superior to warfarin with respect to the primary composite end point of venous thromboembolism and death from all causes (20.3 percent vs. 27.6 percent; P=0.003). There were no significant differences between these two groups with respect to major bleeding (incidence, 0.8 percent and 0.7 percent, respectively), perioperative indicators of bleeding, wound characteristics, or the composite secondary end point of proximal deep-vein thrombosis, pulmonary embolism, and death (2.7 percent vs. 4.1 percent; P=0.17). CONCLUSIONS: The efficacy of oral ximelagatran, administered starting the morning after total knee replacement, was superior to that of warfarin for prevention of venous thromboembolism. Rates of hemorrhagic complications with the two drugs were similar. SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/14585938/Comparison_of_ximelagatran_with_warfarin_for_the_prevention_of_venous_thromboembolism_after_total_knee_replacement_ L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa035162?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -