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Prevention of Venous Thromboembolism after Knee Arthroplasty: A Randomized, Double-Blind Trial Comparing Enoxaparin with Warfarin

Jacques R. Leclerc, MD; William H. Geerts, MD; Louis Desjardins, MD; George H. Laflamme, MD; Bernard l'Esperance, MD; Christine Demers, MD; Jeannine Kassis, MD; Moira Cruickshank, MD, MSc; Lucinda Whitman, MD; and Fernand Delorme, MD
[+] Article, Author, and Disclosure Information

From McGill University and Universite de Montreal, Montreal, Quebec, Canada; University of Toronto, Toronto, Ontario, Canada; Universite Laval, Ste. Foy, Quebec, Canada; and the University of Western Ontario, London, Ontario, Canada. Acknowledgments: The authors thank 1) Dr. Francois Jobin [Hopital du St-Sacrement], who contributed to the study design; 2) the surgeons who referred the patients: Drs. C.E. Brooks, E. Lenczner, D. Burke, and M. Tanzer (The Montreal General Hospital); Drs. J. Schatzker, M. Tile, and G. Hunter (Sunny-brook Health Science Centre); Drs. J.F. Fradet, P. Kinnard, F. Morin, R. Grenier, and R. Lirette (Centre Hospitalier de l'Universite Laval); Drs. G.H. Laflamme, P. Beaumont, and P. Ranger (Hopital du Sacre-Coeur); Drs. J.M. Levesque, G. Brochu, R. Cloutier, A. Normand, and J. Simard (Hopital du St-Sacrement); Drs. M. Fallaha and R. Antoun (Hopital Maisonneuve-Rosemont); Drs. R. Bourne and C. Rorabeck (University Hospital); and Drs. P. Rockwood, C. Lendells, N. Turner, F. Noftall, D. Squire, and D. Peddle [Memorial]; 3) the unblinded oral medication monitors: Dr. I. Webb (The Montreal General Hospital); Dr. R. Jay (Sunnybrook Health Science Center); Drs. M. Ruel, L. Couture, and J. Villeneuve (Centre Hospitalier de l'Universite Laval); Dr. M. Laurier (Hopital du Sacre-Coeur); Drs. C. Doyle and A. Blais (Hopital du St-Sacrement); Dr. R. Lavallee (Hopital Maisonneuve-Rosemont); Dr. R.K. Stuart (University Hospital); Drs. C. Richardson, G. Adams, and K. Grewal [Memorial]; 4) the research nurses: B. St-Jacques, S. Finkenbine, and L. Porco (The Montreal General Hospital); K. Code (Sunnybrook Health Science Center); L. St-Pierre and J. Cote (Centre Hospitalier de l'Universite Laval); N. Tasse and S. Carrignan (Hopital du Sacre-Coeur); J. Poulin and L. Dube (Hopital du St-Sacrement); S. Bornais (Hopital Maisonneuve-Rosemont); M. Lewinski (University Hospital); C. Bishop [Memorial]; 5) the Steering Committee: Dr. A.G.G. Turpie [chair] and Drs. S. Yusuf and J. Sadler; and 6) the Safety Committee: Dr. L. Joseph (chair) and Drs. M. David, G.P. Blake, and G. Paiement. Grant Support: By a research grant from Rhone-Poulenc Rorer Canada. Requests for Reprints: Jacques R. Leclerc, MD, Cardiovascular Research, Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285. Current Author Addresses: Dr. Leclerc: Cardiovascular Research, Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285.

Copyright ©2004 by the American College of Physicians

Ann Intern Med. 1996;124(7):619-626. doi:10.7326/0003-4819-124-7-199604010-00001
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Objective: To compare the effectiveness and safety of fixed-dose enoxaparin and adjusted-dose warfarin in preventing venous thromboembolism after knee arthroplasty.

Design: A randomized, double-blind controlled trial.

Setting: 8 university hospitals.

Patients: 670 consecutive patients who had knee arthroplasty.

Intervention: Patients were randomly assigned to receive enoxaparin (30 mg subcutaneously every 12 hours) or adjusted-dose warfarin (international normalized ratio, 2.0 to 3.0). Both regimens were started after surgery.

Measurements: The primary end point was the incidence of deep venous thrombosis in patients with adequate bilateral venograms; the secondary end point was hemorrhage.

Results: Among the 417 patients with adequate venograms, 109 of 211 warfarin recipients (51.7%) had deep venous thrombosis compared with 76 of 206 enoxaparin recipients (36.9%) (P = 0.003). The absolute risk difference was 14.8% in favor of enoxaparin (95% CI, 5.3% to 24.1%). Twenty-two warfarin recipients (10.4%) and 24 enoxaparin recipients (11.7%) had proximal venous thrombosis (P > 0.2). The absolute risk difference was 1.2% in favor of warfarin (CI, −7.2% to 4.8%). The incidence of major bleeding was 1.8% (6 of 334 patients) in the warfarin group and 2.1% (7 of 336 patients) in the enoxaparin group (P > 0.2). The absolute risk difference was 0.3% in favor of warfarin (CI, −2.4% to 1.8%).

Conclusions: A postoperative, fixed-dose enoxaparin regimen is more effective than adjusted-dose warfarin in preventing total deep venous thrombosis after knee arthroplasty. No differences were seen in the incidence of proximal venous thrombosis or clinically overt hemorrhage.





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