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1 April 1996 | Volume 124 Issue 7 | Pages 619-626
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.
Author and Article 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.
ARTICLE
Prevention of Venous Thromboembolism after Knee Arthroplasty
A Randomized, Double-Blind Trial Comparing Enoxaparin with Warfarin
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.
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