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Extended Venous Thromboembolism Prophylaxis After Total Hip Replacement
A Comparison of Low-Molecular-Weight Heparin With Oral Anticoagulant
Charles Marc Samama, MD, PhD;
Muriel Vray, PhD;
Jeanne Barré, MD;
Jean-Noël Fiessinger, MD;
Nadia Rosencher, MD;
Thomas Lecompte, MD;
Gérard Potron, MD;
Joseph Basile, MD;
Russell Hull, MBBS, MSc;
Denise Desmichels, PhD;
for the SACRE Study Investigators
Arch Intern Med. 2002;162:2191-2196.
Background Oral anticoagulants and low-molecular-weight heparin are both recommended for venous thromboembolism prophylaxis after total hip replacement. To date, these regimens have not been compared by means of clinical end points in the extended prophylaxis setting.
Methods We randomly assigned 1279 patients 3 days after total hip replacement surgery to fixed-dose subcutaneous low-molecular-weight heparin (reviparin sodium, 4200 anti-Xa IU) or adjusted-dose oral anticoagulant (international normalized ratio, 2-3; acenocoumarol) for a 6-week period. The primary end point was the failure rate, defined as the combined clinical events of a confirmed symptomatic thromboembolic event, a major hemorrhage, or death. All patients were followed up throughout the study interval. The primary objective was to compare the observed cumulative failure rate in the low-molecular-weight heparin vs oral anticoagulant group.
Results In the intent-to-treat population, objectively documented symptomatic thromboembolic events occurred in 15 (2.3%) of 643 patients vs 21 (3.3%) of 636 patients receiving low-molecular-weight heparin or oral anticoagulants, respectively (P = .30; 95% confidence interval for the difference, -0.8% to 2.8%). Major bleeding occurred in 9 (1.4%) of 643 patients vs 35 (5.5%) of 636 patients receiving low-molecular-weight heparin or oral anticoagulants, respectively (P = .001). The failure rate was 24 (3.7%) of 643 patients compared with 53 (8.3%) of 636 patients who received low-molecular-weight heparin or oral anticoagulants (P = .001).
Conclusions A significantly higher benefit-risk ratio was observed for patients undergoing elective hip replacement who received extended out-of-hospital prophylaxis with low-molecular-weight heparin vs acenocoumarol. Low-molecular-weight heparin prophylaxis was at least as effective as oral anticoagulants, but with a marked improvement in safety.
From the Département d'Anesthésie-Réanimation, Centre Hospitalier Universitaire Avicenne, Assistance Publique-Hopitaux de Paris, Université Paris 13, Bobigny, France (Dr Samama); Institut National de la Santé et de la Recherche Médicale SC4, Service des Maladies Infectieuses, Hopital Paul Brousse, Villejuif, France (Dr Vray); Département d'Anesthésie-Réanimation, Centre Hospitalier Universitaire Robert Debré, Reims, France (Dr Barré); Service de Médecine Vasculaire, Hopital Européen Georges Pompidou, Paris, France (Dr Fiessinger); Département d'Anesthésie-Réanimation, Centre Hospitalier Universitaire Cochin, Paris (Dr Rosencher); Laboratoire d'Hématologie, Centre Hospitalier Universitaire Régional de Nancy, Nancy, France (Dr Lecompte); Laboratoire d'Hématologie, Centre Hospitalier Universitaire Robert Debré, Reims (Dr Potron); Polyclinique Chirurgicale, Saint Georges de Didonne, France (Dr Basile); Thrombosis Research Unit, University of Calgary, Alberta (Dr Hull); and Knoll-France, Levallois-Perret, France (Dr Desmichels).
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