| Title | Fondaparinux vs enoxaparin for the prevention of venous thromboembolism in major orthopedic surgery: a meta-analysis of 4 randomized double-blind studies. | | Author(s) | Turpie AG, Bauer KA, Eriksson BI, Lassen MR | | Institution | Department of Medicine, Hamilton Health Sciences-General Hospital, 237 Barton, Hamilton, Ontario, Canada L8L 2X2. turpiea@mcmaster.ca | | Source | Arch Intern Med 2002 Sep 9; 162(16):1833-40. | | MeSH | Aged
Anticoagulants
Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Confidence Intervals
Double-Blind Method
Enoxaparin
Female
Fibrinolytic Agents
Fracture Fixation, Internal
Hip Fractures
Humans
Incidence
Male
Middle Aged
Multicenter Studies
Orthopedic Procedures
Polysaccharides
Randomized Controlled Trials
Research Support, Non-U.S. Gov't
Thromboembolism
Time Factors
Treatment Outcome
Venous Thrombosis
| | Abstract | BACKGROUND: Orthopedic surgery remains a condition at high risk of venous thromboembolism (VTE). Fondaparinux, the first of a new class of synthetic selective factor Xa inhibitors, may further reduce this risk compared with currently available thromboprophylactic treatments.
METHODS: A meta-analysis of 4 multicenter, randomized, double-blind trials in patients undergoing elective hip replacement, elective major knee surgery, and surgery for hip fracture (N = 7344) was performed to determine whether a subcutaneous 2.5-mg, once-daily regimen of fondaparinux sodium starting 6 hours after surgery was more effective and as safe as approved enoxaparin regimens in preventing VTE. The primary efficacy outcome was VTE up to day 11, defined as deep vein thrombosis detected by mandatory bilateral venography or documented symptomatic deep vein thrombosis or pulmonary embolism. The primary safety outcome was major bleeding.
RESULTS: Fondaparinux significantly reduced the incidence of VTE by day 11 (182 [6.8%] of 2682 patients) compared with enoxaparin (371 [13.7%] of 2703 patients), with a common odds reduction of 55.2% (95% confidence interval, 45.8% to 63.1%; P<.001); this beneficial effect was consistent across all types of surgery and all subgroups. Although major bleeding occurred more frequently in the fondaparinux-treated group (P =.008), the incidence of clinically relevant bleeding (leading to death or reoperation or occurring in a critical organ) did not differ between groups.
CONCLUSION: In patients undergoing orthopedic surgery, 2.5 mg of fondaparinux sodium once daily, starting 6 hours postoperatively, showed a major benefit over enoxaparin, achieving an overall risk reduction of VTE greater than 50% without increasing the risk of clinically relevant bleeding. | | Language | eng | | Pub Type(s) | Journal Article
Meta-Analysis
| | PubMed ID | 12196081 |
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