Objective: To systematically review the efficacy and safety of fondaparinux and enoxaparin in the prevention of venous thromboembolism (VTE) after major orthopedic surgery.
Methods: The MEDLINE, EMbase, the Cochrane Library, CNKI, CBM, VIP and Wanfang databases (from their establishment to October, 2012) were searched for randomized controlled trials (RCTs) comparing the effects of fondaparinux and enoxaparin in preventing VTE after major orthopedic surgery. The related journals and conference papers were manually searched. The outcome measurements were the incidence of total VTE, deep venous thrombosis (DVT), symptomatic VTE, pulmonary embolism (PE), major bleeding and any other adverse event. The quality of literatures was evaluated and the data were extracted for meta-analysis.
Results: Five RCTs involving 7611 patients were included pertaining to major knee surgery (1 RCT), hip fracture surgery (2 RCTs) and total hip arthroplasty (3 RCTs). The incidences of total VTE and DVT were significantly lower in fondaparinux group than in enoxaparin group [RR=0.52, 95%CI (0.40,0.67), P<0.00001; RR=0.49, 95%CI (0.42, 0.58), P<0.00001]. The incidence of symptomatic VTE was similar between the two groups [RR=1.52, 95%CI (0.80,2.88), P=0.20]. Fondaparinux was associated with a significantly increased incidence of major bleeding compared to enoxaparin group [RR=1.55, 95%CI (1.14,2.12), P=0.006], but the mortality rates were comparable between the two groups [RR=0.93, 95%CI (0.63,1.37), P=0.72].
Conclusion: Compared with enoxaparin, fondaparinux can reduce the risk of postoperative VTE and do not increase the mortality rate following major orthopedic surgery though with an increased risk of major bleeding.