Abstract
ObjectiveTo evaluate the efficacy and safety of fondaparinux compared with nadroparin for prevention of venous thromboembolism after arthroplasty. Patients and methodsOne hundred fifteen patients were randomized into 2 treatment groups. Patients were given fondaparinux in Group I and nadroparin in Group II. Measurements were performed on Days 1, 5, and 21. The wound area was assessed with a subjective visual analog scale. ResultsThe blood counts, clinical biochemical tests, and coagulation tests (ie, thrombin time, partial thromboplastin time, activated partial thromboplastin time, fibrinogen, prothrombin time–International Normalized Ratio, and antithrombin III activity) did not show statistically significant differences between Group I and Group II. In both study groups, anti-factor Xa activities increased significantly on the fifth and 21st day. The scores of the subjective visual analog scale showed significance on Day 21. ConclusionsOur results confirm the safety and efficacy of both fondaparinux and nadroparin for prophylaxis after major orthopedic surgery.
Highlights
Venous thromboembolism (VTE), which presents clinically as deep vein thrombosis (DVT) and pulmonary embolism, is the most frequent serious complication after major orthopedic surgery of the lower extremities.[1,2] At present, anticoagulant prophylactic treatments such as low-dose heparin, lowmolecular-weight heparins (LMWHs), warfarin, or recombinant hirudin are recommended, but the frequency of venographically proven DVT still ranges from 16% to 30%.3The development of LMWHs has added a new dimension to the clinical management of thrombotic disorders
Two total hip arthroplasty (THA) and 3 total knee arthoplasty (TKA) patients were excluded from the study due to the postoperative hematoma that was treated with drainage
Two of the TKA patients were excluded from the study due to postoperative wound hematoma that was treated with drainage
Summary
Venous thromboembolism (VTE), which presents clinically as deep vein thrombosis (DVT) and pulmonary embolism, is the most frequent serious complication after major orthopedic surgery of the lower extremities.[1,2] At present, anticoagulant prophylactic treatments such as low-dose heparin, lowmolecular-weight heparins (LMWHs), warfarin, or recombinant hirudin are recommended, but the frequency of venographically proven DVT still ranges from 16% to 30%.3The development of LMWHs has added a new dimension to the clinical management of thrombotic disorders. The growing use of LMWH in the prophylaxis and treatment of acute thrombotic disorders emphasizes the need for characterization of the platelet effects of these anticoagulants.[4]. Fondaparinux (Arixtra; Organon Sanofi-Synthelabo LLC, Oss, the Netherlands) a pentasaccharide, is a selective inhibitor of coagulation factor Xa and interrupts the coagulation cascade by inhibiting thrombin generation without inactivating thrombin. This drug has been shown to be superior to LMWHs in the prevention of DVT after hip or knee replacement, and at least as effective and as safe as LMWHs and unfractionated heparin in patients with pulmonary embolism and DVT.[5,6]
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