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Venous Thromboembolism Prophylaxis in Orthopedic Surgery

Slide: 27 of 30

Summary of Conclusions

The estimated native (i.e., without pharmacological prophylaxis) incidence of DVT after THR and TKR surgery was 39 percent and 46 percent, respectively. Pharmacological prophylaxis decreases the risk of DVT with some increased risk of minor bleeding when compared with no pharmacological prophylaxis. There is some evidence that LMWH decreases risk for DVT when compared with warfarin at the expense of increases in major and minor bleeding. LMWH provides greater protection against DVT and PE when compared with unfractionated heparin while reducing the risk of bleeding and heparin-induced thrombocytopenia. In contrast, LMWH was not as effective in protecting against the risk of DVT when compared with an injectable factor Xa inhibitor, although the odds of bleeding were reduced. Prolonged prophylaxis decreased the risk of thromboembolism at the risk of increased minor bleeding when compared with standard-duration prophylaxis. No differences in mortality outcomes were observed for any of the interventions compared; however, this may be related to the infrequency of this outcome and the length of followup.

After this review was completed, rivaroxaban, an oral factor Xa inhibitor, was approved by the U.S. Food and Drug Administration for this population of patients based primarily on the four Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism (RECORD) trials. Rivaroxaban decreased the risk of the composite primary outcome of DVT, nonfatal PE, or all-cause mortality in patients undergoing major orthopedic surgery. RECORD 1 and 2 showed superiority of prolonged prophylaxis with rivaroxaban versus enoxaparin (prolonged or standard-duration prophylaxis) with a decreased risk of the primary outcome in patients undergoing THR. RECORD 3 and 4 suggested that rivaroxaban decreases the risk of the primary outcome versus enoxaparin when used for prophylaxis for patients undergoing TKR. There were no significant differences in mortality or the risk for bleeding outcomes in all four trials.

Abbreviations: DVT = deep vein thrombosis; LMWH = low-molecular-weight heparin; PE = pulmonary embolism; THR = total hip replacement; TKR = total knee replacement