This study compares safety, efficacy, and cost of the new oral Factor Xa inhibitor rivaroxaban to fondaparinux, an injectable anticoagulant, for prevention of VTE (venous thromboembolism) after hip or knee arthroplasty within an IRF (inpatient rehabilitation facility). In this retrospective review, data was collected on the patients that were either status post total knee arthroplasty or total hip arthroplasty, admitted to the IRF over a 24 month period. All patients identified for inclusion in the study received either fondaparinux subcutaneously or rivaroxaban orally once daily as for VTE prevention. Primary efficacy outcomes were composite of any deep venous thrombosis, non-fatal PE (pulmonary embolism); and all-cause mortality. Primary safety outcomes were any major or non-major bleeding events. Analysis of 314 patient records (199 patients on rivaroxaban and 115 patients on fondaparinux) indicated no PE events. No DVT occurred in the patients prescribed rivaroxaban compared to 0.9% in the fondaparinux group. Major bleeding events occurred in 0.5% of patients prescribed rivaroxaban compared to 1.74% in fondaparinux group. Minor bleeding events occurred in 1% of patients prescribed rivaroxaban compared to 1.74% of patients in fondaparinux group. Direct acquisition cost analysis revealed 52% lower costs than fondaparinux, in the patients treated with rivaroxaban. In this study, rivaroxaban provided a safe and effective alternative to fondaparinux for prevention of VTE in post-operative total hip or knee replacement patients in the IRF setting. Rivaroxaban was also found to be favorable with respect to cost of acquisition, and ease of drug administration.
more units of blood. Minor bleeding events were defined as epistaxis, hemoccult stools, hematuria or hematoma Results or Clinical Course: Analysis of 1766 records demonstrated 1412 patients on warfarin, 218 on fondaparinux, 101 on rivaroxaban and 35 on enoxaparin. Patients treated with warfarin had major bleed incidence 0.85% (n¼12), minor bleed incidence 3.5 % (n¼49) and DVT/PE incidence 2.4% (n¼ 34).Those on fondaparinux had major bleed incidence 0.9% (n¼2), minor bleed incidence 2.3% (n¼ 5) and DVT/PE incidence 0.4% (n¼1). Those on rivaroxaban had no major bleeds, minor bleed incidence of 2% (n¼2) and no DVT/PE. Those on enoxaparin had major bleed incidence 2.8% (n¼1), minor bleed incidence 2.8% (n¼1) and no DVT/PE. Conclusions: Rivaroxaban and enoxaparin were most effective in that there were no incidences of DVT/PE; this was followed by fondaparinux. Warfarin was least effective with greater incidence of DVT/PE. Safety as measured by major bleeds was least in enoxaparin treated group, followed by fondaparinux and warfarin. Rivaroxaban was safest with no major bleeds and it was also favorable due to oral administration and not needing dose monitoring.
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