Article

The Efficacy and Safety of Rivaroxaban for Venous Thromboembolism Prophylaxis after Total Hip and Total Knee Arthroplasty

Department of Orthopaedic Surgery, University of Texas Southwestern Medical Center, 1801 Inwood Road, Dallas, TX 75390-8883, USA.
Thrombosis 02/2013; 2013:762310. DOI: 10.1155/2013/762310
Source: PubMed

ABSTRACT Venous thromboembolism (VTE) is a common complication after total hip and total knee arthroplasty. Currently used methods of VTE prophylaxis after these procedures have important limitations, including parenteral administration, and unpredictable plasma levels requiring frequent monitoring and dose adjustment leading to decreased patient compliance with recommended guidelines. New oral anticoagulants have been demonstrated in clinical trials to be equally efficacious to enoxaparin and allow for fixed dosing without the need for monitoring. Rivaroxaban is one of the new oral anticoagulants and is a direct factor Xa inhibitor that has demonstrated superior efficacy to that of enoxaparin. However, the data also suggest that rivaroxaban has an increased risk of bleeding compared to enoxaparin. This paper reviews the available data on the efficacy and safety of rivaroxaban for VTE prophylaxis after total hip and total knee arthroplasty.

0 Bookmarks
 · 
64 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: There have been no comprehensive studies that have compared the incidence of symptomatic VTE over a spectrum of different urgent or elective surgical procedures. In this study we determined the incidence of symptomatic venous thromboembolic events (VTE) within a 3 month period after 76 different surgical procedures. Using a large administrative data-base, we analyzed 1,653,275 cases that underwent one of 76 selected surgical procedures between January 1, 1992 and September 30, 1996. The principal outcomes were venous thrombosis or pulmonary embolism, during either the initial hospitalization or a re-hospitalization for VTE within 91 days of the date of surgery. Predictors of VTE were analyzed using logistic regression. Overall, VTE was diagnosed in 13,533 cases (0.8%, 95% CI = 0.7-0.9%) and of these, 5049 (37%, 95% CI = 36-38%) had pulmonary embolism. Predictors of VTE included: advancing age (OR=1.1 per 5 year increment in age, 95% CI =1.1-1.1), Latino ethnicity (OR = 0.9, 95% CI = 0.8-0.9), Asian/Pacific Islander ethnicity (OR = 0.5, 95% CI = 0.4-0.6), presence of a malignancy (OR = 1.7, 95% CI = 1.6-1.8) and prior VTE (OR = 6.2, 95% CI = 5.5-7.0). High-risk procedures that had an incidence of symptomatic VTE of approximately 2 to 3% included invasive neurosurgery, total hip arthroplasty, major vascular surgery and radical cystectomy. Fifty-six percent of all VTE events diagnosed within 91 days of surgery occurred after discharge. The findings of this study provide a basis for categorizing different surgical procedures as low, intermediate, high and very high risk for VTE. Because of the high incidence of VTE diagnosed after hospital discharge, further studies of extended thromboprophylaxis appear warranted.
    Thrombosis and Haemostasis 10/2003; 90(3):446-55. · 5.76 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Over a 13-year period we studied all patients who underwent major hip and knee surgery and were diagnosed with objectively confirmed symptomatic venous thromboembolism, either deep venous thrombosis or non-fatal pulmonary embolism, within six months after surgery. Low-molecular-weight heparin had been given while the patients were in hospital. There were 5607 patients. The cumulative incidence of symptomatic venous thromboembolism was 2.7% (150 of 5607), of which 1.1% had developed pulmonary embolism, 1.5% had deep venous thrombosis and 0.6% had both. Patients presented with deep venous thrombosis at a median of 24 days and pulmonary embolism at 17 days after surgery for hip fracture. After total hip replacement, deep venous thrombosis and pulmonary embolism occurred at a median of 21 and 34 days respectively. After total knee replacement, the median time to the presentation of deep venous thrombosis and pulmonary embolism was 20 and 12 days respectively. The cumulative risk of venous thromboembolism lasted for up to three months after hip surgery and for one month after total knee replacement. Venous thromboembolism was diagnosed after discharge from hospital in 70% of patients who developed this complication. Despite hospital-based thromboprophylaxis, most cases of clinical venous thromboembolism occur after discharge and at different times according to the operation performed.
    The Bone & Joint Journal 04/2006; 88(3):386-91. · 2.80 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The optimal strategy for thromboprophylaxis after major joint replacement has not been established. Low-molecular-weight heparins such as enoxaparin predominantly target factor Xa but to some extent also inhibit thrombin. Apixaban, a specific factor Xa inhibitor, may provide effective thromboprophylaxis with a low risk of bleeding and improved ease of use. In a double-blind, double-dummy study, we randomly assigned patients undergoing total knee replacement to receive 2.5 mg of apixaban orally twice daily or 30 mg of enoxaparin subcutaneously every 12 hours. Both medications were started 12 to 24 hours after surgery and continued for 10 to 14 days. Bilateral venography was then performed. The primary efficacy outcome was a composite of asymptomatic and symptomatic deep-vein thrombosis, nonfatal pulmonary embolism, and death from any cause during treatment. Patients were followed for 60 days after anticoagulation therapy was stopped. A total of 3195 patients underwent randomization, with 1599 assigned to the apixaban group and 1596 to the enoxaparin group; 908 subjects were not eligible for the efficacy analysis. The overall rate of primary events was much lower than anticipated. The rate of the primary efficacy outcome was 9.0% with apixaban as compared with 8.8% with enoxaparin (relative risk, 1.02; 95% confidence interval, 0.78 to 1.32). The composite incidence of major bleeding and clinically relevant nonmajor bleeding was 2.9% with apixaban and 4.3% with enoxaparin (P=0.03). As compared with enoxaparin for efficacy of thromboprophylaxis after knee replacement, apixaban did not meet the prespecified statistical criteria for noninferiority, but its use was associated with lower rates of clinically relevant bleeding and it had a similar adverse-event profile. (ClinicalTrials.gov number, NCT00371683.)
    New England Journal of Medicine 09/2009; 361(6):594-604. · 54.42 Impact Factor

Full-text (2 Sources)

Download
15 Downloads
Available from
May 27, 2014