Rivaroxaban For Prevention Of Venous Thromboembolism Research Articles

A comparison of aspirin against rivaroxaban for venous thromboembolism prophylaxis after hip or knee arthroplasty: A meta-analysis.

Total knee arthroplasty (TKA) and total hip arthroplasty (THA) patients are at an elevated risk of post-operative venous thromboembolism (VTE). Newer thromboprophylactic agents such as rivaroxaban are increasingly used and effective in preventing thromboembolic events but may worsen bleeding risk. Recent studies have suggested that the more cost-effective aspirin may also be effective in preventing VTE. This systematic review and meta-analysis aimed to compare the efficacy of aspirin against rivaroxaban for the prevention of VTE following TKA and THA. Electronic searches were performed using five databases from their date of inception to August 2018. Relevant studies were identified, with data extracted and meta-analyzed from the studies. Five studies were included, which consisted of 2257 in the aspirin group and 2337 in the rivaroxaban group. There were no differences between aspirin and rivaroxaban for either VTE (p = 0.48) or its components deep vein thrombosis (p = 0.44) and pulmonary embolism (p = 0.98). Also, there were no differences between groups for either major bleeding (p = 0.17), any bleeding (p = 0.62), readmissions (p = 0.37) or wound complications (p = 0.17). Aspirin was not significantly different to rivaroxaban for prevention of VTE or adverse events after TKA or THA. However, this study was limited by the significant heterogeneity of the included studies. More large randomized studies are needed to add to this body of evidence.

Rivaroxaban for prevention and treatment of venous thromboembolism.

Until recently, heparins and vitamin K antagonists (VKAs) were the cornerstones for prevention and treatment of venous thromboembolism (VTE). This situation changed with the introduction of the direct oral anticoagulants, which are now replacing low-molecular-weight heparin for thromboprophylaxis after elective hip or knee arthroplasty and VKAs for VTE treatment. Rivaroxaban, an oral factor Xa inhibitor, was the first direct oral anticoagulant licensed for VTE prevention and treatment. This paper provides the rationale for factor Xa as a target for anticoagulants, describes the development of rivaroxaban, reviews its pharmacological profile, discusses the clinical trials with rivaroxaban for VTE prevention and treatment and highlights areas of uncertainty.

Rivaroxaban for venous thromboembolism prevention after major orthopedic surgery: translating trial data into routine clinical practice.

An established standard of care for the prevention of venous thromboembolism after major orthopedic surgery has been subcutaneous low-molecular-weight heparin. The non-vitamin K antagonist oral anticoagulant rivaroxaban has demonstrated superior efficacy and similar safety to all tested regimens of enoxaparin in large Phase III clinical studies of venous thromboembolism prevention after elective hip and knee arthroplasty. Despite regulatory approval of rivaroxaban for this indication, concerns remain among physicians regarding its optimal and effective use in routine clinical practice. Real-life studies, such as XAMOS and ORTHO-TEP, are providing physicians with more information on the routine use of rivaroxaban for venous thromboembolism prevention after orthopedic surgery, helping to establish its safety and effectiveness in everyday clinical care. Among the most important issues are the risk of bleeding complications, wound healing, timing of first dose, impact of type of anesthesia on thromboprophylaxis effectiveness, patient comorbidities and comedication use, periprocedural management, associated costs, and clinical outcomes in trauma-related fractures. Many of these issues are difficult to study in randomized, double-blind, Phase III trials, and can be assessed more readily using real-life data. In particular, real-life or noninterventional studies lack many of the strict inclusion and exclusion criteria associated with Phase III trials and involve unselected patients who often present with significant comorbidities or comedication use.

New oral anticoagulants: prevention of VTE in phase III studies in total joint replacement surgery and the hospitalized medically-ill patients

Effective venous thromboembolism prophylaxis in hospitalized medically-ill patients and those undergoing orthopaedic surgery remains a challenge for clinicians in the United States. Several new oral anticoagulants, which either directly inhibit the activity of thrombin or factor Xa have been developed and studied for venous thromboembolism (VTE) prevention in phase III trials in these patient populations. These new medications demonstrate several advantages over traditional anticoagulants, including their administration at fixed doses with no requirement for routine coagulation monitoring. Such advantages may potentially be offset by the lack of well-studied methods to reverse their anticoagulant effects and the potential need for standardized testing to monitor their activity in certain situations. This review will provide an overview of the clinical trial results of dabigatran, apixaban and rivaroxaban for VTE prevention in the orthopaedic and medically-ill hospitalized patients.

Complication Rates After Hip or Knee Arthroplasty in Morbidly Obese Patients

Morbid obesity has been shown to be a risk factor for increased complications after THA and TKA; however, large studies that would determine the effect size are lacking. The purposes of this study were to determine whether morbid obesity increased the risk of: (1) venous thromboembolism (VTE), (2) bleeding, (3) other adverse events, and (4) infections during the early postoperative period (up to 6 to 8 weeks) after THA or TKA? Data from the REgulation of Coagulation in ORthopaedic surgery to prevent Deep vein thrombosis and pulmonary embolism (RECORD) clinical trial program of rivaroxaban for prevention of VTE after THA or TKA were analyzed retrospectively. Data for 12,355 patients were reviewed to identify complication rates in morbidly obese patients (BMI≥40 kg/m2) compared with patients with a BMI less than 40 kg/m2. Explorative analyses compared the rates of asymptomatic deep vein thrombosis (DVT), symptomatic DVT, symptomatic pulmonary embolism, bleeding, and other adverse events by BMI group. There were no significant differences in asymptomatic DVT, symptomatic DVT, symptomatic pulmonary embolism, or bleeding, but there were increases in other adverse events (including receipt of blood transfusion, erythema, peripheral edema, diarrhea, gastrointestinal or abdominal pain) and infections (including respiratory tract or lung infections, wound inflammation or infection, and extrasurgical-site infections), in patients with a BMI of 40 kg/m2 or greater compared with patients with a BMI less than 40 kg/m2. After THA or TKA, morbid obesity is not associated with an increased risk of VTE or bleeding but is associated with increased early postoperative complications, including erythema, peripheral edema, diarrhea and gastrointestinal or abdominal pain, wound inflammation or infection, extrasurgical-site infections, and respiratory tract or lung infections. Level III, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Rivaroxaban for venous thromboembolism prevention after total knee arthroplasty: RECORD3 findings

Patients undergoing major orthopaedic surgery are at considerable risk for venous thromboembolism in the days and weeks after surgery. Consequently, thromboprophylaxis after major orthopaedic surgery, including total hip arthroplasty (THA) and total knee arthroplasty (TKA), is regarded as a standard element of the post-surgical care of such patients. A range of agents are available for use as thromboprophylaxis, including low molecular weight heparins, fondaparinux or warfarin. Rivaroxaban—a novel, oral direct Factor Xa inhibitor—was recently assessed as a potential alternative to current prophylactic strategies in phase III clinical trials carried out in the setting of major orthopaedic surgery. Rivaroxaban was compared to enoxaparin both in patients undergoing THA and in patients undergoing TKA. Based on the positive results of these studies, rivaroxaban has recently received marketing approval in the European Union and Canada. Here, we review the clinical database to support the use of this agent after TKA.