Rivaroxaban for Thromboprophylaxis After Fracture-Related Orthopedic Surgery in Routine Clinical Practice

Lassen, Michael R.; Haas, Sylvia; Kreutz, Reinhold; Mantovani, LG; Holberg, Gerlind; Turpie, Alexander G. G.

doi:10.1177/1076029615607303

Cited by 19 publications

(14 citation statements)

References 34 publications

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“…There were no cases of fatal or critical bleeding in either treatment group. 17 Similar findings were observed in a small study comparing edoxaban to enoxaparin, but it is underpowered and can report biased conclusions. 18 In a larger retrospective cohort study, rivaroxaban was shown to be more effective than LMWH in the reduction of symptomatic VTE (4.9 vs. 8.6%, p ¼ 0.008) after lower limb fractures, driven by a difference in distal DVTs, without increasing the risk of bleeding.…”

Section: Risk Of Venous Thromboembolism and Available Evidence On Antsupporting

confidence: 59%

Management of Patients Taking Oral Anticoagulants Who Need Urgent Surgery for Hip Fracture

Ostuni

Tiscia

Marongiu

2019

Semin Thromb Hemost

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The number of hip fractures in anticoagulated patients is predicted to increase, due to people living longer. However, evidence regarding urgent perioperative management of elderly patients with hip fracture who take oral anticoagulants (vitamin K antagonists or direct oral anticoagulants) is scarce. In this article, the authors present a narrative review of the evidence to date supporting the urgent management of hip fracture in anticoagulated elderly patients. They discuss the complexity of managing the high risk of procedure-related bleeding and, at the same time, the high risk of thromboembolism. The role of a bridging procedure and the best strategy of anticoagulation reversal are also reviewed. Further studies are required to improve the evidence in urgent surgery, especially in frail elderly patients.

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Section: Risk Of Venous Thromboembolism and Available Evidence On Antsupporting

confidence: 59%

Management of Patients Taking Oral Anticoagulants Who Need Urgent Surgery for Hip Fracture

Ostuni

Tiscia

Marongiu

2019

Semin Thromb Hemost

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“…Regardless of a similar risk factor prevalence in both samples, more cases of thrombosis and bleeding were reported in the enoxaparin group, but the statistical difference was not significant. The higher incidence of thrombotic events in the enoxaparin group was also described in orthopedic studies, suggesting rivaroxaban may be more effective in thromboprophylaxis [ 10 - 11 ]. As opposed to results found in previous research, however, rivaroxaban was not associated with higher bleeding rates [ 4 ].…”

Section: Discussionmentioning

confidence: 85%

“…Rivaroxaban is an oral direct factor Xa inhibitor widely used in the prevention of VTE after major orthopedic surgery. It has been proven to be an effective and safe thromboprophylactic drug when compared to enoxaparin in patients submitted to hip and knee arthroplasty, as well as after below-knee lower-leg fracture surgery [8][9][10][11]. Regarding thromboprophylaxis in medical inpatients, the MAGELLAN trial reported noninferiority of rivaroxaban effectiveness and safety when compared to enoxaparin [4].…”

Section: Introductionmentioning

confidence: 99%

Clinical Outcomes and Costs of Rivaroxaban for Thromboprophylaxis in Acutely Ill Medical Inpatients: A Cross-Sectional Study

Marques

França

Saito

et al. 2021

Cureus

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Introduction: Venous thromboembolism (VTE) is the primary cause of preventable death in hospitalized patients in the United States. This is a cross-sectional study with a brief cost analysis of thromboprophylaxis with rivaroxaban and enoxaparin in acutely ill medical inpatients.Methods: The study included a total of 122 patients admitted to a public teaching hospital from December 2019 to January 2021. The sample was equally divided into two groups according to the thromboprophylactic agent prescribed: rivaroxaban or enoxaparin. The primary outcomes included bleeding and symptomatic, ultrasonography-confirmed arterial or venous thrombotic events during or within 90 days after hospitalization. Our secondary outcome was the direct costs of each anticoagulant in US dollars over the 14 months.Results: During hospitalization, two events were detected in the enoxaparin group: minor bleeding with minimum intervention required (1.6%) and a deep vein thrombosis (DVT) case (1.6%) confirmed by ultrasonography. Within 90 days after discharge, two patients, one of each sample (1.6% vs. 1.6%), were readmitted due to confirmed acute arterial occlusion. Concerning financial assessment, the mean unit cost of enoxaparin during the 14 months assessed was 102.14% more expensive than rivaroxaban.Conclusions: Both rivaroxaban and enoxaparin showed equivalence in effectiveness and safety in thromboprophylaxis in medical inpatients, aside from possible financial benefit with the first-mentioned drug.

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“…A low incidence of wound complications and other adverse events was also observed. Patients with hip/femoral fracture (median age 73 years) who received rivaroxaban had a lower risk of treatment-emergent serious adverse events compared with those receiving SOC (odds ratio 0.26, 95% CI 0.07–0.88), although this effect was less marked in patients with lower-leg fractures (median age 48 years, odds ratio 0.52, 95% CI 0.18–1.47) 49…”

Section: Trauma-related Fracturesmentioning

confidence: 99%

“…Some countries that participated in XAMOS have a wider label that allows the use of rivaroxaban for thromboprophylaxis after lower-limb fracture surgery. An analysis of 790 patients with lower-limb fracture from XAMOS and a XAMOS extension study (XAMOS-Extra) showed that rivaroxaban was associated with a low incidence of symptomatic thromboembolic and bleeding events, either similar to or numerically lower than those seen in patients receiving SOC 49. The overall incidence of symptomatic VTE in the rivaroxaban-treatment group was 0.57%, compared with 1.14% with SOC.…”

Section: Trauma-related Fracturesmentioning

confidence: 99%

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

Beyer‐Westendorf

Mouret

Turpie

2017

ORR

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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.

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Rivaroxaban for Thromboprophylaxis After Fracture-Related Orthopedic Surgery in Routine Clinical Practice

Abstract: These data from routine practice demonstrate that rivaroxaban can provide effective thromboprophylaxis after fracture-related orthopedic surgery of the lower limb with a favorable safety profile.

Cited by 19 publications

References 34 publications

Management of Patients Taking Oral Anticoagulants Who Need Urgent Surgery for Hip Fracture

Management of Patients Taking Oral Anticoagulants Who Need Urgent Surgery for Hip Fracture

Clinical Outcomes and Costs of Rivaroxaban for Thromboprophylaxis in Acutely Ill Medical Inpatients: A Cross-Sectional Study

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

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