A 12 month review of a modified protocol using low dose Dabigatran Etexilate in postoperative thromboembolic prophylaxis in joint replacement surgery

Padmanabhan, S.; Kantharuban, Shanjitha; Shilston, Sophie; Pearce, Oliver

doi:10.1186/1477-9560-10-14

Cited by 5 publications

(5 citation statements)

References 15 publications

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“… 26 Two other studies evaluated the outcomes of a VTE protocol when switching from LMWH to dabigatran, which showed promising results. 27 , 28 However, all these studies had insufficient number of patients to extrapolate their findings to the general population, as opposed to this study, given the size of our patient sample.…”

Section: Discussionmentioning

confidence: 91%

Incidence of symptomatic venous thromboembolism in 2372 knee and hip replacement patients after discharge: data from a thromboprophylaxis registry in Montreal, Canada

Senay

Trottier

Delisle

et al. 2018

VHRM

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BackgroundLow-molecular-weight heparin (LMWH) is a recommended anticoagulant for thromboprophylaxis after major orthopedic surgery. Dabigatran etexilate is an oral anticoagulant recognized as noninferior to LMWH. We aimed to assess the incidence of symptomatic venous thromboembolic events (VTEs) after discharge in patients who underwent joint replacement, using a hospital registry.Patients and methodsPatients who underwent total knee and hip arthroplasty between September 2011 and March 2015 were selected. Subcutaneous enoxaparin (30 mg twice daily) was given during hospitalization. At discharge, patients received either enoxaparin 30 mg twice daily/40 mg once daily or dabigatran 220 mg/150 mg once daily. Patients were seen or called at 2, 6, and 12 weeks after surgery. Outcomes were the number of VTEs, including deep venous thrombosis, pulmonary embolism, and the number of major/minor bleeding events after discharge.ResultsAfter discharge, 1468 patients were prescribed enoxaparin and 904 dabigatran (1396 total knee arthroplasty and 976 total hip arthroplasty patients). Mean age was 66±10 years, and 60% were female. The cumulative incidence of VTEs during the 12-week follow-up was 0.7%. One patient sustained a VTE during the switch window. Seven patients sustained a pulmonary embolism (0.3%). There was no statistical difference between the total knee arthroplasty and total hip arthroplasty groups. The incidence of major and minor bleeding events during follow-up was 0.3% and 30.3%, respectively. These events had a higher incidence in the dabigatran group compared to the enoxaparin group after discharge (p<0.05), but not between knee and hip replacement groups for major bleeding events.ConclusionA pharmaceutical prophylaxis protocol using LMWH and dabigatran during the post-discharge period resulted in low incidences of VTE and equivalence between treatments. However, the increased number of major and minor bleeding events in patients taking dabigatran is of concern regarding the safety and needs to be evaluated using analyses adjusted for risk factors.

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Section: Discussionmentioning

confidence: 91%

Incidence of symptomatic venous thromboembolism in 2372 knee and hip replacement patients after discharge: data from a thromboprophylaxis registry in Montreal, Canada

Senay

Trottier

Delisle

et al. 2018

VHRM

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“…Of note, these disadvantages would not be related to dabigatran specifically, but to the group of NOACs in general. Preliminary data evaluating post-procedural dalteparin administration followed by outpatient use of dabigatran showed that this could be an effective and well-tolerated approach in patients undergoing THR/TKR surgery (38).…”

Section: Evidence From Real-life Studies With Noacsmentioning

confidence: 99%

Benefit–risk profile of non-vitamin K antagonist oral anticoagulants in the management of venous thromboembolism

Beyer‐Westendorf

Ageno²

2015

Thromb Haemost

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SummaryThe prevention and treatment of venous thromboembolism (VTE) remains a clinical challenge, primarily owing to drawbacks associated with the use of heparins and vitamin K antagonists (VKAs). These and other factors, including a growing elderly population, mean that VTE presents a continuing burden to patients and physicians. Anticoagulant therapy is a fundamental approach for VTE management. Non-VKA oral anticoagulants, including the factor Xa inhibitors apixaban, edoxaban and rivaroxaban, and the thrombin inhibitor dabigatran, have been studied in phase III trials across a spectrum of thromboembolic disorders. These agents offer simplified care, with similar or improved efficacy and safety outcomes compared with heparins and vitamin K antagonists. There are several factors a physician must consider when prescribing an anticoagulant. An important consideration with all anticoagulant use is bleeding risk, especially in high-risk groups such as the elderly or those with renal impairment or cancer. In orthopaedic patients, other risks include a need for surgical revision or blood transfusion, or wound complications. Therefore, the clinical benefits of an anticoagulant should ideally be balanced with any risks associated with the therapy. Quantitative benefit-risk assessments are lacking, and owing to differences in trial design the non-VKA oral anticoagulants cannot be compared directly. Based on trial and "reallife" data, this review will summarise the clinical data for the non-VKA oral anticoagulants in the prevention and treatment of VTE, focusing on the balance between the benefits and risks of anticoagulation with these drugs, and their potential impact on VTE management.

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“…Studies that evaluated dabigatran utility in the real-world setting showed that dabigatran was an effective anticoagulant with an acceptable safety profile, but did not report comparative outcomes with SOC. 18 – 20 Apixaban has been associated with a trend towards a lower risk of bleeding versus enoxaparin in clinical studies, 21 – 24 but this has not yet been confirmed in routine practice.…”

Section: Discussionmentioning

confidence: 99%

Real-world data confirm clinical trial outcomes for rivaroxaban in orthopaedic patients

Kwong

Turpie

2015

Current Orthopaedic Practice

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Venous thromboembolism (VTE) is a potential cause of morbidity and mortality in patients after major orthopaedic surgery. Based on the results of the international phase III RECORD (Regulation of Coagulation in Orthopaedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism) program, the oral, direct Factor Xa inhibitor rivaroxaban has been approved in many countries for the prevention of VTE after elective hip arthroplasty or knee arthroplasty. However, study results of randomized controlled trials may have limited generalizability to routine clinical practice in unselected patients. The phase IV XAMOS (Xarelto® in the Prophylaxis of Postsurgical Venous Throboembolism after Elective Major Orthopaedic Surgery of the Hip or Knee) study and the ORTHO-TEP (large single-center registry) collected real-world data to assess the effectiveness and safety of rivaroxaban compared with standard of care in large cohorts of patients undergoing major orthopaedic surgery. This review evaluates real-world data from XAMOS and ORTHO-TEP, confirming the favorable benefit–risk profile of rivaroxaban for the prevention of VTE in patients after major orthopaedic surgery that was demonstrated by the phase III RECORD studies in patients after elective hip or knee arthroplasty.

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A 12 month review of a modified protocol using low dose Dabigatran Etexilate in postoperative thromboembolic prophylaxis in joint replacement surgery

Cited by 5 publications

References 15 publications

Incidence of symptomatic venous thromboembolism in 2372 knee and hip replacement patients after discharge: data from a thromboprophylaxis registry in Montreal, Canada

Incidence of symptomatic venous thromboembolism in 2372 knee and hip replacement patients after discharge: data from a thromboprophylaxis registry in Montreal, Canada

Benefit–risk profile of non-vitamin K antagonist oral anticoagulants in the management of venous thromboembolism

Real-world data confirm clinical trial outcomes for rivaroxaban in orthopaedic patients

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