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      Oral Thromboprophylaxis Following Total Hip or Knee Replacement: Review and Multicentre Experience with Dabigatran Etexilate

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          Abstract

          The risk of venous thromboembolism (VTE) in patients undergoing total knee or hip replacement surgery is high. As a result, thromboprophylaxis is highly recommended. While current thromboprophylactic agents, such as low molecular weight heparins (LMWH) and vitamin K antagonists, are safe and effective their use can be problematic. Therefore, there is a need for alternative anticoagulants that are as safe and effective as conventional agents, but are more convenient and easier to use. Dabigatran etexilate, a direct thrombin inhibitor, is one such anticoagulant. For VTE prevention following major orthopaedic surgery, dabigatran etexilate shows similar efficacy and safety to the LMWH enoxaparin, and is approved for use in more than 75 countries, including Europe and Canada. Here, we summarize and discuss the experiences of four German clinics that have recently introduced dabigatran etexilate into clinical practice. Overall, dabigatran etexilate was well received by patients, surgeons and nurses, and compared favourably with enoxaparin. Staff appreciated the oral, single-dose administration of dabigatran etexilate. Patient satisfaction was high, especially in those individuals who had previously used LMWHs. In this review, we also address a number of questions that were asked by patients or staff; this will be of relevance to orthopaedic surgeons and nurses. We conclude that, in these four German clinics, dabigatran etexilate offered an effective oral alternative to existing thromboprophylactic agents in patients undergoing major orthopaedic surgery.

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          Most cited references26

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          Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition).

          This article discusses the prevention of venous thromboembolism (VTE) and is part of the Antithrombotic and Thrombolytic Therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Grade 1 recommendations are strong and indicate that the benefits do or do not outweigh risks, burden, and costs. Grade 2 suggestions imply that individual patient values may lead to different choices (for a full discussion of the grading, see the "Grades of Recommendation" chapter by Guyatt et al). Among the key recommendations in this chapter are the following: we recommend that every hospital develop a formal strategy that addresses the prevention of VTE (Grade 1A). We recommend against the use of aspirin alone as thromboprophylaxis for any patient group (Grade 1A), and we recommend that mechanical methods of thromboprophylaxis be used primarily for patients at high bleeding risk (Grade 1A) or possibly as an adjunct to anticoagulant thromboprophylaxis (Grade 2A). For patients undergoing major general surgery, we recommend thromboprophylaxis with a low-molecular-weight heparin (LMWH), low-dose unfractionated heparin (LDUH), or fondaparinux (each Grade 1A). We recommend routine thromboprophylaxis for all patients undergoing major gynecologic surgery or major, open urologic procedures (Grade 1A for both groups), with LMWH, LDUH, fondaparinux, or intermittent pneumatic compression (IPC). For patients undergoing elective hip or knee arthroplasty, we recommend one of the following three anticoagulant agents: LMWH, fondaparinux, or a vitamin K antagonist (VKA); international normalized ratio (INR) target, 2.5; range, 2.0 to 3.0 (each Grade 1A). For patients undergoing hip fracture surgery (HFS), we recommend the routine use of fondaparinux (Grade 1A), LMWH (Grade 1B), a VKA (target INR, 2.5; range, 2.0 to 3.0) [Grade 1B], or LDUH (Grade 1B). We recommend that patients undergoing hip or knee arthroplasty or HFS receive thromboprophylaxis for a minimum of 10 days (Grade 1A); for hip arthroplasty and HFS, we recommend continuing thromboprophylaxis > 10 days and up to 35 days (Grade 1A). We recommend that all major trauma and all spinal cord injury (SCI) patients receive thromboprophylaxis (Grade 1A). In patients admitted to hospital with an acute medical illness, we recommend thromboprophylaxis with LMWH, LDUH, or fondaparinux (each Grade 1A). We recommend that, on admission to the ICU, all patients be assessed for their risk of VTE, and that most receive thromboprophylaxis (Grade 1A).
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            Venous thromboembolism and subsequent hospitalisation due to acute arterial cardiovascular events: a 20-year cohort study.

            In some studies, venous thromboembolism has been associated with atherosclerosis and with the risk of arterial cardiovascular events such as myocardial infarction and stroke. Other studies, however, do not show this association. To help clarify these discrepant findings, we aimed to investigate the risk of arterial cardiovascular events in patients who were diagnosed with venous thromboembolism. We undertook a 20-year population-based cohort study using data from nationwide Danish medical databases. After excluding those with known cardiovascular disease, we assessed the risk of myocardial infarction and stroke in 25,199 patients with deep venous thrombosis, 16,925 patients with pulmonary embolism, and 163,566 population controls. For patients with deep venous thrombosis, the relative risks varied from 1.60 for myocardial infarction (95% CI 1.35-1.91) to 2.19 (1.85-2.60) for stroke in the first year after the thrombotic event. For patients with pulmonary embolism, the relative risks in that year were 2.60 (2.14-3.14) for myocardial infarction and 2.93 (2.34-3.66) for stroke. The relative risks were also raised, though less markedly, during the subsequent 20 years of follow-up, with 20-40% increases in risk for arterial cardiovascular events. Relative risks were similar for those with provoked and unprovoked deep venous thrombosis and pulmonary embolism. Patients with venous thromboembolism have a substantially increased long-term risk of subsequent arterial cardiovascular events.
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              Clinical practice. Heparin-induced thrombocytopenia.

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                Author and article information

                Journal
                Open Orthop J
                TOORTHJ
                The Open Orthopaedics Journal
                Bentham Open
                1874-3250
                30 December 2011
                2011
                : 5
                : 395-399
                Affiliations
                [1 ]Department of Orthopaedic Joint Surgery and Endoprosthetics, ENDO-Klinik Hamburg, Germany
                [2 ]Center for Musculoskeletal Surgery Orthopaedic Department, Charité, University Medicine Berlin, Free and Humboldt-University of Berlin, Germany
                [3 ]Endogap Joint Replacement Institute, Klinikum Garmisch-Partenkirchen, Garmisch-Partenkirchen, Germany
                [4 ]Department of Orthopaedic Surgery, OCM Clinic, Munich, Germany
                Author notes
                [* ]Address correspondence to this author at the ENDO-Klinik Hamburg, Holstenstr. 2, D-22767 Hamburg, Germany; Tel: +49 40 3197 1798; Fax: +49 40 3197 1963; E-mail: daniel.kendoff@ 123456endo.de
                Article
                TOORTHJ-5-395
                10.2174/1874325001105010395
                3263520
                22276081
                2bab152b-da09-4272-978b-227f08382656
                © Kendoff et al.; Licensee Bentham Open.

                This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

                History
                : 7 November 2011
                : 20 November 2011
                : 23 November 2011
                Categories
                Article

                Orthopedics
                direct thrombin inhibitor,anticoagulant,dabigatran etexilate,knee replacement surgery,hip replacement surgery,thromboprophylaxis.

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