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Stroke prevention with aspirin, warfarin and ximelagatran in patients with non-valvular atrial fibrillation: a systematic review and meta-analysis

OBJECTIVE: To compare the effectiveness of aspirin, warfarin, and ximelagatran as thromboprophylaxis in patients with non-valvular atrial fibrillation (NVAF).

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2006

Safety and efficacy of ximelagatran: meta-analysis of the controlled randomized trials for the prophylaxis or treatment of venous thromboembolism

BACKGROUND: Ximelagatran has been approved in Europe for VTE prophylaxis in orthopedic surgery at fixed doses and without laboratory monitoring. Aim of the study was to evaluate safety and efficacy of ximelagatran in a meta-analysis of prophylaxis and/or treatment randomized controlled trials.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2005

Meta-analysis of trials comparing ximelagatran with low molecular weight heparin for prevention of venous thromboembolism after major orthopaedic surgery

BACKGROUND: Use of low molecular weight heparin (LMWH) is standard practice for preventing postoperative venous thromboembolism (VTE). Ximelagatran is a new direct thrombin inhibitor for this indication.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2005

Ximelagatran/melagatran against conventional anticoagulation: a meta-analysis based on 22,639 patients

The authors concluded that ximelagatran/melagatran had comparable efficacy to conventional anti-coagulant therapy in the rate of major adverse events and major bleeds, but that it carried a prohibitive risk of hepatic toxicity. The manufacturer has withdrawn ximelagatran/melagatran. This was a generally well-conducted review, but the unknown quality of included trials means that the reliability of the authors' conclusions is unclear.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2007

Lessons from ximelagatran: issues for future studies evaluating new oral direct thrombin inhibitors for venous thromboembolism prophylaxis in orthopedic surgery

The authors concluded that the risk-benefit profile of ximelagatran used as thromboprophylaxis in total hip and knee replacement surgery depended on the surgery type, initial timing of administration and probably dose. This was generally a well-conducted review, but given the limited number and heterogeneous nature of the studies, the conclusion should be treated with caution.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2009

Ximelagatran versus warfarin for prophylaxis of venous thromboembolism in major orthopedic surgery: systematic review of randomized controlled trials

This review evaluated ximelagatran as prophylactic treatment in older patients undergoing knee surgery. The authors concluded that a higher dose of ximelagatran is more effective than warfarin in reducing the incidence of venous thromboembolism, but it increases the frequency of alanine aminotranferase elevation in the follow-up period. This was a well-conducted review and the conclusions are likely to be reliable. Ximelagatran has since been withdrawn from the market.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2006

Outcomes of Genetic Testing in Adults with a History of Venous Thromboembolism

To address whether Factor V Leiden (FVL) testing alone, or in combination with prothrombin G20210A testing, leads to improved clinical outcomes in adults with a personal history of venous thromboembolism (VTE) or to improved clinical outcomes in adult family members of mutation-positive individuals.

Evidence Reports/Technology Assessments - Agency for Healthcare Research and Quality (US).

Version: June 2009
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Direct thrombin inhibitors compared with vitamin K antagonists in people with atrial fibrillation for preventing stroke

Question: We wanted to compare the effectiveness and safety of direct thrombin inhibitors (DTIs) with vitamin K antagonists in people with atrial fibrillation (AF) to prevent stroke.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2016

Blood thinners for the long‐term treatment of blood clots in patients with cancer

Patients with cancer are at an increased risk of developing blood clots and might respond differently to blood thinners (anticoagulants) compared with patients without cancer.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2014

New types of anticoagulants to prevent deep vein thrombosis and pulmonary embolism following total hip or knee replacement surgery

Venous thromboembolism is the presence of a blood clot that blocks a blood vessel within the venous system; it includes deep vein thrombosis (DVT) and pulmonary embolism (PE) which can be fatal. Venous thromboembolism occurs in 44% to 90% of those patients who undergo total hip or knee replacement and who do not receive anticoagulants (blood thinning drugs).

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2011

Comparative Effectiveness of Warfarin and Newer Oral Anticoagulants for the Long-Term Prevention and Treatment of Arterial and Venous Thromboembolism [Internet]

The Veterans Health Administration (VHA) System serves a largely older, male population with a high prevalence of chronic atrial fibrillation (AF) and venous thromboembolism (VTE). Many veterans with chronic AF have risk profiles for stroke that, according to current clinical guidelines, place them in a risk group where chronic anticoagulation is recommended. Adjusted-dose warfarin has been the preferred approach to chronic anticoagulation in the VHA, and in many VHA settings, specialized therapeutic drug-monitoring services provide high-quality warfarin treatment. However, the advent of newer anticoagulants with the promise of simplified long-term anticoagulation requires reconsideration of current treatment practices. The purpose of this systematic review was to study the comparative effectiveness of warfarin and the newer oral anticoagulants used for the long-term prevention and treatment of arterial and venous thromboembolism. An evaluation of newer oral anticoagulants for VTE prophylaxis in the perioperative period will be the subject of a later report.

Evidence-Based Synthesis Program - Department of Veterans Affairs (US).

Version: April 2012
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Novel oral anticoagulants for the treatment of deep vein thrombosis

Deep vein thrombosis (DVT) is a condition in which a blood clot forms in the deep vein of the leg or pelvis. It affects approximately 1 in 1000 people. If it is not treated, the clot can travel in the blood and block the arteries in the lungs. This life‐threatening condition is called a pulmonary embolism (PE) and occurs in approximately 3 to 4 per 10,000 people. The chances of getting a DVT can be increased if people have certain risk factors. These include previous clots, prolonged periods of immobility (such as travelling on aeroplanes or bed rest), cancer, exposure to oestrogens (pregnancy, oral contraceptives or hormone replacement therapy), trauma and blood disorders such as thrombophilia (abnormal blood clotting). A DVT is diagnosed through determining the risk factors and performing an ultrasound of the leg veins. If a DVT is confirmed, people are treated with an anticoagulant. This medicine prevents further clots from forming. Until recently, the drugs of choice were heparin, fondaparinux and vitamin K antagonists. However, these drugs can cause side effects and have limitations. Two further classes of novel oral anticoagulants have been developed: these are called direct thrombin inhibitors (DTI) and factor Xa inhibitors. There are particular reasons why oral DTIs and factor Xa inhibitors might now be better medicines to use. They can be given orally, they have a predictable effect, they do not require frequent monitoring or re‐dosing and they have few known drug interactions. This review measures the effectiveness and safety of these new drugs with conventional treatment.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2015

Combined anticoagulation and antiplatelet therapy for high-risk patients with atrial fibrillation: a systematic review

Study finds that there is still insufficient evidence to advocate a clear benefit of the addition of anti-platelet therapy to anticoagulant therapy, compared with anticoagulant therapy alone, in reducing the risk of vascular events in a population of patients who are at high risk of thromboembolic events resulting from atrial fibrillation

Health Technology Assessment - NIHR Journals Library.

Version: July 2013
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Safety, Effectiveness, and Cost-Effectiveness of New Oral Anticoagulants Compared with Warfarin in Preventing Stroke and Other Cardiovascular Events in Patients with Atrial Fibrillation [Internet]

Approximately 250,000 Canadians are affected by atrial fibrillation (AF). Stroke is a complication of AF, and Canadians with AF are five times more likely to have a stroke and are twice as likely to die than individuals without AF. AF and stroke are more common among the elderly.

CADTH Therapeutic Review - Canadian Agency for Drugs and Technologies in Health.

Version: April 9, 2012
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Atrial Fibrillation: The Management of Atrial Fibrillation

Atrial fibrillation (AF) is a very common problem. In England alone, approximately 835,000 people have AF.321 Through its effects on rate and rhythm, it is a major cause of morbidity. Through increasing susceptibility to stroke, it is a major cause of both morbidity and mortality.

NICE Clinical Guidelines - National Clinical Guideline Centre (UK).

Version: June 2014
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Head Injury: Triage, Assessment, Investigation and Early Management of Head Injury in Children, Young People and Adults

For the purposes of this guideline, head injury is defined as any trauma to the head other than superficial injuries to the face. Head injury is the commonest cause of death and disability in people aged 1–40 years in the UK. Data for head injury are recorded in the Hospital Episode Statistics (http://www.hscic.gov.uk/hes). Each year, 1.4 million people attend emergency departments in England and Wales with a recent head injury. Between 33% and 50% of these are children aged under 15 years. Annually, about 200,000 people are admitted to hospital with head injury. Of these, one-fifth have features suggesting skull fracture or have evidence of brain damage. Most patients recover without specific or specialist intervention, but others experience long-term disability or even die from the effects of complications that could potentially be minimised or avoided with early detection and appropriate treatment.

NICE Clinical Guidelines - National Clinical Guideline Centre (UK).

Version: January 2014
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Safe and Effective Anticoagulation in the Outpatient Setting: A Systematic Review of the Evidence [Internet]

The primary objectives of this systematic review were to: 1. Determine whether specialized anticoagulation clinics (ACC) are more effective and safer than care in non-specialized clinics (e.g., primary care clinics, physician offices) for management of long- term anticoagulation in adults; 2. Determine whether patient self testing (PST), either alone or in combination with patient self management (PSM), is more effective and safer than standard care; and 3. Identify the risk factors for serious bleeding in patients on chronic anticoagulant therapy.

Evidence-based Synthesis Program - Department of Veterans Affairs (US).

Version: February 2011
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Venous Thromboembolism Prophylaxis in Orthopedic Surgery [Internet]

This is an evidence report prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center (EPC) examining the comparative efficacy and safety of prophylaxis for venous thromboembolism in major orthopedic surgery (total hip replacement [THR], total knee replacement [TKR], and hip fracture surgery [HFS]) and other nonmajor orthopedic surgeries (knee arthroscopy, injuries distal to the hip requiring surgery, and elective spine surgery).

Comparative Effectiveness Reviews - Agency for Healthcare Research and Quality (US).

Version: March 2012
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Coronary and mortality risk of novel oral antithrombotic agents: a meta-analysis of large randomised trials

OBJECTIVE: Oral direct thrombin and anti-Xa inhibitors have been shown to be efficacious in the prevention and treatment of venous thromboembolism, and prevention of embolic events in atrial fibrillation. Recent studies showed that dabigatran may be associated with increased rates of myocardial infarction (MI). Coronary risk for the other agents was unclear. The aim of the study is to determine the coronary risk among four novel antithrombotic agents.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

New oral anticoagulants for the treatment of acute venous thromboembolism: are they safer than vitamin K antagonists? A meta-analysis of the interventional trials

New oral anticoagulants (NOACs) may represent an alternative to standard therapy with vitamin K antagonists (VKA). However, up to the present, it is unknown whether these drugs are safer than VKA. The aim of this study was to perform a meta-analysis of the interventional trials with NOACs vs VKA in patients with acute venous thromboembolism (VTE) to obtain the balance between clinical efficacy and complications. A meta-analysis of double blind randomized controlled trials (RCTs) was performed. We included RCTs that compared, in acute VTE, the beneficial and harmful effects of NOACs (ximelagatran, apixaban, dabigatran, edoxaban and rivaroxaban) vs VKA (warfarin). Seven studies including 29,482 patients were selected. Compared with warfarin, recurrent VTE and death from any cause were not significantly reduced by NOACs. Myocardial infarction was significantly increased with NOACs compared with warfarin (RR 2.55; 95 % CI 1.1-5.6; p = 0.02). NOACs significantly reduced the major bleedings (RR 0.63; 95 % CI 0.47-0.83; p = 0.001). This meta-analysis suggests that treatment with NOACs in patients with acute VTE is not inferior to conventional therapy with warfarin for recurrent VTE and death from any cause, but there might be an increased incidence of myocardial infarction.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

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