Cost-Effectiveness of Dabigatran Etexilate for the Secondary Prevention of Recurrent Deep Vein Thrombosis and Pulmonary Embolism in the United Kingdom

The standard treatment for acute deep vein thrombosis (DVT) targets to reduce immediate complications, however thrombolysis could reduce the long-term complications of post-thrombotic syndrome in the affected limb. This systematic review aimed to assess the effects of thrombolytic therapy and anticoagulation versus anticoagulation in people with deep vein thrombosis of the lower limb through the effects on pulmonary embolism, recurrent deep vein thrombosis, major bleeding, post-thrombotic complications, venous patency and venous function. The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last search in April 2013) and CENTRAL (2013, Issue 4). A total of 17 randomised controlled trials (RCTs) and 1103 participants were included. In the experimental group receiving thrombolysis, complete clot lysis occurred more frequently and there was greater improvement in venous patency. The incidence of post-thrombotic syndrome decreased by a 1/3 and venous ulcers were less frequent. There were more bleeding complications and 3 strokes occurred in less recent studies, yet there seemed to be no significant effect on mortality. Data on the occurrence of pulmonary embolism and recurrent deep vein thrombosis were inconclusive. There are advantages to thrombolysis, yet the application of rigorous criteria is warranted to reduce bleeding complications. Catheter-directed thrombolysis is the current preferred method, as opposed to systemic thrombolysis in the past, and other studies comparing these procedures show that results are similar.Keywords: Randomized Controlled Trials as Topic; Thrombolytic Therapy; Venous Thrombosis.

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Recurrent deep vein thrombosis and pulmonary embolism in a young man with Klinefelterʼs syndrome and heterozygous mutation of MTHFR-677C>T and 1298A>C

Blood Coagulation & Fibrinolysis ◽

10.1097/mbc.0b013e32833894eb ◽

2010 ◽

Vol 21 (4) ◽

pp. 372-375 ◽

Cited By ~ 6

Author(s):

Joel R Angel ◽

Stacey Parker ◽

Ryan E Sells ◽

Ehab Atallah

Keyword(s):

Pulmonary Embolism ◽

Deep Vein Thrombosis ◽

Heterozygous Mutation ◽

Vein Thrombosis ◽

Recurrent Deep Vein Thrombosis ◽

Deep Vein

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National survey in the United Kingdom of prophylaxis of deep vein thrombosis for patients with fracture of the neck of the femur

Injury ◽

10.1016/j.injury.2005.12.020 ◽

2006 ◽

Vol 37 (8) ◽

pp. 721-726 ◽

Cited By ~ 7

Author(s):

R. Rajaganeshan ◽

C.U. Dussa ◽

V. Sahni

Keyword(s):

United Kingdom ◽

Deep Vein Thrombosis ◽

National Survey ◽

Vein Thrombosis ◽

The United Kingdom ◽

Deep Vein

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American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism

Blood Advances ◽

10.1182/bloodadvances.2020001830 ◽

2020 ◽

Vol 4 (19) ◽

pp. 4693-4738 ◽

Cited By ~ 2

Author(s):

Thomas L. Ortel ◽

Ignacio Neumann ◽

Walter Ageno ◽

Rebecca Beyth ◽

Nathan P. Clark ◽

...

Keyword(s):

Pulmonary Embolism ◽

Deep Vein Thrombosis ◽

Venous Thromboembolism ◽

Secondary Prevention ◽

Conflicts Of Interest ◽

The United States ◽

Primary Treatment ◽

Vein Thrombosis ◽

American Society ◽

Deep Vein

Background: Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), occurs in ∼1 to 2 individuals per 1000 each year, corresponding to ∼300 000 to 600 000 events in the United States annually. Objective: These evidence-based guidelines from the American Society of Hematology (ASH) intend to support patients, clinicians, and others in decisions about treatment of VTE. Methods: ASH formed a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline development process, including updating or performing systematic evidence reviews. The panel prioritized clinical questions and outcomes according to their importance for clinicians and adult patients. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess evidence and make recommendations, which were subject to public comment. Results: The panel agreed on 28 recommendations for the initial management of VTE, primary treatment, secondary prevention, and treatment of recurrent VTE events. Conclusions: Strong recommendations include the use of thrombolytic therapy for patients with PE and hemodynamic compromise, use of an international normalized ratio (INR) range of 2.0 to 3.0 over a lower INR range for patients with VTE who use a vitamin K antagonist (VKA) for secondary prevention, and use of indefinite anticoagulation for patients with recurrent unprovoked VTE. Conditional recommendations include the preference for home treatment over hospital-based treatment for uncomplicated DVT and PE at low risk for complications and a preference for direct oral anticoagulants over VKA for primary treatment of VTE.

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Comparative Efficacy and Safety Of Dabigatran Etexilate and Rivaroxaban For The Treatment Of Deep Vein Thrombosis and Pulmonary Embolism

Blood ◽

10.1182/blood.v122.21.4807.4807 ◽

2013 ◽

Vol 122 (21) ◽

pp. 4807-4807

Author(s):

Andreas Clemens ◽

Shaun Abeysinghe ◽

Ann-Katrin Gonschior ◽

Volker Hösel ◽

Sarah Lock ◽

...

Keyword(s):

Pulmonary Embolism ◽

Deep Vein Thrombosis ◽

Lower Risk ◽

Dabigatran Etexilate ◽

Efficacy And Safety ◽

Bleeding Events ◽

Vein Thrombosis ◽

All Cause Mortality ◽

Meta Analyses ◽

Deep Vein

Objective Two novel oral anticoagulants recently have been investigated for the treatment of deep vein thrombosis and/or pulmonary embolism: dabigatran etexilate (dabigatran) and rivaroxaban. The aim of this analysis was to compare their efficacy and safety. Methods Randomized, controlled trials investigating dabigatran or rivaroxaban were identified by a systematic review. Direct meta-analyses and anchored (adjusted) indirect comparisons (AICs) were performed using aggregated results for the following endpoints for the overall treatment duration: first recurrent symptomatic venous thromboembolism (VTE) or VTE-related death, major bleeding events (MBEs), MBEs or clinically relevant bleeding events (CRBEs), and all-cause mortality. Results Four trials were identified; two compared dabigatran with warfarin and two compared rivaroxaban with vitamin K antagonists. The results of the trials, and the direct meta-analyses of the two dabigatran trials and the two rivaroxaban trials, are presented in Table 1. Overall, there was little evidence of heterogeneity in treatment effects among the RE-COVER trials (VTE or VTE-related death, MBEs, MBEs or CRBEs, all-cause mortality: P= 0.82, 0.67, 0.97, 0.97, respectively; I2= 0%). There was some evidence of heterogeneity among the EINSTEIN trials for VTE or VTE-related death (P=0.11; I2=61.9%) and all-cause mortality (P=0.16; I2=50%), but none for MBEs and MBEs/CRBEs with I2= 0% (P= 0.43, 0.47). In the AICs, sensitivity analyses were performed to explore potential trial heterogeneity arising from differences in the type of index VTE and time with an international normalized ratio between 2.0 and 3.0. AIC results suggested that dabigatran was associated with a lower risk of MBEs/CRBEs than rivaroxaban (upper 95% confidence limits for relative risks were less than 1.00). There was no evidence to suggest a difference between dabigatran and rivaroxaban with respect to prevention of recurrent symptomatic VTE or VTE-related death, MBEs, or all-cause mortality. Conclusions Dabigatran may be associated with a lower risk of major or clinically relevant bleeding; there was no evidence to suggest a difference among drugs in prevention of recurrent VTE, MBEs, or overall mortality. Disclosures: Clemens: Boehringer Ingelheim Pharma GmbH & Co. KG: Employment. Off Label Use: Dabigatran etexilate, direct oral thrombin inhibitor, anticoagulant effect; indications for stroke prevention in atrial fibrillation patients in about 90 countries including US; indication for primary VTE prevention in total hip or knee replacement patients in about 100 countries excluding US. Abeysinghe:Boehringer Ingelheim International GmbH: Consultancy. Gonschior:Boehringer Ingelheim GmbH: Employment. Hösel:Boehringer Ingelheim GmbH: Consultancy. Lock:Boehringer Ingelheim International GmbH: Consultancy. Wolowacz:Boehringer Ingelheim International GmbH: Consultancy. Woods:Boehringer Ingelheim International GmbH: Consultancy. Zimovetz:Boehringer Ingelheim International GmbH: Consultancy.

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