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January 1, 2015Thrombosis and HaemostasisOpen Access

Edoxaban for treatment of venous thromboembolism in patients with cancer

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Why the study?

Does edoxaban prevent recurrent VTE and major bleeding compared to LMWH in cancer patients with venous thromboembolism?

Population

Patients with cancer and venous thromboembolism, including incidental VTE

Comparison

Edoxaban (oral factor Xa inhibitor) vs Low-molecular-weight heparin (LMWH)

Design

Other, randomised, open-label

Follow-up

12 months

Authors

MNMarcello Di NisioSBSuzanne M. BlekerASAnnelise Segers

Discussion

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Overview

Designs RCT testing edoxaban non-inferiority to LMWH in cancer VTE; extends evidence gaps for long-term anticoagulation in this population.

Key Points

  • This study aims to evaluate if edoxaban is non-inferior to low-molecular-weight heparin for treating venous thromboembolism in cancer patients.
  • Randomised, open-label clinical trial design
  • Composite primary outcome of recurrent VTE and major bleeding over 12 months
  • Enrolment includes cancer patients diagnosed within the past two years and those with incidental VTE.
  • Enrollment of a diverse group of cancer patients with VTE at risk for recurrent VTE
  • Evaluation of long-term treatment outcomes fills existing gaps in evidence for anticoagulation in this population
  • Non-inferiority of edoxaban compared to LMWH will be analyzed, focusing on safety and efficacy.

Structured PICO

Does edoxaban prevent recurrent VTE and major bleeding compared to LMWH in cancer patients with venous thromboembolism?

P
Population
Patients with cancer (diagnosed within the past two years) and venous thromboembolism (VTE), including incidental VTE
I
Intervention
Edoxaban (oral factor Xa inhibitor)
C
Comparator
Low-molecular-weight heparin (LMWH)
O
Outcome
Composite of recurrent VTE and major bleeding during a 12-month study periodcomposite

This paper describes the rationale and design of the Hokusai VTE-cancer study, which evaluates edoxaban versus LMWH for VTE treatment in cancer patients.

Cite This Study

Nisio et al. (2015) studied this question.

synapsesocial.com/papers/6a70bee38031ec7bb1dc8bdehttps://doi.org/10.1160/th15-06-0452
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1A worldwide survey to assess the current approach to the treatment of patients with cancer and venous thromboembolism2013 · 17 citations
  2. 2Epidemiology of cancer-associated venous thrombosis2013 · 1,217 citations
  3. 3Oral Rivaroxaban for the Treatment of Symptomatic Pulmonary Embolism2012 · 2,373 citations
  4. 4Oral Apixaban for the Treatment of Acute Venous Thromboembolism2013 · 2,335 citations
  5. 5Systematic Review: Case-Fatality Rates of Recurrent Venous Thromboembolism and Major Bleeding Events Among Patients Treated for Venous Thromboembolism2010 · 472 citations