Evidence map›Paper›PMID 29231094›Full record

Trial reportThe New England journal of medicine2018

Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism.

Gary E Raskob, Nick van Es, Peter Verhamme, Marc Carrier, Marcello Di Nisio, David Garcia, Michael A Grosso, Ajay K Kakkar, Michael J Kovacs, Michele F Mercuri and 10 more

3 registry-linked trialsAbstract readEquivalence TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 688 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
688citing papers in PubMed, 15 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02073682 phase3completednot on this map

A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer

TypeinterventionalSponsorDaiichi SankyoRan2015 to 2017Enrolled1,046ConditionsVenous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), CancerArmsEdoxaban, Dalteparin, Low molecular weight heparin
NCT04508855 withdrawnnot on this mapstarted 2020, after this paper: background citation

Safety and Efficacy of Switching From Direct Oral Anticoagulants to Low Molecular Weight Heparin in Cancer Patients With Atrial Fibrillation During Antineoplastic Therapy

TypeobservationalSponsorAHEPA University HospitalRan2020 to 2023Enrolled0ConditionsCancer, Atrial FibrillationArmsLow molecular weight heparin
NCT06393868 phase3recruitingnot on this mapstarted 2024, after this paper: background citation

Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism: Pilot Randomized Study (RADIANT Study)

TypeinterventionalSponsorOttawa Hospital Research InstituteRan2024 to 2028Enrolled360ConditionsVenous Thromboembolism, Gastro Intestinal Bleeding, Blood ClotArmsOmeprazole 20 mg Oral Tablet, Placebo
3 · Its place in the literature

Who cites it

688 citing papers in PubMed, 15 syntheses or guidelines pooled it.

  1. Pooled it
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  11. Brazilian guidelines for the pharmacological treatment of pulmonary embolism. Official document of the Brazilian Thoracic Association based on the GRADE methodology.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2025
    Guideline
  12. SEOM clinical guidelines on venous thromboembolism (VTE) and cancer (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Guideline
  13. Pooled it
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  16. Trial
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628 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors.

Gary E RaskobFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
Nick van EsFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
Peter VerhammeFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
Marc CarrierFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
Marcello Di NisioFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
David GarciaFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
Michael A GrossoFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
Ajay K KakkarFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
Michael J KovacsFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
Michele F MercuriFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
Guy MeyerFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
Annelise SegersFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
Minggao ShiFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
Tzu-Fei WangFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
Erik YeoFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
George ZhangFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
Jeffrey I ZwickerFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
Jeffrey I WeitzFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
Harry R BüllerFrom the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium (P.V.); Ottawa Hospital Research Institute, Ottawa (M.C.), London Health Sciences Centre-Victoria Hospital, London, ON (M.J.K.), University Health Network, University of Toronto, Toronto (E.Y.), and McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON (J.I.W.) - all in Canada; the Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy (M.D.N.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (D.G.); Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.A.G., M.F.M., M.S., G.Z.); Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Respiratory Disease, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris (G.M.); the Department of Internal Medicine, Division of Hematology, Ohio State University Wexner Medical Center, Columbus (T.-F.W.); and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.I.Z.).
Hokusai VTE Cancer Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLow-molecular-weight heparin is the standard treatment for cancer-associated venous thromboembolism. The role of treatment with direct oral anticoagulant agents is unclear.

methodsIn this open-label, noninferiority trial, we randomly assigned patients with cancer who had acute symptomatic or incidental venous thromboembolism to receive either low-molecular-weight heparin for at least 5 days followed by oral edoxaban at a dose of 60 mg once daily (edoxaban group) or subcutaneous dalteparin at a dose of 200 IU per kilogram of body weight once daily for 1 month followed by dalteparin at a dose of 150 IU per kilogram once daily (dalteparin group). Treatment was given for at least 6 months and up to 12 months. The primary outcome was a composite of recurrent venous thromboembolism or major bleeding during the 12 months after randomization, regardless of treatment duration.

resultsOf the 1050 patients who underwent randomization, 1046 were included in the modified intention-to-treat analysis. A primary-outcome event occurred in 67 of the 522 patients (12.8%) in the edoxaban group as compared with 71 of the 524 patients (13.5%) in the dalteparin group (hazard ratio, 0.97; 95% confidence interval [CI], 0.70 to 1.36; P=0.006 for noninferiority; P=0.87 for superiority). Recurrent venous thromboembolism occurred in 41 patients (7.9%) in the edoxaban group and in 59 patients (11.3%) in the dalteparin group (difference in risk, -3.4 percentage points; 95% CI, -7.0 to 0.2). Major bleeding occurred in 36 patients (6.9%) in the edoxaban group and in 21 patients (4.0%) in the dalteparin group (difference in risk, 2.9 percentage points; 95% CI, 0.1 to 5.6).

conclusionsOral edoxaban was noninferior to subcutaneous dalteparin with respect to the composite outcome of recurrent venous thromboembolism or major bleeding. The rate of recurrent venous thromboembolism was lower but the rate of major bleeding was higher with edoxaban than with dalteparin. (Funded by Daiichi Sankyo; Hokusai VTE Cancer ClinicalTrials.gov number, NCT02073682 .).

Indexed as

AdultAgedAnticoagulantsDalteparinFollow-Up StudiesHemorrhageHeparin, Low-Molecular-WeightHumansIntention to Treat AnalysisKaplan-Meier EstimateMaleMiddle AgedNeoplasmsPyridinesRecurrenceThiazolesAnticoagulantsDalteparinedoxabanHeparin, Low-Molecular-WeightPyridinesThiazoles

Identifiers

PMID29231094

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