Evidence map›Paper›PMID 35992565›Full record

ArticleResearch and practice in thrombosis and haemostasis2022

Postthrombotic syndrome and quality of life after deep vein thrombosis in patients treated with edoxaban versus warfarin.

Ingrid M Bistervels, Roisin Bavalia, Jan Beyer-Westendorf, Arina J Ten Cate-Hoek, Sebastian M Schellong, Michael J Kovacs, Nicolas Falvo, Karina Meijer, Dominique Stephan, Wim G Boersma and 25 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Research and practice in thrombosis and haemostasis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 16% of its field
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.

NCT00986154 phase3completednot on this map

A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).

TypeinterventionalSponsorDaiichi SankyoRan2009 to 2013Enrolled8,292ConditionsVenous Thromboembolism, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), ThromboembolismArmsedoxaban tosylate(DU-176b), low molecular weight heparin/unfractionated heparin, warfarin
NCT03757481 nacompletednot on this map

Long-term Outcome After Heparin and Edoxaban Versus Heparin Plus Vitamin K Antagonists for Acute Deep Vein Thrombosis and Pulmonary Embolism HOKUSAÏ POST VT

TypeinterventionalSponsorUniversity Hospital, MontpellierRan2018 to 2020Enrolled156ConditionsPost Thrombotic Syndrome, Deep Vein Thrombosis, Chronic Thromboembolic Pulmonary HypertensionArmsno intervention
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

35 authors at 20 institutions in 9 countries.

Ingrid M BistervelsDepartment of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam UMC University of Amsterdam Amsterdam The Netherlands.ORCID https://orcid.org/0000-0002-1155-4143
Roisin BavaliaDepartment of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam UMC University of Amsterdam Amsterdam The Netherlands.ORCID https://orcid.org/0000-0002-1806-1050
Jan Beyer-WestendorfDepartment of Medicine I, Division of Hematology and Hemostasis, Thrombosis Research University Hospital "Carl Gustav Carus" Dresden Dresden Germany.ORCID https://orcid.org/0000-0002-6983-9993
Arina J Ten Cate-HoekThrombosis Expertise Centre, Heart+Vascular Center Maastricht University Medical Centre Maastricht The Netherlands.
Sebastian M SchellongMedizinische Klinik, Städtisches Klinikum Dresden Dresden Germany.
Michael J KovacsDepartment of Hematology and Thrombosis London Health Sciences Centre,Victoria Hospital London Ontario Canada.
Nicolas FalvoDepartment of Internal Medicine and Immunology Centre Hospitalier Regionale Universitaire Dijon Dijon France.
Karina MeijerDepartment of Hematology University Medical Centre Groningen Groningen The Netherlands.ORCID https://orcid.org/0000-0001-9447-0465
Dominique StephanDepartment of Hypertension, Vascular Disease and Clinical Pharmacology Regional University Hospital Strasbourg France.
Wim G BoersmaDepartment of Pulmonology Noordwest Ziekenhuisgroep Alkmaar The Netherlands.
Marije Ten WoldeDepartment of Internal Medicine Flevo Hospital Almere The Netherlands.
Francis CouturaudDepartment of Pulmonology Centre Hospitalier Regionale Universitaire Brest Brest France.ORCID https://orcid.org/0000-0002-1855-8032
Peter VerhammeDepartment of Vascular Medicine and Hemostasis University Hospital Leuven Leuven Belgium.ORCID https://orcid.org/0000-0001-8698-2858
Dominique BrisotDepartment of Vascular Medicine Clinique du Parc Castelnau le Lez France.
Susan R KahnDepartment of Medicine McGill University Montreal Canada.ORCID https://orcid.org/0000-0002-5667-8916
Waleed GhanimaDepartment of Research, Østfold Hospital and Institute of Clinical Medicine University of Oslo Oslo Norway.
Karine MontaclairDepartment of Cardiology Centre Hospitalier Le Mans Le Mans France.
Amanda HugmanDepartment of Haematology St George Hospital Sydney New South Wales Australia.
Patrick CarrollDepartment of Vascular Medicine Redcliffe Hospital Queensland Australia.
Gilles PernodDepartment of Medicine Centre Hospitalier Regionale Universitaire de Grenoble-Alpes Grenoble France.
Olivier SanchezDepartment of Pulmonology Hôpital Européen Georges-Pompidou Paris France.ORCID https://orcid.org/0000-0003-1633-8391
Emile FerrariDepartment of Cardiology Centre Hospitalier Universitaire de Nice Nice France.
Pierre-Marie RoyDepartment of Emergency Medicine Centra Hospitalier Universitaire d'Angers Angers France.
Marie-Antoinette Sevestre-PietriDepartment of Medicine Centre Hospitalier Regionale Universitaire d'Amiens Amiens France.
Simone BirocchiDepartment of Hematology and Thrombosis SanPaolo Hospital Milan Italy.
Hilde S WikDepartment of Haematology Oslo University Hospital Oslo Norway.ORCID https://orcid.org/0000-0002-1035-5521
Barbara A HuttenDepartment of Epidemiology and Data Science, Amsterdam Cardiovascular Sciences Amsterdam UMC, University of Amsterdam Amsterdam The Netherlands.ORCID https://orcid.org/0000-0002-9243-0037
Michiel CoppensDepartment of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam UMC University of Amsterdam Amsterdam The Netherlands.ORCID https://orcid.org/0000-0001-6891-9062
Christiane NaueDepartment of Medicine I, Division of Hematology and Hemostasis, Thrombosis Research University Hospital "Carl Gustav Carus" Dresden Dresden Germany.
Michael A GrossoDaiichi Sankyo Pharma Development Basking Ridge New Jersey USA.
Minggao ShiDaiichi Sankyo Pharma Development Basking Ridge New Jersey USA.
Yong LinDaiichi Sankyo Pharma Development Basking Ridge New Jersey USA.
Isabelle QuéréDepartment of Vascular Medicine IDESP Inserm-Montpellier University, InnoVTE Network, CHU Montpellier Montpellier France.
Saskia MiddeldorpDepartment of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam UMC University of Amsterdam Amsterdam The Netherlands.ORCID https://orcid.org/0000-0002-1006-6420
Hokusai PTS Investigators
Amsterdam Neuroscience · NLDaiichi Sankyo (United States) · USOslo University Hospital · NOUniversity Hospital Carl Gustav Carus · DECentre Hospitalier du Mans · FRCentre Hospitalier Régional Universitaire de Brest · FRCentre Hospitalier Universitaire Amiens-Picardie · FRCentre Hospitalier Universitaire d'Angers · FRCentre Hospitalier Universitaire de Grenoble · FRCentre Hospitalier Universitaire de Nice · FRCHU Dijon Bourgogne · FRClinique Ambroise Paré · FRDe Kinderkliniek · NLHôpital Européen Georges-Pompidou · FRInserm · FRKU Leuven · BELondon Health Sciences Centre · CAMaastricht University Medical Centre · NLMcGill University · CANoordwest Ziekenhuisgroep · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Postthrombotic syndrome (PTS) is a long-term complication after deep vein thrombosis (DVT) and can affect quality of life (QoL). Pathogenesis is not fully understood but inadequate anticoagulant therapy with vitamin K antagonists is a known risk factor for the development of PTS. Objectives: To compare the prevalence of PTS after acute DVT and the long-term QoL following DVT between patients treated with edoxaban or warfarin. Methods: We performed a long-term follow-up study in a subset of patients with DVT who participated in the Hokusai-VTE trial between 2010 and 2012 (NCT00986154). Primary outcome was the prevalence of PTS, defined by the Villalta score. The secondary outcome was QoL, assessed by validated disease-specific (VEINES-QOL) and generic health-related (SF-36) questionnaires. Results: Between 2017 and 2020, 316 patients were enrolled in 26 centers in eight countries, of which 168 (53%) patients had been assigned to edoxaban and 148 (47%) to warfarin during the Hokusai-VTE trial. Clinical, demographic, and thrombus-specific characteristics were comparable for both groups. Mean (SD) time since randomization in the Hokusai-VTE trial was 7.0 (1.0) years. PTS was diagnosed in 85 (51%) patients treated with edoxaban and 62 (42%) patients treated with warfarin (adjusted odds ratio 1.6, 95% CI 1.0-2.6). Mean differences in QoL scores between treatment groups were not clinically relevant. Conclusion: Contrary to our hypothesis, the prevalence of PTS tended to be higher in patients treated with edoxaban compared with warfarin. No differences in QoL were observed. Further research is warranted to unravel the role of anticoagulant therapy on development of PTS.

Indexed as

edoxabanpostthrombotic syndromequality of lifevenous thrombosiswarfarin

Identifiers

PMID35992565
PMCPMC9248314
OpenAlexW4283774248

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.