Evidence map›Paper›PMID 30123981›Full record

Trial reportBritish journal of haematology2018

Predictive value of venous thromboembolism (VTE)-BLEED to predict major bleeding and other adverse events in a practice-based cohort of patients with VTE: results of the XALIA study.

Frederikus A Klok, Stefano Barco, Alexander G G Turpie, Sylvia Haas, Reinhold Kreutz, Lorenzo G Mantovani, Martin Gebel, Matthias Herpers, Joerg-Peter Bugge, Stavros V Kostantinides and 1 more

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in British journal of haematology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Assessment and mitigation of bleeding risk in atrial fibrillation and venous thromboembolism: A Position Paper from the ESC Working Group on Thrombosis, in collaboration with the European Heart Rhythm Association, the Association for Acute CardioVascular Care and the Asia-Pacific Heart Rhythm Society.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2022
    Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Anticoagulation for Patients with Venous Thromboembolism: When is Extended Treatment Required?TH open : companion journal to thrombosis and haemostasis · 2020
    Review
  12. Article
  13. 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

11 authors.

Frederikus A KlokCentre for Thrombosis and Haemostasis (CTH), University Medical Centre of the Johannes Gutenberg University, Mainz, Germany.ORCID 0000-0001-9961-0754
Stefano BarcoCentre for Thrombosis and Haemostasis (CTH), University Medical Centre of the Johannes Gutenberg University, Mainz, Germany.
Alexander G G TurpieDepartment of Medicine, McMaster University, Hamilton, Canada.
Sylvia HaasDepartment of Medicine, Formerly Technical University of Munich, Munich, Germany.
Reinhold KreutzInstitute of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin, Berlin, Germany.
Lorenzo G MantovaniCESP-Centre for Public Health Research, University of Milan Bicocca, Milan, Italy.
Martin GebelClinStat GmbH, Cologne, Germany.
Matthias HerpersBayer AG, Berlin, Germany.
Joerg-Peter BuggeDepartment of Clinical and Experimental Medicine, University of Insubria, Varese, Italy.
Stavros V KostantinidesCentre for Thrombosis and Haemostasis (CTH), University Medical Centre of the Johannes Gutenberg University, Mainz, Germany.
Walter AgenoDepartment of Clinical and Experimental Medicine, University of Insubria, Varese, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Venous thromboembolism (VTE)-BLEED, a decision tool for predicting major bleeding during chronic anticoagulation for VTE has not yet been validated in practice-based conditions. We calculated the prognostic indices of VTE-BLEED for major bleeding after day 30 and day 90, as well as for recurrent VTE and all-cause mortality, in 4457 patients enrolled in the international, prospective XALIA study. The median at-risk time was 190 days (interquartile range 106-360). The crude hazard ratio (HR) for major bleeding after day 30 was 2·6 [95% confidence interval (CI) 1·3-5·2] and the treatment-adjusted HR was 2·3 (95% CI 1·1-4·5) for VTE-BLEED high (versus low) risk patients: the corresponding values for major bleeding after day 90 were 3·8 (95% CI 1·6-9·3) and 3·2 (95% CI 1·3-7·7), respectively. The predictive value of VTE-BLEED was similar in selected patients with unprovoked VTE or those treated with rivaroxaban. High VTE-BLEED score was associated with higher incidence of all-cause mortality (treatment-adjusted HR 11, 95% CI 4·8-23), but not evidently with recurrent VTE (treatment-adjusted HR 1·5; 95% CI 0·85-2·7). These results confirm the predictive value of VTE-BLEED in practice-based data in patients treated with rivaroxaban or conventional anticoagulation, supporting the hypothesis that VTE-BLEED may be useful for making management decisions on the duration of anticoagulant therapy.

Indexed as

HemorrhageVenous ThromboembolismAdultDisease-Free SurvivalFemaleHumansMaleMiddle AgedPredictive Value of TestsProspective StudiesRivaroxabanSurvival RateYoung AdultRivaroxabananticoagulation therapybleedingpredictionrivaroxabanvenous thromboembolism

Identifiers

PMID30123981
PMCPMC6283241

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Registered trials

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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.