Evidence map›Paper›PMID 28500254›Full record

Trial reportCirculation. Heart failure2017

Increased Thromboembolic Events With Dabigatran Compared With Vitamin K Antagonism in Left Ventricular Assist Device Patients: A Randomized Controlled Pilot Trial.

Martin Andreas, Roxana Moayedifar, Georg Wieselthaler, Michael Wolzt, Julia Riebandt, Thomas Haberl, Philipp Angleitner, Thomas Schlöglhofer, Dominik Wiedemann, Heinrich Schima and 2 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation. Heart failure, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02872649 (Pilot-Trial), which is not on this map. Cited by 35 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 3 pooled it
5.9field-weighted citation impact, top 3% 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.

NCT02872649 phase2terminatednot on this map

Pilot-Trial: Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device

TypeinterventionalSponsorDaniel Zimpfer, MDRan2013 to 2016Enrolled16ConditionsThrombosis, BleedingArmsDabigatran, Phenprocoumon
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 3 syntheses or guidelines pooled it, 99 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
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  6. Review
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  17. Direct Oral Anticoagulants Versus Vitamin K Antagonists in the Treatment of Left Ventricular Thrombi.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2022
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 2 countries.

Martin AndreasFrom the Division of Cardiac Surgery (M.A., R.M., J.R., T.H., P.A., D.W., H.S., G.L., D.Z.), Department of Clinical Pharmacology (M.W.), and Center for Medical Physics and Biomedical Engineering and Ludwig-Boltzmann-Cluster for Cardiovascular Research (T.S., H.S.), Medical University of Vienna, Austria; and Division of Adult Cardiothoracic Surgery, University of California, San Francisco School of Medicine (G.W.). martin.andreas@meduniwien.ac.at.
Roxana MoayedifarFrom the Division of Cardiac Surgery (M.A., R.M., J.R., T.H., P.A., D.W., H.S., G.L., D.Z.), Department of Clinical Pharmacology (M.W.), and Center for Medical Physics and Biomedical Engineering and Ludwig-Boltzmann-Cluster for Cardiovascular Research (T.S., H.S.), Medical University of Vienna, Austria; and Division of Adult Cardiothoracic Surgery, University of California, San Francisco School of Medicine (G.W.).
Georg WieselthalerFrom the Division of Cardiac Surgery (M.A., R.M., J.R., T.H., P.A., D.W., H.S., G.L., D.Z.), Department of Clinical Pharmacology (M.W.), and Center for Medical Physics and Biomedical Engineering and Ludwig-Boltzmann-Cluster for Cardiovascular Research (T.S., H.S.), Medical University of Vienna, Austria; and Division of Adult Cardiothoracic Surgery, University of California, San Francisco School of Medicine (G.W.).
Michael WolztFrom the Division of Cardiac Surgery (M.A., R.M., J.R., T.H., P.A., D.W., H.S., G.L., D.Z.), Department of Clinical Pharmacology (M.W.), and Center for Medical Physics and Biomedical Engineering and Ludwig-Boltzmann-Cluster for Cardiovascular Research (T.S., H.S.), Medical University of Vienna, Austria; and Division of Adult Cardiothoracic Surgery, University of California, San Francisco School of Medicine (G.W.).
Julia RiebandtFrom the Division of Cardiac Surgery (M.A., R.M., J.R., T.H., P.A., D.W., H.S., G.L., D.Z.), Department of Clinical Pharmacology (M.W.), and Center for Medical Physics and Biomedical Engineering and Ludwig-Boltzmann-Cluster for Cardiovascular Research (T.S., H.S.), Medical University of Vienna, Austria; and Division of Adult Cardiothoracic Surgery, University of California, San Francisco School of Medicine (G.W.).
Thomas HaberlFrom the Division of Cardiac Surgery (M.A., R.M., J.R., T.H., P.A., D.W., H.S., G.L., D.Z.), Department of Clinical Pharmacology (M.W.), and Center for Medical Physics and Biomedical Engineering and Ludwig-Boltzmann-Cluster for Cardiovascular Research (T.S., H.S.), Medical University of Vienna, Austria; and Division of Adult Cardiothoracic Surgery, University of California, San Francisco School of Medicine (G.W.).
Philipp AngleitnerFrom the Division of Cardiac Surgery (M.A., R.M., J.R., T.H., P.A., D.W., H.S., G.L., D.Z.), Department of Clinical Pharmacology (M.W.), and Center for Medical Physics and Biomedical Engineering and Ludwig-Boltzmann-Cluster for Cardiovascular Research (T.S., H.S.), Medical University of Vienna, Austria; and Division of Adult Cardiothoracic Surgery, University of California, San Francisco School of Medicine (G.W.).
Thomas SchlöglhoferFrom the Division of Cardiac Surgery (M.A., R.M., J.R., T.H., P.A., D.W., H.S., G.L., D.Z.), Department of Clinical Pharmacology (M.W.), and Center for Medical Physics and Biomedical Engineering and Ludwig-Boltzmann-Cluster for Cardiovascular Research (T.S., H.S.), Medical University of Vienna, Austria; and Division of Adult Cardiothoracic Surgery, University of California, San Francisco School of Medicine (G.W.).
Dominik WiedemannFrom the Division of Cardiac Surgery (M.A., R.M., J.R., T.H., P.A., D.W., H.S., G.L., D.Z.), Department of Clinical Pharmacology (M.W.), and Center for Medical Physics and Biomedical Engineering and Ludwig-Boltzmann-Cluster for Cardiovascular Research (T.S., H.S.), Medical University of Vienna, Austria; and Division of Adult Cardiothoracic Surgery, University of California, San Francisco School of Medicine (G.W.).
Heinrich SchimaFrom the Division of Cardiac Surgery (M.A., R.M., J.R., T.H., P.A., D.W., H.S., G.L., D.Z.), Department of Clinical Pharmacology (M.W.), and Center for Medical Physics and Biomedical Engineering and Ludwig-Boltzmann-Cluster for Cardiovascular Research (T.S., H.S.), Medical University of Vienna, Austria; and Division of Adult Cardiothoracic Surgery, University of California, San Francisco School of Medicine (G.W.).
Guenther LauferFrom the Division of Cardiac Surgery (M.A., R.M., J.R., T.H., P.A., D.W., H.S., G.L., D.Z.), Department of Clinical Pharmacology (M.W.), and Center for Medical Physics and Biomedical Engineering and Ludwig-Boltzmann-Cluster for Cardiovascular Research (T.S., H.S.), Medical University of Vienna, Austria; and Division of Adult Cardiothoracic Surgery, University of California, San Francisco School of Medicine (G.W.).
Daniel ZimpferFrom the Division of Cardiac Surgery (M.A., R.M., J.R., T.H., P.A., D.W., H.S., G.L., D.Z.), Department of Clinical Pharmacology (M.W.), and Center for Medical Physics and Biomedical Engineering and Ludwig-Boltzmann-Cluster for Cardiovascular Research (T.S., H.S.), Medical University of Vienna, Austria; and Division of Adult Cardiothoracic Surgery, University of California, San Francisco School of Medicine (G.W.).
University of California System · USLudwig Boltzmann Institute for Cardiovascular Research · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLeft ventricular assist device-supported patients are usually anticoagulated with a combination of aspirin and vitamin K antagonists. Long-term vitamin K antagonist therapy can be complicated by unstable international normalized ratio values and patient-related compliance problems. Therefore, direct thrombin inhibitors may represent an alternative to vitamin K antagonists. METHODS AND

resultsThirty HeartWare ventricular assist device patients with stable renal function were planned for this prospective, randomized, open-label, single-center study. Patients were randomized to receive either phenprocoumon or dabigatran in addition to aspirin for long-term anticoagulation. Treatment duration was scheduled for 1 year and stopped after observation of a primary end point. Dabigatran dose was 110 and 75 mg BID in patients with normal or impaired renal function (glomerular filtration rate >80 mL/min or between 80 and 30 mL/min, respectively). The study was stopped prematurely for safety reasons after 16 patients (61±8 years, 1 female) were randomized. Thromboembolic events occurred in 4 subjects receiving dabigatran (50%) and in 1 receiving phenprocoumon (13%;

conclusionsThromboembolic events on dabigatran led to early termination of a randomized controlled trial of dabigatran versus phenprocoumon in left ventricular assist device patients. CLINICAL

trial registrationhttps://www.clinicaltrials.gov. Unique identifier: NCT02872649.

Indexed as

AntithrombinsDabigatranDose-Response Relationship, DrugEquipment FailureFemaleFollow-Up StudiesHeart-Assist DevicesHeart VentriclesHumansMaleMiddle AgedPhenprocoumonPilot ProjectsProspective StudiesThromboembolismTime FactorsAntithrombinsDabigatranPhenprocoumonVitamin Kanticoagulantsaspirindabigatranglomerular filtration ratehemorrhage

Identifiers

PMID28500254
PMCPMC5434960
OpenAlexW2612305512

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

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.