Evidence map›Paper›PMID 32860041›Full record

Trial reportEuropean heart journal2020

Edoxaban in atrial fibrillation patients with percutaneous coronary intervention by acute or chronic coronary syndrome presentation: a pre-specified analysis of the ENTRUST-AF PCI trial.

Pascal Vranckx, Marco Valgimigli, Lars Eckardt, Thorsten Lewalter, Ramunas Unikas, Francisco Marin, François Schiele, Petra Laeis, Paul-Egbert Reimitz, Rüdiger Smolnik and 3 more

Erratum issuedOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European heart journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 5% 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.

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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Clinical risk predictors in atrial fibrillation patients following successful coronary stenting: ENTRUST-AF PCI sub-analysis.Clinical research in cardiology : official journal of the German Cardiac Society · 2021
    Trial
  3. Review
  4. Article
  5. Review
  6. Review
  7. Observational
  8. Article
  9. Review
  10. 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
  11. Therapeutic uncertainties: first finding of atrial fibrillation in acute coronary syndrome.European heart journal supplements : journal of the European Society of Cardiology · 2022
    Article
  12. Article
  13. Article
  14. Ten years of non-vitamin K antagonists oral anticoagulants for stroke prevention in atrial fibrillation: is warfarin obsolete?European heart journal supplements : journal of the European Society of Cardiology · 2020
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 6 countries.

Pascal VranckxDepartment of Cardiology & Critical Care Jessaziekenhuis Hasselt, Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium.
Marco ValgimigliDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Lars EckardtAtrial Fibrillation Network (AFNET), Münster, Germany.
Thorsten LewalterAtrial Fibrillation Network (AFNET), Münster, Germany.
Ramunas UnikasUniversity of Health Sciences hospital, Kaunas, Lithuanian, Lithuania.
Francisco MarinHospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, CIBERCV, Murcia, Spain.
François SchieleChru Jean Minjoz, Besancon, France.
Petra LaeisDaiichi Sankyo Europe GmbH, München, Germany.
Paul-Egbert ReimitzDaiichi Sankyo Europe GmbH, München, Germany.
Rüdiger SmolnikDaiichi Sankyo Europe GmbH, München, Germany.
Wolfgang ZierhutDaiichi Sankyo Europe GmbH, München, Germany.
Jan TijssenDepartment of Cardiology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.
Andreas GoetteAtrial Fibrillation Network (AFNET), Münster, Germany.
Daiichi Sankyo (Germany) · DEAmsterdam University Medical Centers · NLAtrial Fibrillation NETwork · DECentre Hospitalier Universitaire de Besançon · FRCentro de Investigación en Red en Enfermedades Cardiovasculares · ESHasselt University · BEUniversity of Bern · CHUniversity of Bonn · DEUniversity of Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo compare the safety and efficacy of edoxaban combined with P2Y12 inhibition following percutaneous coronary intervention (PCI) in patients with atrial fibrillation (AF) presenting with an acute coronary syndrome (ACS) or chronic coronary syndrome (CCS). METHODS AND

resultsIn this pre-specified sub-analysis of the ENTRUST-AF PCI trial, participants were randomly assigned 1:1 to edoxaban- or vitamin K antagonist (VKA)-based strategy and randomization was stratified by ACS (edoxaban n = 388, VKA n = 389) vs. CCS (edoxaban n = 363, VKA = 366). Participants received edoxaban 60 mg once-daily plus a P2Y12 inhibitor for 12 months, or VKA combined with a P2Y12 inhibitor and aspirin 100 mg (for 1-12 months). The primary bleeding endpoint at 12 months occurred in 59 (15.2%) vs. 79 (20.3%) ACS patients [hazard ratio (HR): 0.73, 95% confidence interval (CI): 0.59-1.02, P = 0.063], and in 69 (19.0%) vs. 73 (19.9%) CCS patients (HR: 0.94, 95%CI: 0.68-1.31, P = 0.708) with edoxaban- and VKA-based therapy, respectively [P for interaction (P-int) = 0.2741]. The main secondary endpoint (composite of CV death, myocardial infarction, stroke, systemic embolic events, or definite stent thrombosis) in ACS patients was 33 (8.5%) vs. 28 (7.2%) (HR: 1.16, 95%CI: 0.70-1.92), compared with 16 (4.4%) vs. 18 (4.9%) (HR: 0.91, 95%CI: 0.47-1.78) CCS patients with edoxaban and VKA-based therapy, respectively (P-int = 0.5573).

conclusionsIn patients with AF who underwent PCI, the edoxaban-based regimen, as compared with VKA-based regimen, provides consistent safety and similar efficacy for ischaemic events in patients with AF regardless of their clinical presentation.

Indexed as

Acute Coronary SyndromeAtrial FibrillationPercutaneous Coronary InterventionStrokeAnticoagulantsFibrinolytic AgentsHumansPlatelet Aggregation InhibitorsPyridinesThiazolesTreatment OutcomeAnticoagulantsedoxabanFibrinolytic AgentsPlatelet Aggregation InhibitorsPyridinesThiazolesAcute coronary syndromesAnticoagulationAtrial fibrillationEdoxabanPercutaneous coronary interventionStable coronary artery disease

Identifiers

PMID32860041
PMCPMC7767635
OpenAlexW3082341997

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.