Evidence map›Paper›PMID 29947751›Full record

Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2018

Edoxaban therapy increases treatment satisfaction and reduces utilization of healthcare resources: an analysis from the EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of atrial fibrillation (ENSURE-AF) study.

Andreas Goette, Winghan J Kwong, Michael D Ezekowitz, Maciej Banach, Soren P Hjortshoj, Dmitry Zamoryakhin, Gregory Y H Lip

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in 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, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02072434 (A Prospective, Randomized, Open-Label Blinded Endpoint Evaluation), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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.

NCT02072434 phase3completednot on this map

A Prospective, Randomized, Open-Label Blinded Endpoint Evaluation (PROBE) Parallel Group Study Comparing Edoxaban (DU-176b) With Enoxaparin/Warfarin Followed by Warfarin Alone in Subjects Undergoing Planned Electrical Cardioversion of Nonvalvular Atrial Fibrillation

TypeinterventionalSponsorDaiichi SankyoRan2014 to 2016Enrolled2,199ConditionsAtrial FibrillationArmsEdoxaban, Warfarin, Enoxaparin
3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Trial
  2. Health-related quality of life and healthcare costs of symptoms and cardiovascular disease events in patients with atrial fibrillation: a longitudinal analysis of 27 countries from the EURObservational Research Programme on Atrial Fibrillation general long-term registry.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 · 2024
    Observational
  3. Review
  4. Observational
  5. Article
  6. 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
  7. Cardioversion of atrial fibrillation and atrial flutter revisited: current evidence and practical guidance for a common procedure.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 · 2020
    Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Impact of Edoxaban on Thrombin-Dependent Platelet Aggregation.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    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

7 authors.

Andreas GoetteSt. Vincenz-Hospital Paderborn, Am Busdorf 2, Paderborn, Germany.
Winghan J KwongDaiichi Sankyo, Inc., Basking Ridge, NJ, USA.
Michael D EzekowitzSidney Kimmel Jefferson Medical College at Thomas Jefferson University and Lankenau Medical Center, Broomall, PA, USA.
Maciej BanachMedical University of Lodz, Lodz, Poland.
Soren P HjortshojDepartment of Clinical Medicine, Aalborg University Hospital, Aalborg, Denmark.
Dmitry ZamoryakhinDaiichi Sankyo Development, Ltd, Gerrards Cross, UK.
Gregory Y H LipInstitute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Aims: The EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of atrial fibrillation (ENSURE-AF) (NCT02072434) study was a multicentre prospective, randomized, open-label, blinded-endpoint evaluation (PROBE) trial comparing edoxaban with enoxaparin/warfarin followed by warfarin alone in 2199 non-valvular atrial fibrillation patients undergoing electrical cardioversion and showed comparable rates of bleeding and thromboembolism between treatments. This prespecified ancillary analysis investigated the impact of edoxaban therapy on treatment satisfaction and utilization of healthcare services. Methods and results: The Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) was completed by study patients on Day 28 post-cardioversion. Higher scores represent greater satisfaction. Healthcare resource utilizations were collected from randomization to Day 28 post-cardioversion. Data from patients who received at least one dose of study drugs were analysed. Patients treated with edoxaban were more satisfied than enoxaparin/warfarin in both PACT-Q treatment satisfaction and convenience scores (P < 0.001 for both). Differences in treatment satisfaction scores were greater in patients who underwent non-transoesophageal echocardiography (TOE)-guided cardioversion than in patients who underwent TOE-guided cardioversion. Edoxaban was associated with fewer clinic visits (4.75 visits vs. 7.60 visits; P < 0.001) and fewer hospital days (3.43 days vs. 5.41 days; P < 0.05). Rates of hospitalizations and emergency room visits were not significantly different. Overall, edoxaban therapy was estimated to reduce healthcare costs by €107.73, €437.92, €336.75, and $246.32 per patient in German, Spanish, Italian, and US settings, respectively. Conclusions: The convenience of edoxaban therapy over warfarin in patients undergoing cardioversion may provide greater treatment satisfaction and cost savings to the healthcare system.

Indexed as

Electric CountershockPatient SatisfactionAgedAnticoagulantsAtrial FibrillationCost-Benefit AnalysisCost SavingsDrug CostsEchocardiography, TransesophagealEmergency Service, HospitalEuropeFactor Xa InhibitorsFemaleHemorrhageHospital CostsHumansAnticoagulantsedoxabanFactor Xa InhibitorsPyridinesThiazolesWarfarin

Identifiers

PMID29947751
PMCPMC6275467

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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.