Evidence map›Paper›PMID 29659797›Full record

Trial reportEuropean heart journal2018

Apixaban compared to heparin/vitamin K antagonist in patients with atrial fibrillation scheduled for cardioversion: the EMANATE trial.

Michael D Ezekowitz, Charles V Pollack, Jonathan L Halperin, Richard D England, Sandra VanPelt Nguyen, Judith Spahr, Maria Sudworth, Nilo B Cater, Andrei Breazna, Jonas Oldgren and 1 more

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European heart journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02100228 (A Phase Iv Trial To Assess The Effectiveness Of Apixaban Compared With Usual Care Anticoagulation In Subjects With Non-valvular Atrial Fibrillation Undergoing Cardioversion), which is not on this map. Cited by 75 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 10 pooled it
–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.

NCT02100228 phase4completednot on this map

A Phase Iv Trial To Assess The Effectiveness Of Apixaban Compared With Usual Care Anticoagulation In Subjects With Non-valvular Atrial Fibrillation Undergoing Cardioversion

TypeinterventionalSponsorPfizerRan2014 to 2017Enrolled1,500ConditionsAtrial FibrillationArmsApixaban, Parenteral heparin and/or oral Vitamin K antagonist
3 · Its place in the literature

Who cites it

75 citing papers in PubMed, 10 syntheses or guidelines pooled it.

  1. Guideline
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Trial
  12. Article
  13. Observational
  14. Review
  15. Perioperative atrial fibrillation after non-cardiac surgery - A narrative review.Clinical research in cardiology : official journal of the German Cardiac Society · 2026
    Review
  16. How much does elective cardioversion increase the risk of ischaemic stroke compared to the baseline risk in atrial fibrillation? A nationwide study.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 · 2025
    Article
  17. Article
  18. Review
  19. Article
  20. Article

15 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Michael D EzekowitzSidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.
Charles V PollackThomas Jefferson University, Philadelphia, PA, USA.
Jonathan L HalperinIcahn School of Medicine, New York, NY, USA.
Richard D EnglandPfizer, Groton, CT, USA.
Sandra VanPelt NguyenPfizer, Groton, CT, USA.
Judith SpahrThomas Jefferson University, Philadelphia, PA, USA.
Maria SudworthPfizer, London, UK.
Nilo B CaterPfizer, New York, NY, USA.
Andrei BreaznaPfizer, New York, NY, USA.
Jonas OldgrenUppsala Clinical Research Centre and Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
Paulus KirchhofUniversity of Birmingham Institute of Cardiovascular Sciences, SWBH and UHB NHS Trusts, Birmingham, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Aim: The primary objective was to compare apixaban to heparin/vitamin K antagonist (VKA) in patients with atrial fibrillation (AF) and ≤48 h anticoagulation prior to randomization undergoing cardioversion. Methods: One thousand five hundred patients were randomized. The apixaban dose of 5 mg b.i.d. was reduced to 2.5 mg b.i.d. in patients with two of the following: age ≥ 80 years, weight ≤ 60 kg, or serum creatinine ≥ 133 µmol/L. To expedite cardioversion, at the discretion of the investigator, imaging and/or a loading dose of 10 mg (down-titrated to 5 mg) was allowed. The endpoints for efficacy were stroke, systemic embolism (SE), and death. The endpoints for safety were major bleeding and clinically relevant non-major (CRNM) bleeding. Results: There were 1038 active and 300 spontaneous cardioversions; 162 patients were not cardioverted. Imaging was performed in 855 patients, and 342 received a loading dose of apixaban. Comparing apixaban to heparin/VKA in the full analysis set, there were 0/753 vs. 6/747 strokes [relative risk (RR) 0; 95% confidence interval (95% CI) 0-0.64; nominal P = 0.015], no SE, and 2 vs. 1 deaths (RR 1.98; 95% CI 0.19-54.00; nominal P > 0.999). In the safety population, there were 3/735 vs. 6/721 major (RR 0.49; 95% CI 0.10-2.07; nominal P = 0.338) and 11 vs. 13 CRNM bleeding events (RR 0.83; 95% CI 0.34-1.89; nominal P = 0.685). On imaging, 60/61 with thrombi continued randomized treatment; all (61) were without outcome events. Conclusions: Rates of strokes, systemic emboli, deaths, and bleeds were low for both apixaban and heparin/VKA treated AF patients undergoing cardioversion. Clinical Trials.gov number: NCT02100228.

Indexed as

Electric CountershockAgedAnticoagulantsAtrial FibrillationCause of DeathDrug Administration ScheduleEchocardiography, TransesophagealEmbolismFemaleHemorrhageHeparinHumansMaleMiddle AgedPyrazolesPyridonesAnticoagulantsapixabanHeparinPyrazolesPyridonesVitamin K

Identifiers

PMID29659797
PMCPMC6110194

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.