Evidence map›Paper›PMID 33011964›Full record

Trial reportThrombosis and haemostasis2021

Long-Term Treatment with Apixaban in Patients with Atrial Fibrillation: Outcomes during the Open-Label Extension following AVERROES.

Alexander P Benz, John W Eikelboom, Salim Yusuf, Stefan H Hohnloser, Anja Kahl, Heather Beresh, Kumar Balasubramanian, Jeff S Healey, Stuart J Connolly

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Thrombosis and haemostasis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.3field-weighted citation impact, top 17% 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

2 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Atrial fibrillation and stroke prevention: 25 years of research at EP Europace journal.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 · 2023
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 3 countries.

Alexander P BenzPopulation Health Research Institute, Hamilton, Ontario, Canada.ORCID 0000-0003-2555-1266
John W EikelboomPopulation Health Research Institute, Hamilton, Ontario, Canada.
Salim YusufPopulation Health Research Institute, Hamilton, Ontario, Canada.
Stefan H HohnloserDivision Clinical Electrophysiology, Department of Cardiology, Johann Wolfgang Goethe University, Frankfurt, Germany.
Anja KahlBristol-Myers Squibb, Lawrenceville, New Jersey, Unites States.
Heather BereshPopulation Health Research Institute, Hamilton, Ontario, Canada.
Kumar BalasubramanianPopulation Health Research Institute, Hamilton, Ontario, Canada.
Jeff S HealeyPopulation Health Research Institute, Hamilton, Ontario, Canada.
Stuart J ConnollyPopulation Health Research Institute, Hamilton, Ontario, Canada.
Population Health Research Institute · CABristol-Myers Squibb (United States) · USGoethe University Frankfurt · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAVERROES, a randomized controlled trial in high-risk patients with atrial fibrillation, unsuitable for vitamin K antagonist therapy, demonstrated efficacy and safety of apixaban compared with aspirin. At the conclusion of the double-blind phase, an open-label extension was initiated to allow study participants to receive apixaban until it became locally available. This study reports outcomes of patients on apixaban during the open-label extension.

methodsRates of stroke or systemic embolism, hemorrhagic stroke, major bleeding, and other outcomes during the open-label extension are reported.

resultsOf the 5,599 participants enrolled in AVERROES, 3,275 (58.5%) received apixaban during the open-label extension. Median (interquartile range) follow-up in the open-label extension was 3.0 (2.5-3.5) years. The rate of stroke or systemic embolism during the open-label extension was 1.0% per year, and the annual rates of hemorrhagic stroke and major bleeding were 0.3 and 1.2%, respectively. After adjustment for imbalances in patient variables, event rates in patients on apixaban during the open-label extension were similar to those of patients receiving apixaban during AVERROES. Additional analyses in all patients who received apixaban, at any time from the start of AVERROES to the end of the open-label extension, were performed. This cohort (

conclusionDuring the open-label extension, annual rates of stroke or systemic embolism, hemorrhagic stroke, and major bleeding remained as low as those observed during apixaban treatment in AVERROES. These data support the long-term efficacy and safety of apixaban in patients with atrial fibrillation.

Indexed as

AgedAged, 80 and overAtrial FibrillationDouble-Blind MethodEmbolismFactor Xa InhibitorsFemaleHemorrhageHemorrhagic StrokeHumansIschemic StrokeMaleMiddle AgedPyrazolesPyridonesRisk AssessmentapixabanFactor Xa InhibitorsPyrazolesPyridones

Identifiers

PMID33011964
PMCPMC7982299
OpenAlexW3090611917

What OpenQuestion holds

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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.