Evidence map›Paper›PMID 32079476›Full record

Observational studyJournal of the American Heart Association2020

Impact of Modifiable Bleeding Risk Factors on Major Bleeding in Patients With Atrial Fibrillation Anticoagulated With Rivaroxaban.

Paulus Kirchhof, Sylvia Haas, Pierre Amarenco, Susanne Hess, Marc Lambelet, Martin van Eickels, Alexander G G Turpie, A John Camm, XANTUS Investigators*

Registry-linked trialOpen access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Journal of the American Heart Association, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01606995 (Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation), which is not on this map. 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
4.0field-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.

NCT01606995 completednot on this map

Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation

TypeobservationalSponsorBayerRan2012 to 2015Enrolled6,784ConditionsAtrial FibrillationArmsRivaroxaban (Xarelto, BAY59-7939)
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Brazilian Atrial Fibrillation Guidelines - 2025.Arquivos brasileiros de cardiologia · 2025
    Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Feasibility and safety of same-day discharge and shortened bedrest after atrial fibrillation ablation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2022
    Article
  10. 2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation.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 · 2021
    Article
  11. [Atrial fibrillation].Der Internist · 2021
    Article
  12. Article
  13. Observational
  14. 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

9 authors at 6 institutions in 4 countries.

Paulus KirchhofInstitute of Cardiovascular Sciences UHB and Sandwell & West Birmingham Hospitals NHS Trusts University of Birmingham United Kingdom.
Sylvia HaasFormerly Technical University of Munich Munich Germany.
Pierre AmarencoDepartment of Neurology and Stroke Centre Paris-Diderot-Sorbonne University Paris France.
Susanne HessMedical Affairs Bayer AG Berlin Germany.
Marc LambeletChrestos Concept GmbH & Co KG Essen Germany.
Martin van EickelsMedical Affairs Bayer AG Berlin Germany.
Alexander G G TurpieDepartment of Medicine McMaster University Hamilton Ontario Canada.
A John CammCardiovascular and Cell Sciences Research Institute and Cardiology Clinical Academic Group St George's, University of London London United Kingdom.
XANTUS Investigators*
Bayer (Germany) · DEMcMaster University · CASt George's, University of London · GBTechnical University of Munich · DEUniversité Paris Cité · FRUniversity of Birmingham · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background Reducing major bleeding events is a challenge when managing anticoagulation in patients with atrial fibrillation. This study evaluated the impact of modifiable and nonmodifiable bleeding risk factors in patients with atrial fibrillation receiving rivaroxaban and estimated the impact of risk factor modification on major bleeding events. Methods and Results Modifiable and nonmodifiable risk factors associated with major bleeding events were identified from the XANTUS (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation) prospective registry data set (6784 rivaroxaban-treated patients). Parameters showing univariate association with bleeding were used to construct a multivariable model identifying independent risk factors. Modeling was used to estimate attributed weights to risk factors. Heavy alcohol use (hazard ratio [HR]=2.37; 95% CI 1.24-4.53); uncontrolled hypertension (HR after parameter-wise shrinkage=1.79; 95% CI 1.05-3.05); and concomitant treatment with antiplatelets, nonsteroidal anti-inflammatory drugs, or paracetamol (HR=1.80; 95% CI 1.24-2.61) were identified as modifiable, independent bleeding risk factors. Increasing age (HR=1.25 [per 5-year increment]; 95% CI 1.12-1.38); heart failure (HR=1.97; 95% CI 1.36-2.86); and vascular disease (HR=1.91; 95% CI 1.32-2.77) were identified as nonmodifiable bleeding risk factors. Overall, 128 (1.9%) patients experienced major bleeding events; of these, 11% had no identified bleeding risk factors, 50% had nonmodifiable bleeding risk factors only, and 39% had modifiable bleeding risk factors (with or without nonmodifiable risk factors). The presence of 1 modifiable bleeding risk factor doubled the risk of major bleeding. Conclusions Elimination of modifiable bleeding risk factors is a potentially effective strategy to reduce bleeding risk in atrial fibrillation patients receiving rivaroxaban. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT01606995.

Indexed as

AgedAged, 80 and overAlcohol DrinkingAnti-Inflammatory Agents, Non-SteroidalAtrial FibrillationEuropeFactor Xa InhibitorsFemaleHemorrhageHumansHypertensionMaleMiddle AgedPlatelet Aggregation InhibitorsProspective StudiesRegistriesAnti-Inflammatory Agents, Non-SteroidalFactor Xa InhibitorsPlatelet Aggregation InhibitorsRivaroxabananticoagulationindependent predictormajor bleedingmodeling studymodifiable risk factor

Identifiers

PMID32079476
PMCPMC7335544
OpenAlexW3008358546

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.