Evidence map›Paper›PMID 26330425›Full record

Observational studyEuropean heart journal2016

XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation.

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

Erratum issued 2 registry-linked trialsAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in European heart journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 148 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
148citing papers in PubMed, 4 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.

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)
NCT04315974 unknown statusnot on this mapstarted 2020, after this paper: background citation

Italian Registry In the Setting of AF Ablation With Rivaroxaban

Typeobservational_patient_registrySponsorDr Carlo LavalleRan2020 to 2022Enrolled250ConditionsAtrial FibrillationArmsRivaroxaban, Catheter ablation
3 · Its place in the literature

Who cites it

148 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Pooled it
  5. Anticoagulation, therapy of concomitant conditions, and early rhythm control therapy: a detailed analysis of treatment patterns in the EAST - AFNET 4 trial.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
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  12. Pulsed field ablation: focused on atrial fibrillation ablation.The Korean journal of internal medicine · 2026
    Review
  13. Article
  14. Observational
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  20. Observational

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

A John CammCardiovascular and Cell Sciences Research Institute, St George's, University of London, Cranmer Terrace, SW170RE London, UK jcamm@sgul.ac.uk.
Pierre AmarencoDepartment of Neurology and Stroke Center, Paris-Diderot-Sorbonne University, Paris, France.
Sylvia HaasVascular Center, Munich, Germany.
Susanne HessGlobal Medical Affairs, Bayer HealthCare Pharmaceuticals, Berlin, Germany.
Paulus KirchhofCentre for Cardiovascular Sciences, University of Birmingham and Sandwell & West Birmingham Hospitals NHS Trust, Birmingham, UK Department of Cardiovascular Medicine, University of Münster, Münster, Germany.
Silvia KuhlsGlobal Integrated Analysis, Bayer HealthCare Pharmaceuticals, Wuppertal, Germany.
Martin van EickelsGlobal Medical Affairs, Bayer HealthCare Pharmaceuticals, Berlin, Germany.
Alexander G G TurpieDepartment of Medicine, McMaster University, Hamilton, ON, Canada.
XANTUS Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsAlthough non-vitamin K antagonist oral anticoagulants are recommended for stroke prevention in patients with non-valvular atrial fibrillation (NVAF) based on clinical trial results, there is a need for safety and efficacy data from unselected patients in everyday clinical practice. XANTUS investigated the safety and efficacy of the Factor Xa inhibitor rivaroxaban in routine clinical use in the NVAF setting. METHODS AND

resultsConsecutive consenting patients with NVAF newly started on rivaroxaban were eligible and were followed up at ∼3-month intervals for 1 year, or for at least 30 days after permanent discontinuation. All adverse events (AEs) were recorded as AEs or serious AEs; major outcomes (including major bleeding, symptomatic thromboembolic events [stroke, systemic embolism, transient ischaemic attack, and myocardial infarction], and all-cause death) were centrally adjudicated. There were 6784 patients treated with rivaroxaban at 311 centres in Europe, Israel, and Canada. Mean patient age was 71.5 years (range 19-99), 41% were female, and 9.4% had documented severe or moderate renal impairment (creatinine clearance <50 mL/min). The mean CHADS2 and CHA2DS2-VASc scores were 2.0 and 3.4, respectively; 859 (12.7%) patients had a CHA2DS2-VASc score of 0 or 1. The mean treatment duration was 329 days. Treatment-emergent major bleeding occurred in 128 patients (2.1 events per 100 patient-years), 118 (1.9 events per 100 patient-years) died, and 43 (0.7 events per 100 patient-years) suffered a stroke.

conclusionXANTUS is the first international, prospective, observational study to describe the use of rivaroxaban in a broad NVAF patient population. Rates of stroke and major bleeding were low in patients receiving rivaroxaban in routine clinical practice. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov: NCT01606995.

Indexed as

AdultAgedAnticoagulantsAtrial FibrillationFactor Xa InhibitorsFemaleHumansMaleMiddle AgedProspective StudiesRivaroxabanStrokeYoung AdultAnticoagulantsFactor Xa InhibitorsRivaroxabanAnticoagulantsAtrial fibrillationReal worldRivaroxabanStrokeThromboembolism

Identifiers

PMID26330425
PMCPMC4823634

What OpenQuestion holds

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LicenceCC BY-NC
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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.