Evidence map›Paper›PMID 25148838›Full record

Trial reportEuropean heart journal2014

Clinical characteristics and outcomes with rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation but underlying native mitral and aortic valve disease participating in the ROCKET AF trial.

Günter Breithardt, Helmut Baumgartner, Scott D Berkowitz, Anne S Hellkamp, Jonathan P Piccini, Susanna R Stevens, Yuliya Lokhnygina, Manesh R Patel, Jonathan L Halperin, Daniel E Singer and 8 more

Open access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European heart journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 11 pooled it
14.6field-weighted citation impact, top 1% 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

66 citing papers in PubMed, 11 syntheses or guidelines pooled it, 199 citations in OpenAlex.

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  15. Brazilian Atrial Fibrillation Guidelines - 2025.Arquivos brasileiros de cardiologia · 2025
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6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 11 institutions in 5 countries.

Günter BreithardtDepartment of Cardiovascular Medicine, Division of Electrophysiology, University Hospital Münster, Von-Esmarch-Strasse 117, Münster D-48149, Germany g.breithardt@uni-muenster.de.
Helmut BaumgartnerDepartment of Cardiovascular Medicine, Division of Adult Congenital and Valvular Heart Disease, University Hospital Münster, Münster, Germany.
Scott D BerkowitzBayer Healthcare Pharmaceuticals, L.P., Whippany, NJ, USA.
Anne S HellkampDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Jonathan P PicciniDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Susanna R StevensDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Yuliya LokhnyginaDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Manesh R PatelDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Jonathan L HalperinThe Cardiovascular Institute, Mount Sinai Medical Center, New York, NY, USA.
Daniel E SingerClinical Epidemiology Unit, General Medicine Division, Massachusetts General Hospital, and Harvard Medical School, Boston, MA, USA.
Graeme J HankeySchool of Medicine and Pharmacology, The University of Western Australia, Perth, Australia.
Werner HackeRuprecht-Karls-University, Heidelberg, Germany.
Richard C BeckerDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Christopher C NesselJohnson & Johnson Pharmaceutical Research & Development, Raritan, NJ, USA.
Kenneth W MahaffeyDepartment of Medicine, Stanford University, Stanford, CA, USA.
Keith A A FoxUniversity of Edinburgh, and Royal Infirmary of Edinburgh, Edinburgh, UK.
Robert M CaliffDuke Translational Medicine Institute, Duke University Medical Center, Durham, NC, USA.
ROCKET AF Steering Committee & Investigators
Duke Medical Center · USClinical Research Institute · USUniversity Hospital Münster · DEBayer (United States) · USHarvard University · USHeidelberg University · DEJohnson & Johnson (United States) · USMount Sinai Medical Center · USStanford University · USUniversity of Edinburgh · GBUniversity of Western Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsWe investigated clinical characteristics and outcomes of patients with significant valvular disease (SVD) in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) trial. METHODS AND

resultsROCKET AF excluded patients with mitral stenosis or artificial valve prostheses. We used Cox regression to adjust comparisons for potential confounders. Among 14 171 patients, 2003 (14.1%) had SVD; they were older and had more comorbidities than patients without SVD. The rate of stroke or systemic embolism with rivaroxaban vs. warfarin was consistent among patients with SVD [2.01 vs. 2.43%; hazard ratio (HR) 0.83, 95% confidence interval (CI) 0.55-1.27] and without SVD (1.96 vs. 2.22%; HR 0.89, 95% CI 0.75-1.07; interaction P = 0.76). However, rates of major and non-major clinically relevant bleeding with rivaroxaban vs. warfarin were higher in patients with SVD (19.8% rivaroxaban vs. 16.8% warfarin; HR 1.25, 95% CI 1.05-1.49) vs. those without (14.2% rivaroxaban vs. 14.1% warfarin; HR 1.01, 95% CI 0.94-1.10; interaction P = 0.034), even when controlling for risk factors and potential confounders. In intracranial haemorrhage, there was no interaction between patients with and without SVD where the overall rate was lower among those randomized to rivaroxaban.

conclusionsMany patients with 'non-valvular atrial fibrillation' have significant valve lesions. Their risk of stroke is similar to that of patients without SVD after controlling for stroke risk factors. Efficacy of rivaroxaban vs. warfarin was similar in patients with and without SVD; however, the observed risk of bleeding was higher with rivaroxaban in patients with SVD but was the same among those without SVD. Atrial fibrillation patients with and without SVD experience the same stroke-preventive benefit of oral anticoagulants.

Indexed as

AgedAnticoagulantsAortic Valve InsufficiencyAtrial FibrillationFactor Xa InhibitorsFemaleHemorrhageHumansMaleMitral Valve InsufficiencyMorpholinesRivaroxabanStrokeThiophenesTreatment OutcomeWarfarinAnticoagulantsFactor Xa InhibitorsMorpholinesRivaroxabanThiophenesWarfarinAnticoagulantsFibrillationHeart diseasesRegurgitationStenosis

Identifiers

PMID25148838
PMCPMC4265383
OpenAlexW2113470320

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.