Evidence map›Paper›PMID 26888572›Full record

Trial reportHeart (British Cardiac Society)2016

Native valve disease in patients with non-valvular atrial fibrillation on warfarin or rivaroxaban.

Günter Breithardt, Helmut Baumgartner, Scott D Berkowitz, Anne S Hellkamp, Jonathan P Piccini, Yuliya Lokhnygina, Jonathan L Halperin, Daniel E Singer, Graeme J Hankey, Werner Hacke and 7 more

Registry-linked trialOpen access · hybridAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Heart (British Cardiac Society), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00403767 (A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban), which is not on this map. Cited by 17 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 5 pooled it
4.7field-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.

NCT00403767 phase3completednot on this map

A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation

TypeinterventionalSponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.Ran2006 to 2010Enrolled14,269ConditionsAtrial Fibrillation, Stroke, EmbolismArmsRivaroxaban, Warfarin, Matching placebo for Rivaroxaban arm (Warfarin placebo), Matching placebo for Warfarin arm (Rivaroxaban placebo)
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 5 syntheses or guidelines pooled it, 44 citations in OpenAlex.

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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

17 authors at 12 institutions in 4 countries.

Günter BreithardtDivision of Electrophysiology, Department of Cardiovascular Medicine, University Hospital Münster, Münster, Germany.
Helmut BaumgartnerDivision of Adult Congenital and Valvular Heart Disease, Department of Cardiovascular Medicine, University Hospital Münster, Münster, Germany.
Scott D BerkowitzBayer Healthcare Pharmaceuticals, L.P., Whippany, New Jersey, USA.
Anne S HellkampDuke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA.
Jonathan P PicciniDuke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA.
Yuliya LokhnyginaDuke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA.
Jonathan L HalperinThe Cardiovascular Institute, Mount Sinai Medical Center, New York, USA.
Daniel E SingerClinical Epidemiology Unit, Division of General Internal Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts, USA.
Graeme J HankeySchool of Medicine and Pharmacology, The University of Western Australia, Perth, Australia.
Werner HackeRuprecht-Karls-University, Heidelberg, Germany.
Richard C BeckerDivision of Cardiovascular Health and Disease, Department of Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
Christopher C NesselJohnson & Johnson Pharmaceutical Research & Development, Raritan, New Jersey, USA.
Kenneth W MahaffeyDepartment of Medicine, Stanford University, Stanford, California, USA.
Robert M CaliffDuke Translational Medicine Institute, Duke University Medical Center, Durham, North Carolina, USA.
Keith A A FoxUniversity of Edinburgh, and Royal Infirmary of Edinburgh, Edinburgh, UK.
Manesh R PatelDuke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA.
ROCKET AF Steering Committee & Investigators
Clinical Research Institute · USDuke Medical Center · USUniversity Hospital Münster · DEBayer (United States) · USCardiovascular Institute of the South · USEdinburgh Royal Infirmary · GBHeidelberg University · DEJohnson & Johnson (United States) · USMassachusetts General Hospital · USStanford University · USUniversity of Cincinnati Medical Center · USUniversity of Western Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo compare the characteristics and outcomes of patients with atrial fibrillation (AF) and aortic stenosis (AS) with patients with AF with mitral regurgitation (MR) or aortic regurgitation (AR) and patients without significant valve disease (no SVD).

methodsUsing 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) data, we analysed efficacy and safety outcomes, adjusting hazard ratios (HRs) for potential confounders using Cox regression analysis.

resultsAmong 14 119 intention-to-treat ROCKET AF trial patients, a trial that excluded patients with mitral stenosis or artificial valve prosthesis, 214 had AS with or without other valve abnormalities, 1726 had MR or AR and 12 179 had no SVD. After adjusting for prognostic factors, the composite of stroke, systemic embolism or vascular death increased approximately twofold in patients with AS (AS 10.84, MR or AR 4.54 and no SVD 4.31 events per 100 patient-years, p=0.0001). All-cause death also significantly increased (AS 11.22, MR or AR 4.90 and no SVD 4.39 events per 100 patient-years, p=0.0003). Major bleeding occurred more frequently in AS (adjusted HR 1.61, confidence intervals (CI) 1.03 to 2.49, p<0.05) and MR or AR (HR 1.30, 1.07 to 1.57, p<0.01) than in no SVD, but there was no difference between AS and MR or AR (HR 1.24, 0.78 to 1.97). The relative efficacy of rivaroxaban versus warfarin was consistent among patients with and without valvular disease. Rivaroxaban was associated with higher rates of major bleeding than warfarin in patients with MR or AR (HR 1.63, 1.15 to 2.31).

conclusionsWe found that patients with AF and AS on oral anticoagulants may have distinctly different efficacy and safety outcomes than patients with MR or AR or no SVD. TRIAL REGISTRATION NUMBER: NCT00403767; Post-results.

Indexed as

Administration, OralAgedAged, 80 and overAnticoagulantsAortic Valve InsufficiencyAortic Valve StenosisAtrial FibrillationDrug Administration ScheduleFemaleHumansMaleMitral Valve InsufficiencyRetrospective StudiesRivaroxabanStrokeTreatment OutcomeAnticoagulantsRivaroxabanWarfarin

Identifiers

PMID26888572
PMCPMC4941167
OpenAlexW2274286352

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.