Evidence map›Paper›PMID 26892845›Full record

Trial reportDrugs in R&D2016

Dabigatran Versus Warfarin After Bioprosthesis Valve Replacement for the Management of Atrial Fibrillation Postoperatively: DAWA Pilot Study.

André Rodrigues Durães, Pollianna de Souza Roriz, Bianca de Almeida Nunes, Felipe Pinho E Albuquerque, Fábio Vieira de Bulhões, Andre Mauricio de Souza Fernandes, Roque Aras

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Drugs in R&D, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 43 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 13 pooled it
5.8field-weighted citation impact, top 3% 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.

NCT01868243 phase2 / phase3terminatednot on this map

Dabigatran Versus Warfarin After Mitral and Aortic Bioprosthesis Replacement for the Management of Atrial Fibrillation Postoperatively: Pilot Study

TypeinterventionalSponsorHospital Ana NeryRan2013 to 2014Enrolled27ConditionsPrimary DiseaseArmsDabigatran, Warfarin
NCT02894307 no longer availablenot on this map

Evaluation of Thromboembolic Events in Patients With Bileaflet Mechanical Valves in Mitral Position Before and After Rivaroxaban Use: RMV Study

Typeexpanded_accessSponsorHospital Ana NeryConditionsProsthesis, Cardiac, Heart, Functional Disturbance as ResultArmsRivaroxaban
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 13 syntheses or guidelines pooled it, 111 citations in OpenAlex.

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  12. Comparing the Direct Oral Anticoagulants versus Vitamin K Antagonists in Bioprosthetic Valves: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
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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

7 authors at 1 institution in 1 country.

André Rodrigues DurãesHospital Ana Nery/UFBa, Rua Saldanha Marinho, S/N, Caixa D´Agua, Salvador, Brazil. andreduraes@gmail.com.
Pollianna de Souza RorizHospital Ana Nery/UFBa, Rua Saldanha Marinho, S/N, Caixa D´Agua, Salvador, Brazil.
Bianca de Almeida NunesHospital Ana Nery/UFBa, Rua Saldanha Marinho, S/N, Caixa D´Agua, Salvador, Brazil.
Felipe Pinho E AlbuquerqueHospital Ana Nery/UFBa, Rua Saldanha Marinho, S/N, Caixa D´Agua, Salvador, Brazil.
Fábio Vieira de BulhõesHospital Ana Nery/UFBa, Rua Saldanha Marinho, S/N, Caixa D´Agua, Salvador, Brazil.
Andre Mauricio de Souza FernandesHospital Ana Nery/UFBa, Rua Saldanha Marinho, S/N, Caixa D´Agua, Salvador, Brazil.
Roque ArasHospital Ana Nery/UFBa, Rua Saldanha Marinho, S/N, Caixa D´Agua, Salvador, Brazil.
Hospital Ana Nery · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesDabigatran is a direct thrombin inhibitor shown to be an effective alternative to warfarin in patients with non-valvular atrial fibrillation (AF). We evaluated the use of dabigatran in patients with bioprosthetic mitral and/or aortic valve replacement and AF.

methodsWe selected 34 and randomized 27 patients in a 1:1 ratio to receive dabigatran or warfarin. The primary endpoint was the presence of a new intracardiac thrombus at 90 days, by transesophageal echocardiogram (TEE). Secondary endpoints included the development of dense spontaneous echo contrast (SEC) and incidence of stroke (ischemic or hemorrhagic), myocardium infarction, valve thrombosis and peripheral embolic events.

resultsThe trial was terminated prematurely because of low enrollment. There were 27 patients in total: 15 patients placed in the dabigatran group and 12 in the warfarin group. After 90 days, one patient (8.3 %) in the warfarin group and none in the dabigatran group had developed a new intracardiac thrombus. In the dabigatran group, two patients (13.3 %) developed dense SEC versus one patient (8.3 %) in the warfarin group. In the warfarin group, one patient (8.3 %) presented ischemic stroke, and none did in the dabigatran group. We observed no cases of hemorrhagic stroke, valve thrombosis, embolic events or myocardial infarction in either group throughout the study. However, one patient (6.7 %) in the dabigatran group had a fully recovered transient ischemic attack and one patient in the warfarin group died of heart failure.

conclusionsThe use of dabigatran appears to be similar to warfarin in preventing the formation of intracardiac thrombus.

trial registrationClinicaltrials.gov NCT01868243.

Indexed as

AdolescentAdultAntithrombinsAtrial FibrillationBioprosthesisCardiac Valve AnnuloplastyDabigatranFemaleHeart DiseasesHumansMaleMiddle AgedPilot ProjectsThrombosisTreatment OutcomeWarfarinAntithrombinsDabigatranWarfarin

Identifiers

PMID26892845
PMCPMC4875919
OpenAlexW2283535237

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.