Evidence map›Paper›PMID 32562206›Full record

Trial reportDrugs2020

Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention in Patients with Atrial Fibrillation With/Without a Proton Pump Inhibitor: A Pre-Specified Analysis of the RE-DUAL PCI Trial.

José C Nicolau, Deepak L Bhatt, Stefan H Hohnloser, Takeshi Kimura, Gregory Y H Lip, Corinna Miede, Matias Nordaby, Jonas Oldgren, Philippe Gabriel Steg, Jurriën M Ten Berg and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical TrialComparative StudyMulticenter Study
In one paragraph

Trial report in Drugs, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02164864 (A Prospective Randomised, Open Label, Blinded Endpoint), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 15% 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.

NCT02164864 phase3completednot on this map

A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus Clopidogrel or Ticagrelor and Aspirin in Patients With Non Valvular Atrial Fibrillation (NVAF) That Have Undergone a Percutaneous Coronary Intervention (PCI) With Stenting

TypeinterventionalSponsorBoehringer IngelheimRan2014 to 2017Enrolled2,725ConditionsAtrial Fibrillation, Percutaneous Coronary InterventionArmsDabigatran Etexilate 110mg, Warfarin 3mg, Aspirin, Dabigatran Etexilate 150mg, Clopidogrel or Ticagrelor
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. 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

13 authors at 11 institutions in 10 countries.

José C NicolauInstituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Enéas Carvalho Aguiar, 44, Sao Paulo, SP, 05403-000, Brazil. jose.nicolau@incor.usp.br.ORCID http://orcid.org/0000-0002-9680-3689
Deepak L BhattBrigham and Women's Hospital and Heart and Vascular Center, and Harvard Medical School, Boston, MA, USA.
Stefan H HohnloserJohann Wolfgang Goethe University, Frankfurt am Main, Germany.
Takeshi KimuraKyoto University, Kyoto, Japan.
Gregory Y H LipLiverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, UK.
Corinna MiedeMainanalytics ma GmbH, Sulzbach (Taunus), Germany.
Matias NordabyBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Jonas OldgrenUppsala Clinical Research Center, and Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
Philippe Gabriel StegUniversité de Paris, FACT, INSERM U_1148, Paris, France.
Jurriën M Ten BergSt. Antonius Ziekenhuis, Nieuwegein, the Netherlands.
Lucas C GodoyInstituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Enéas Carvalho Aguiar, 44, Sao Paulo, SP, 05403-000, Brazil.
Christopher P CannonBrigham and Women's Hospital and Heart and Vascular Center, and Harvard Medical School, Boston, MA, USA.
RE-DUAL PCI Steering Committee and Investigators
Brigham and Women's Hospital · USBoehringer Ingelheim (Germany) · DEGoethe University Frankfurt · DEHospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BRInserm · FRKyoto University · JPReference Institute for Bioanalytics · DESt. Antonius Ziekenhuis · NLUniversity of Liverpool · GBUniversity of Toronto · CAUppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveIn patients with atrial fibrillation following percutaneous coronary intervention, if a proton pump inhibitor is used, could that allow the use of warfarin triple therapy, or is there additional reduction in bleeding while using it with dual therapy?

methodsThe RE-DUAL PCI trial randomized 2725 patients with atrial fibrillation post-percutaneous coronary intervention to dabigatran dual therapy (110 or 150 mg twice daily, with clopidogrel or ticagrelor) or warfarin triple therapy (with clopidogrel or ticagrelor, and aspirin for 1-3 months). This prespecified subgroup analysis evaluated risks of a first major bleeding event or clinically relevant non-major bleeding event, all gastrointestinal bleeding, and a composite efficacy endpoint of all-cause mortality/thromboembolic event or unplanned revascularization according to baseline use of a proton pump inhibitor.

resultsOf 2678 analyzed patients, 1641 (61.3%) were receiving a proton pump inhibitor at baseline. Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05). For gastrointestinal bleeding, no interaction was observed between study treatment and proton pump inhibitor use (interaction p values 0.84 and 0.62 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin triple therapy).

conclusionsDabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy, regardless of proton pump inhibitor use at baseline, in patients with atrial fibrillation who underwent percutaneous coronary intervention. Risk of the composite efficacy endpoint appeared to be similar for dabigatran dual therapy vs warfarin triple therapy in patients receiving/not receiving a proton pump inhibitor. CLINICALTRIALS. GOV UNIQUE IDENTIFIER: NCT02164864.

Indexed as

AgedAnticoagulantsAtrial FibrillationDabigatranDrug Therapy, CombinationFemaleHumansMalePercutaneous Coronary InterventionProspective StudiesProton Pump InhibitorsWarfarinAnticoagulantsDabigatranProton Pump InhibitorsWarfarin

Identifiers

PMID32562206
PMCPMC7320045
OpenAlexW3036195168

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.