Evidence map›Paper›PMID 26944733›Full record

Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2016

Long-term evaluation of dabigatran 150 vs. 110 mg twice a day in patients with non-valvular atrial fibrillation.

Michael D Ezekowitz, John Eikelboom, Jonas Oldgren, Paul A Reilly, Martina Brueckmann, Anthony P Kent, Janice Pogue, Judith Spahr, Andreas Clemens, Herbert Noack and 4 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in 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, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing 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.

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

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

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Review
  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

14 authors.

Michael D EzekowitzSidney Kimmel Medical College, Thomas Jefferson University, 1999 Sproul Rd., Broomall, Philadelphia, PA, USA Lankenau Medical Center, Wynnewood, PA, USA michael.ezekowitz@comcast.net.
John EikelboomPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada.
Jonas OldgrenDepartment of Medical Sciences, Uppsala Clinical Research Centre, Uppsala University, Uppsala, Sweden.
Paul A ReillyBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
Martina BrueckmannBoehringer Ingelheim GmbH & Co. KG, Ingelheim, Germany Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.
Anthony P KentSidney Kimmel Medical College, Thomas Jefferson University, 1999 Sproul Rd., Broomall, Philadelphia, PA, USA.
Janice PoguePopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada.
Judith SpahrLankenau Institute for Medical Research, Wynnewood, PA, USA.
Andreas ClemensBoehringer Ingelheim GmbH & Co. KG, Ingelheim, Germany.
Herbert NoackBoehringer Ingelheim GmbH & Co. KG, Ingelheim, Germany.
Hans-Christoph DienerDepartment of Neurology, University Hospital Essen, Essen, Germany.
Lars WallentinDepartment of Medical Sciences, Uppsala Clinical Research Centre, Uppsala University, Uppsala, Sweden.
Salim YusufPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada.
Stuart J ConnollyPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial allowed patients who completed the trial receiving their assigned dabigatran 150 mg (D150) or 110 mg (D110) twice a day to continue into the Long-term Multicenter Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) trial. This permitted assessment of outcomes over a median of 4.6 and a maximum of 6.7 years, respectively. METHODS AND

resultsThe analysed population included only those patients who completed RE-LY on dabigatran and continued into RELY-ABLE without interruption of assigned dabigatran. Cumulative risk was expressed as Kaplan-Meier plots. Outcomes were compared using Cox proportional hazard modelling. Stroke or systemic embolization rates were 1.25 and 1.54% per year (D150 and D110, respectively); hazard ratio (HR) 0.81 [95% confidence interval (CI): 0.68-0.96] (P = 0.02). Ischaemic stroke was 1.03 (D150) and 1.29%/year (D110); HR 0.79 (95% CI: 0.66-0.95) (P = 0.01). Haemorrhagic stroke rates were 0.11 (D150) and 0.13%/year (D110); HR 0.91 (95% CI: 0.51-1.62) (P = 0.75). Rates of major haemorrhage were 3.34 (D150) and 2.76%/year (D110); HR 1.22 (95% CI: 1.08-1.37) (P = 0.0008). Intracranial haemorrhage rates were 0.32 (D150) and 0.23%/year (D110); HR 1.37 (95% CI: 0.93-2.01) (P = 0.11). Mortality was 3.43 (D150) and 3.55%/year (D110); HR 0.97 (95% CI: 0.87-1.08) (P = 0.54).

conclusionAnnualized rates of all outcomes were constant with better efficacy of D150, less major bleeding with D110, and low intracerebral haemorrhage rates for both doses. There were no additional safety concerns. This is the longest continuous randomized experience of a novel anticoagulant.

Indexed as

AdolescentAdultAgedAged, 80 and overAnticoagulantsAntithrombinsAtrial FibrillationDabigatranDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansIntracranial HemorrhagesKaplan-Meier EstimateMaleMiddle AgedAnticoagulantsAntithrombinsDabigatranWarfarinAtrial fibrillationDabigatran etexilateLong-term outcomeStroke

Identifiers

PMID26944733
PMCPMC4927062

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.