Evidence map›Paper›PMID 24906369›Full record

SynthesisJournal of the American Heart Association2014

Dabigatran etexilate and risk of myocardial infarction, other cardiovascular events, major bleeding, and all-cause mortality: a systematic review and meta-analysis of randomized controlled trials.

Jonathan Douxfils, Fanny Buckinx, François Mullier, Valentine Minet, Véronique Rabenda, Jean-Yves Reginster, Philippe Hainaut, Olivier Bruyère, Jean-Michel Dogné

Open access · goldAbstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Journal of the American Heart Association, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 1 pooled it
11.4field-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

37 citing papers in PubMed, 1 synthesis or guideline pooled it, 100 citations in OpenAlex.

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  18. The coagulation system in atherothrombosis: Implications for new therapeutic strategies.Research and practice in thrombosis and haemostasis · 2018
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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

9 authors at 3 institutions in 1 country.

Jonathan DouxfilsDepartment of Pharmacy, Namur Thrombosis and Hemostasis Center (NTHC), Namur Research Institute for LIfe Sciences (NARILIS), University of Namur, Namur, Belgium (J.D., F.M., V.M., J.M.D.).
Fanny BuckinxDepartment of Public Health, Epidemiology and Health Economics, University of Liege, Liege, Belgium (F.B., R., J.Y.R., O.B.).
François MullierDepartment of Pharmacy, Namur Thrombosis and Hemostasis Center (NTHC), Namur Research Institute for LIfe Sciences (NARILIS), University of Namur, Namur, Belgium (J.D., F.M., V.M., J.M.D.) Hematology Laboratory, Namur Thrombosis and Hemostasis Center (NTHC), Namur Research Institute for Life Sciences (NARILIS), CHU Dinant-Godinne UCL Namur, Yvoir, Belgium (F.M.).
Valentine MinetDepartment of Pharmacy, Namur Thrombosis and Hemostasis Center (NTHC), Namur Research Institute for LIfe Sciences (NARILIS), University of Namur, Namur, Belgium (J.D., F.M., V.M., J.M.D.).
Véronique RabendaDepartment of Public Health, Epidemiology and Health Economics, University of Liege, Liege, Belgium (F.B., R., J.Y.R., O.B.).
Jean-Yves ReginsterDepartment of Public Health, Epidemiology and Health Economics, University of Liege, Liege, Belgium (F.B., R., J.Y.R., O.B.).
Philippe HainautDepartment of General Internal Medicine, Cliniques Universitaires Saint Luc, UCL, Bruxelles, Belgium (P.H.).
Olivier BruyèreDepartment of Public Health, Epidemiology and Health Economics, University of Liege, Liege, Belgium (F.B., R., J.Y.R., O.B.).
Jean-Michel DognéDepartment of Pharmacy, Namur Thrombosis and Hemostasis Center (NTHC), Namur Research Institute for LIfe Sciences (NARILIS), University of Namur, Namur, Belgium (J.D., F.M., V.M., J.M.D.).
University of Liège · BEUniversity of Namur · BECliniques Universitaires Saint-Luc · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSignals of an increased risk of myocardial infarction (MI) have been identified with dabigatran etexilate in randomized controlled trials (RCTs). METHODS AND RESULES: We conducted searches of the published literature and a clinical trials registry maintained by the drug manufacturer. Criteria for inclusion in our meta-analysis included all RCTs and the availability of outcome data for MI, other cardiovascular events, major bleeding, and all-cause mortality. Among the 501 unique references identified, 14 RCTs fulfilled the inclusion criteria. Stratification analyses by comparators and doses of dabigatran etexilate were conducted. Peto odds ratio (ORPETO) values using the fixed-effect model (FEM) for MI, other cardiovascular events, major bleeding, and all-cause mortality were 1.34 (95% CI 1.08 to 1.65, P=0.007), 0.93 (95%CI 0.83 to 1.06, P=0.270), 0.88 (95% CI 0.79 to 0.99, P=0.029), and 0.89 (95% CI 0.80 to 1.00, P=0.041). When compared with warfarin, ORPETO values using FEM were 1.41 (95% CI 1.11 to 1.80, P=0.005), 0.94 (95%CI 0.83 to 1.06, P=0.293), 0.85 (95% CI 0.76 to 0.96, P=0.007), and 0.90 (95% CI 0.81 to 1.01, P=0.061), respectively. In RCTs using the 150-mg BID dosage, the ORPETO values using FEM were 1.45 (95% CI 1.11 to 1.91, P=0.007), 0.95 (95% CI 0.82 to 1.09, P=0.423), 0.92 (95% CI 0.81 to 1.05, P=0.228), and 0.88 (95% CI 0.78 to 1.00, P=0.045), respectively. The results of the 110-mg BID dosage were mainly driven by the RE-LY trial.

conclusionsThis meta-analysis provides evidence that dabigatran etexilate is associated with a significantly increased risk of MI. This increased risk should be considered taking into account the overall benefit in terms of major bleeding and all-cause mortality.

Indexed as

BenzimidazolesCardiovascular DiseasesDabigatranFactor Xa InhibitorsHemorrhageHumansMortalityMyocardial InfarctionPyridinesRandomized Controlled Trials as TopicRisk FactorsVenous ThromboembolismBenzimidazolesDabigatranFactor Xa InhibitorsPyridinesall‐cause mortalitydabigatran etexilatemajor bleedingmyocardial infarction

Identifiers

PMID24906369
PMCPMC4309041
OpenAlexW2145530642

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.