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Editor's Correspondence |

Dabigatran and Myocardial Infarction: Meta-Illusion?

Luis C. L. Correia, MD, PhD; Antonio A. Lopes, MD, MPH, PhD
Arch Intern Med. 2012;172(10):823. doi:10.1001/archinternmed.2012.836.
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We read with great interest the article by Uchino and Hernandez.1 By performing a meta-analysis of 7 randomized trials, they suggested that dabigatran therapy is associated with increased risk of myocardial infarction (MI) or acute coronary syndrome (ACS). Even though meta-analyses provide strong evidence for efficacy and safety, the role of chance should always be taken into account before definite conclusions.

The suspicion that MI risk could be higher in patients receiving dabigatran compared with warfarin was raised by the results of the landmark Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Trial, which enrolled more than 18 000 patients with atrial fibrillation.2 Dabigatran was associated with lower risk of the primary outcome (stroke or systemic embolism) and showed similar risk of the primary safety outcome (major hemorrhage). However, MI, one of several secondary outcomes, had an annual incidence of 0.74% for patients randomized to dabigatran therapy, 150 mg twice daily, and 0.53% for warfarin, corresponding to a 38% higher risk. On the basis on this finding, Uchino and Hernandez performed the meta-analysis, which apparently confirms the suspicion: a 33% higher risk of MI or ACS in patients taking dabigatran. However, we should recognize the possibility of this finding resulting from methodological artifact.

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May 28, 2012
Ken Uchino, MD; Adrian V. Hernandez, MD, PhD
Arch Intern Med. 2012;172(10):823. doi:10.1001/archinternmed.2012.1154.
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