In March 2017 the British Journal of Clinical Pharmacology published this article, “Risk of myocardial infarction in patients with atrial fibrillation using vitamin K antagonists, aspirin or direct acting oral anticoagulants”, which reports on the first retrospective cohort study to compare the risk of acute myocardial infarction (AMI), or heart attack, with use of direct-acting oral anticoagulants (DOACs) with that associated with vitamin K antagonists (VKAs), e.g., warfarin.
The bottom line is that the medical researchers conducting this study found a two-fold increase in the risk of heart attacks with use of Pradaxa (dabigatran) and Xarelto (rivaroxaban) in comparison with warfarin in patients using those drugs for atrial fibrillation (AF) therapy.
Specifically, from the Results section of the Abstract for this March 2017 medical journal article: “The risk of AMI was doubled when we compared current use of DOACs with current use of VKAs [adjusted HR 2.11; 95% confidence interval (CI) 1.08, 4.12]….”
And from the Discussion part of the full article:
In conclusion, our cohort study identified a twofold increase in the risk of AMI when using DOACs, [Xarelto (rivaroxaban)] or [Pradaxa (dabigatran)], in comparison with VKAs, in AF therapy in real-world patients. In addition, our results showed that in AF patients, the risk of AMI with current use of aspirin as monotherapy is higher than with current use of VKAs. VKAs probably have greater beneficial effects on AMI than DOACs. Ongoing research is needed as the use of DOACs increases in the population.
While this observational study reports that there is a correlation between the use of Xarelto (rivaroxaban) or Pradaxa (dabigatran) with an increased risk for myocardial infarction (MI), or heart attack, it is important to keep in mind that correlation does not prove causation.
Rather, in order to definitively answer the question “Do direct oral anticoagulants (DOACs) increase the risk for myocardial infarction (MI), or heart attack”, we will need a well-designed study. One hopes that Boehringer Ingelheim Pharmaceuticals (Pradaxa) or Janssen Pharmaceuticals (Xarelto), as the responsible drug companies, have such a drug-safety study currently underway or planned to begin soon.
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