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FACP. Colegio de médicos de Tarragona Nº 4305520 / fgcapriles@gmail.com




Friday, November 6, 2015


R.E.B.E.L. EM - November 5, 2015 - Posted by Scott Wieters 
"We have written about the new Non-Vitamin K Oral Anti Coagulants (NOACs). Many have jokingly referred to them as the “Noreversabans.” Taking these drugs is a high risk, high reward type of decision. While we recognize the benefits of quick anticoagulation without a need to bridge, as well as being more stable and having less interactions than Coumadin, these drugs are dangerous with serious bleeding concerns. Recently, Dabigatran was likened to “Dancing with the Devil”. For those of us in EM and Critical Care practice, there are no good options for reversing these agents. Once taken there is no turning back… until now?
There is a game changing drug, Idarucizumab, now FDA approved as of October 16, 2015 for the reversal of the new NOAC Dabigatran. Lets take a look at the drug, its road to approval, and what evidence we are dealing with to date. At the end, we will give you a skeptical, evidence based evaluation and balance it with a humble commitment to how we would move forward given the data in true REBEL style... 
The Truth:
We can say that Idarucizumab hypothetically shows promise as being a potentially good strategy for reversing Dabigatran in patients requiring reversal. Based on the existing limited data, it seems safe to administer to patients. Reversal of Dabigatran by Idarucizumab must be studied in larger numbers of patients by unbiased investigators and in comparison to other competing strategies recommended by expert panels before it can be deemed the hands down reversal agent of choice for Dabigatran.Further work needs to be done to bring the level of evidence beyond what we judge to be level C. Based on this level of evidence we can only give this a IIb recommendation. Then again, the competing strategies and evidence for management of the life threatening bleeding patient on Dabigatran are equally if not less convincing and promising than Idarucizumab. 
Clinical Bottom Line: For now, if we had to choose to give this medicine to a loved one who was needing emergent reversal for a serious life threatening bleed, we are between a rock and a hard place. We may be forced to use this therapy despite limited evidence at this time."