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Idarucizumab Works – At Least in the Lab

August 30, 2017

Spoon Feed
Idarucizumab reverses anticoagulation 100% due to dabigatran in the test tube. It seemed to stop active bleeding in patients in about 2.5 hours, and reported operative hemostasis was good.  But since this was an open label trial with no control group, we don’t know how the outcomes would have compared with patients who were treated with other procoagulants or who were not treated.

Why does this matter?
The only way to reverse the expensive anticoagulant is to use the expensive reversal agent, both made by Boehringer Ingelheim.  They sell the lock and the key, and they funded this study.  Although it seems intuitive that reversal of anticoagulation for serious bleeding would be beneficial to the patient, this study has no control group for comparison with other procoagulants, like PCC, or placebo.

I dare you, cizumab
This was an open label study, RE-VERSE AD, of 5g idarucizumab in 503 patients anticoagulated with dabigatran who had uncontrolled bleeding (mostly GI or intracranial) or needed an emergent procedure.  They found 100% reversal based on diluted thrombin time or ecarin time, which was the primary outcome.  They found bleeding cessation in 2.5 hours in those with uncontrolled bleeding and subjective reporting of adequate intraoperative hemostasis in those needing surgery in 93%.  Interestingly, in a slide show presented to the AHA, time to bleeding cessation was 3.5 – 4.5 hours; not sure how it suddenly became 2.5 hours for this publication (props to EMLoN for this tip).  The big issue is that all patients received the drug.  So the drug worked in the test tube, but was it faster to cease bleeding than other procoagulants or placebo?  We don’t know.  Lack of a control group is a huge limitation – the study drug was compared with…the study drug.

Idarucizumab for Dabigatran Reversal – Full Cohort Analysis. N Engl J Med. 2017 Jul 11. doi: 10.1056/NEJMoa1707278. [Epub ahead of print]

Peer reviewed by Thomas Davis, MD.

What are your thoughts?