Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Is Idarucizumab Safe for Dabigatran Reversal?
N Engl J Med; 2017 Aug 3; Pollack, et al
Idarucizumab rapidly and safely reverses the anticoagulant effect of dabigatran in emergency situations, a recent study found. The multicenter, prospective, open-label study included 503 patients and determined whether 5 g of IV idarucizumab would be able to reverse the anticoagulant effect of dabigatran in patients with uncontrolled bleeding (group A, n=301) or who were about to undergo an urgent procedure (group B, n=202). Researchers found:
- The median maximum percentage reversal of dabigatran was 100%.
- In group A, 137 patients (45.5%) presented with GI bleeding and 98 (32.6%) presented with intracranial hemorrhage.
- Median time to bleeding cessation was 2.5 hours.
- In group B, the median time to the initiation of the intended procedure was 1.6 hours.
- Periprocedural hemostasis was normal in 93% of these patients, mildly abnormal in 5.1%, and moderately abnormal in 1.5%.
- At 90 days, thrombotic events occurred in 6.3% of the patients in group A and in 7.4% in group B.
- Mortality rates were similar in the 2 groups.
Pollack CV, Reilly PA, van Ryn J, et al. Idarucizumab for dabigatran reversal—full cohort analysis. N Engl J Med. 2017;377:431-441. doi:10.1056/NEJMoa1707278.
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Non-vitamin K oral anticoagulant (NOAC) medications was first introduced in 2010 with the approval of dabigatran (Pradaxa). A year later, rivaroxaban (Xarelto) was approved by the FDA, followed by apixaban (Eliquis) and edoxaban (Savaysa) over the next few years. Meta-analysis has shown NOACs to be as effective as warfarin in atrial fibrillation in decreasing ischemic stroke, with improvement in mortality (RR, 0.9) and a decreased risk of hemorrhagic stroke (RR, 0.5).1 Nonetheless, many clinicians have concerns about the lack of ability to quickly reverse anticoagulation with NOACs, as can be done using fresh frozen plasma when warfarin is used. The development and study of idarucizumab represents an important advance in NOAC therapy, providing a predictable, reliable method to rapidly reverse anticoagulation when dabigatran is used for anticoagulation. —Neil Skolnik, MD