Clinical Edge

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.

Citation:

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.

Commentary:

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

  1. Ruff C, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383(9921):955–962. 10.1016/S0140-6736(13)62343-0.

This Week's Must Reads

Acute Illness and Cannabis Use in Adults, Ann Intern Med; ePub 2019 Mar 26; Monte, et al

Pregnancy History and Risk of Miscarriage, BMJ; ePub 2019 Mar 20; Magnus, et al

Firearms Mortality Among US Schoolchildren, Am J Med; ePub 2019 Mar 25; Rubenstein, et al

Rapid Point of Care Test for Influenza, J Am Board Fam Med; 2019 Mar; Dale, et al

Sleep Disturbance and Chronic Pain Intensity, Clin J Pain; ePub 2019 Mar 25; Burgess, et al

Must Reads in Cardiology

Consumption of SSBs & Risk of Mortality, Circulation; ePub 2019 Mar 18; Malik, et al

Dietary Cholesterol or Egg Consumption & CVD, JAMA; 2019 Mar 19; Zhong, Van Horn, et al

Physical Activity & Incidence of CHD & CVD in Women, JAMA Netw Open; ePub 2019 Mar 15; LaCroix, et al

Intensive BP Control in Adults with Hypertension Who Smoke, JAMA Netw Open; ePub 2019 Mar 8; Scarpa, et al

Leisure-Time Physical Activity Across Adulthood, JAMA Netw Open; ePub 2019 Mar 8; Saint-Maurice, et al