Does idarucizumab safely reverse anticoagulation in patients taking dabigatran?

Idarucizumab reversed the anticoagulation effects of dabigatran (Pradaxa) in more than 98% of patients and maintained this reversal for 24 hours. It is unfortunate that these researchers did not attempt to identify a similar group of patients who did not receive the drug. The magnitude of mortality reduction or a possible increase in the risk of thrombosis is therefore unknown. (LOE = 4)

Pollack CV Jr, Reilly PA, van Ryn J, et al. Idarucizumab for dabigatran reversal full cohort analysis. N Engl J Med 2017;377(5):431-441.  [PMID:28693366]

Case series

Industry

Inpatient (any location) with outpatient follow-up

This was a case series, with no comparison group, although it seems that it would have been possible to identify a historical control group of similar patients with bleeding who were not given idarucizumab (just say: "I dare you sizzu mab") to reverse the anticoagulant effects of dabigatran. The authors identified 2 groups of adults currently taking dabigatran: Group A included 301 patients with uncontrollable or life-threatening bleeding (as defined by the treating clinician) who required rapid reversal of the anticoagulant, while Group B comprised 202 patients who were judged to require an urgent invasive procedure or surgery within 8 hours. Most of the patients in Group A had gastrointestinal or intracranial bleeding. All patients in both groups received two 2.5-mg infusions of the study drug 5 minutes apart. The primary outcome was the effect on measures of coagulation, such as diluted thrombin time, and the drug did indeed return them to normal values. Of the 203 patients with nonintracranial bleeding, two-thirds had cessation of bleeding within 24 hours, with a median time to cessation of 2.5 hours. In the remaining patients, it could not be determined whether bleeding had stopped. The 30-day mortality rate was 13% in both groups, and 5% experienced a thrombotic event during the 30-day follow-up period. Of course, these clinical outcomes are meaningless without a comparison group.