Education Blog for Healthcare Professionals

Major Bleeding on Dabigatran (Pradaxa) – Interesting Publication

Stephan Moll, MD writes…

Interesting publication this week in Circulation: “Management and outcomes of major bleeding during treatment with dabigatran or warfarin” (Majeed A et al; published online Sept 30,2013;  full publication is here).  The management and prognosis of major bleeding in patients treated with dabigatran or warfarin was compared, pooling data of the major bleeds that occurred in 5 phase III dabigatran trials. 1,121 major bleeds occurred in 27,419 patients treated with warfarin or dabigatran.


The noteworthy findings: 

  1. Patients with major bleeding on dabigatran (Pradaxa) do not fare worse than patients with major bleed on warfarin (regarding 30 day mortality). They may actually fare a little better, as evidence by a shorter stay in the intensive care unit.  That is reassuring when discussing the choice of the anticoagulant (warfarin versus dabigatran) with a patient.
  2. There were (as we already knew from previous publications) significantly less intracranial bleeds on dabigatran than on warfarin; however, there were more GI bleeds on dabigatran (supplemental table 1). This is noteworthy, as many would view an intracranial bleed as more worrisome and detrimental than a gastrointestinal bleed.
  3. Warfarin reversal is done suboptimally in clinical practice: In patients with major bleeding on warfarin, (i) only 30 % of patients received vitamin K and (ii) only 1.2 % of patients received a prothrombin complex concentrate (PCC); 30 % received FFP.  This is noteworthy, as guidelines (ACCP 2012) suggest that in case of major bleeding on warfarin PCCs be given rather than plasma (FFP); and vitamin K should be standard of care in warfarin reversal.  The observation in this Circulation publication reflects that reversal of warfarin therapy is often suboptimally done, even though  appropriate tools exist, i.e. vitamin K and PCCs  (see also Clot Connect’s Kcentra discussion here).


Disclosure:  I have consulted for Boehringer-Ingelheim.

Last updated:  Oct 2nd, 2013

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