Irresponsible Use of NOACs in End-Stage Renal Disease

Frequent readers may have noted this blog is somewhat skeptical regarding the novel oral anticoagulants, with particular criticism reserved for dabigatran.*  The bleeding risks, particularly for dabigatran, are profoundly increased in renal impairment – while the Factor Xa inhibitors simply do not have sufficient safety data to describe their risks in this population.

So, in dialysis patients with zero renal function – wouldn’t it perhaps be safest to continue using our present, time-tested, warfarin anticoagulation strategy?

This review of the Fresenius Medical Care database of end-stage renal patients on dialysis captured 8,064 patients with non-valvular atrial fibrillation who were initiated on anticoagulation between 2010 and 2014.  During this time, 5.9% of patients receiving new anticoagulation were initiated on dabigatran or rivaroxaban, with the remainder started on warfarin or aspirin.  And, dabigatran or rivaroxaban use increased the incidence of minor bleeding, major bleeding, and bleeding-associated mortality – with relative risk increases ranging from ~1.3 for minor bleeding to ~1.7 for hemorrhagic death.  Even rates for ischemic stroke were low in all groups, and no meaningful protective difference for thromboembolic events was observed.  Small baseline differences between the various anticoagulant cohorts are present, but they are probably clinically unimportant.

More bleeding?  More death?  It seems clear it is not responsible medicine to initiate the NOACs in a dialysis population.

“Dabigatran and Rivaroxaban Use in Atrial Fibrillation Patients on Hemodialysis”
http://www.ncbi.nlm.nih.gov/pubmed/25595139

*Disclosure: I provided legal consultation pertaining to dabigatran, with funds paid to my institution.