James A. Reiffel, MD - Novel Oral Anticoagulants - Figure 23

Bleeding Events in RE-LY

The corollary of significant anticoagulation is risk of bleeding.  Looking only at the 150 mg dose of dabigatran, the Figure shows that the intracranial hemorrhage, life-threatening bleed, and any bleed were significantly lower with dabigatran 150 mg than with warfarin (intracranial hemorrhage was dramatically lower; 0.3% vs. 0.8%, a statistically significant 59% reduction in hazard ratio).[96] Risk of a major bleed was lower, but not significantly, with dabigatran, but risk of major gastrointestinal (GI) bleeding was significantly higher with this higher dose of dabigatran than with warfarin

 Reiffel JA. Am J Med 2013; 126: 00-00.