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A pivotal phase III trial has reported similar bleeding rates for dabigatran and warfarin in stroke prevention. However the incidence of bleeding-related fatalities in clinical practice has not been evaluated. Whether dabigatran is associated with worse bleeding-related outcomes is unknown.
We evaluated reports of dabigatran and warfarin induced bleeding events from the United States submitted to the FDA Reporting System through 2011–2012. Bleeding events and related fatalities were determined. The bleeding-related mortality rate based on a reported 725,000 dabigatran treated patients was estimated.
Bleeding-related fatalities increased during the reported period for dabigatran compared to a stable number of reports with warfarin (Figure 1). Dabigatran was the primary or secondary agent in 4,270 bleeding events with 638 bleeding-related fatalities. In comparison, warfarin had 827 bleeding events with 44 bleeding-related fatalities. We estimated a lower bound of 88 bleeding-related fatalities per 100,000 dabigatran treated patients. Because of under-reporting bias these estimates represent a lower bound on the population bleeding mortality rates.
The total number of bleeding-related fatalities for dabigatran have greatly exceeded warfarin. Significant reporting bias exists in the FDA reporting system. A more comprehensive data source is needed to determine the true incidence and risks for fatal bleeding episodes.
Oral Contributions West, Room 3009
Sunday, March 10, 2013, 9:15 a.m.-9:30 a.m.
Session Title: Joint Session of the Heart Rhythm Society and the American College of Cardiology: Anticoagulation in Atrial Fibrillation -Management Questions with New Anticoagulants
Abstract Category: 4. Arrhythmias: AF/SVT
Presentation Number: 914-8
- 2013 American College of Cardiology Foundation