A Survey of a Single Centerʼs Experience with Dabigatran (Pradaxa®) and Physicianʼs Knowledge in Management of Related Gastrointestinal Bleeding

Abstract

Purpose: In 2010, the United States Food and Drug Administration approved dabigatran (Pradaxa®), a new oral anticoagulation drug. In addition to gaining FDA approval for use in atrial fibriliation, the RELY trial also demonstrated that patients taking dabigatran were 1.5 times more likely to have a major gastrointestinal (GI) bleeding event. To date, although there are proposed recommendations for withholding dabigatran peri-operatevily, clear evidence based guidelines on the timing of dabigatran administration both prior to and after an endoscopic procedure are lacking. We aimed to review clinicians' clinical experiences with and management approach to dabigatran related gastrointestinal bleeding events. Methods: We created a 12 question anonymous survey to assess clinicians' clinical experiences, level of knowledge of proper dabigatran administration and preferred management approach to any related GI bleeding events (Table 1). Included in the study were all internal medicine house staff, medical attendings, gastroenterology fellows and attendings employed in 2011 at the Beth Israel Medical center, New York, NY.Table: Respondent level of training ( N =71)Results: During the study period, a total of 71 physicians responded to our survey. The majority (70%) of respondents had cared for at least 1 patient taking dabigatran during the past year. Notably, 22.4% of respondents have cared for patients with GI bleeding secondary to dabigatran. The location of bleeding was essentially equally divided between upper (53.8%) and lower (46.2%) GI anatomy. Only half of the respondents (56.3%) believe that no serum marker is currently available to monitor dabigatran levels. Surprisingly, only 42% of respondents take into account renal function when making recommendations regarding holding dabigatran peri-endoscopy. While the majority (73.2%) of respondents would attempt optimal supportive care as a primary treatment for bleeding complication, approximately 40% of respondents would choose fresh frozen plasma as treatment for life threatening gastrointestinal hemorrhage. Finally, the majority (34%) of respondents would hold dabigatran 1-2 days prior to elective endoscopy, while the most common answer given for timing to withholding dabigatran post-endoscopy was “I don't know.” Conclusion: Despite our centers' growing experience with dabigatran use, we observed a wide range in knowledge and perception of peri-endoscopic dabigatran administration and any related GI bleeding complications. As the utilization and popularity of dabigatran continues to expand, there is an increasing need for more objective algorithms outlining the proper periendoscopic administration of dabigatran and management of any related GI bleeding complications.Table: [1429] Survey responses