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Risk of gastrointestinal bleeding with dabigatran: a head-to-head comparative study with rivaroxaban
Muhammed Sherid1, Humberto Sifuentes, Samian Sulaiman
1Section of Gastroenterology and Hepatology, Georgia Regents University, Augusta, Ga., USA.
Insights
Gastrointestinal bleeding risk with dabigatran and rivaroxaban is similar, with both showing increased risk in the first 40 days of use. Concomitant dual antiplatelet use with rivaroxaban increased bleeding risk.
Area of Science:
- Pharmacology
- Gastroenterology
- Clinical Medicine
Background:
- Gastrointestinal (GI) bleeding risk associated with direct oral anticoagulants (DOACs) like dabigatran and rivaroxaban requires further investigation.
- Comparative data on GI bleeding incidence between dabigatran and rivaroxaban is limited.
Purpose of the Study:
- To compare the risk of gastrointestinal bleeding between patients taking dabigatran and those taking rivaroxaban.
- To identify factors associated with increased GI bleeding risk in patients on these DOACs.
Main Methods:
- Retrospective analysis of medical records from October 2010 to April 2013.
- Inclusion of 374 patients on either dabigatran or rivaroxaban from two hospitals.
- Multivariate analysis to assess bleeding risk factors.
Main Results:
- Overall GI bleeding incidence was similar between dabigatran (5.3%) and rivaroxaban (4.8%).
- Both dabigatran and rivaroxaban showed a higher bleeding risk within the first 40 days of treatment.
- Dual antiplatelet therapy with rivaroxaban and prior GI bleeding were associated with significantly increased bleeding risk.
Conclusions:
- Dabigatran is not associated with a higher incidence of GI bleeding compared to rivaroxaban.
- The initial 40 days of treatment with either dabigatran or rivaroxaban pose a heightened risk for GI bleeding.
- Risk stratification for rivaroxaban should consider concomitant dual antiplatelet use and history of GI bleeding.
Introduction:
The risk of gastrointestinal (GI) bleeding of dabigatran and rivaroxaban is relatively unexplored. The aim of our study was to compare this risk in both drugs.
Methods:
We examined the medical records of patients on either dabigatran or rivaroxaban from October 2010 to April 2013 in two hospitals.
Results:
A total of 374 patients (147 rivaroxaban vs. 227 dabigatran) were identified. GI bleeding occurred in 5.3% in the dabigatran when compared to 4.8% in the rivaroxaban group (p = 0.8215). Multivariate analysis showed that the odds of GI bleeding while on dabigatran for ≤40 days when compared to ≥40 days was 8.3 (p < 0.0001). In the rivaroxaban group, patients who were on the drug for ≤40 days had a higher incidence of bleeding when compared to those >40 days (OR = 2.8, p = 0.023). Concomitant use of antiplatelets (single or dual) or non-steroidal anti-inflammatory drugs was not associated with increased bleeding in the dabigatran group; however, the use of dual antiplatelet agents with rivaroxaban was associated with an increased risk of GI bleeding (OR = 7.4, p = 0.0378). Prior GI bleeding had a higher risk of bleeding in the rivaroxaban group (OR = 15.5, p = 0.0002).
Conclusion:
Dabigatran was not associated with a higher incidence of GI bleeding. Both drugs had a higher bleeding risk in the first 40 days.
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