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Gastrointestinal Bleeding in Patients With Atrial Fibrillation Treated With Rivaroxaban or Warfarin: ROCKET AF Trial
Matthew W Sherwood1, Christopher C Nessel2, Anne S Hellkamp1
1Division of Cardiovascular Medicine, Duke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina.
Journal of the American College of Cardiology
|November 28, 2015
Summary
Rivaroxaban increased gastrointestinal (GI) bleeding compared to warfarin in the ROCKET AF trial. Minimizing modifiable risk factors is crucial for patients on oral anticoagulation.
Area of Science:
- Cardiology
- Gastroenterology
- Pharmacology
Background:
- Gastrointestinal (GI) bleeding is a frequent complication associated with oral anticoagulation therapy.
- Understanding the incidence and risk factors for GI bleeding is critical for patient safety.
Purpose of the Study:
- To evaluate the occurrence of GI bleeding in patients treated with rivaroxaban versus warfarin in the ROCKET AF trial.
- To identify independent clinical predictors of GI bleeding in patients receiving oral anticoagulants.
Main Methods:
- Analysis of adjudicated GI bleeding events from the ROCKET AF trial's on-treatment population.
- Utilized multivariable modeling to identify predictors of GI bleeding.
Main Results:
- A total of 14,236 patients were analyzed, with 684 experiencing GI bleeding.
- Rivaroxaban-treated patients showed a significantly higher rate of major or nonmajor clinical GI bleeding compared to warfarin (3.61 vs. 2.60 events/100 patient-years).
- Independent predictors of GI bleeding included baseline anemia, prior GI bleeding history, and long-term aspirin use.
Conclusions:
- Rivaroxaban use was associated with an increased risk of GI bleeding compared to warfarin in the ROCKET AF trial.
- The rate of fatal GI bleeding was low and comparable between the two treatment groups.
- Reducing modifiable risk factors is essential for managing GI bleeding risk in patients on oral anticoagulation.
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