Risk of GI Bleeding With Rivaroxaban vs. Other DOACs
- The use of rivaroxaban was associated with higher overall rates of GI bleeding compared to apixaban in all patients and compared with apixaban and dabigatran in patients with atrial fibrillation.
- Manual chart review may offer greater sensitivity for identification of GI bleeding events compared to ICD-10 code data alone and should be a consideration for future registry studies.
What is the risk of gastrointestinal (GI) bleeding in patients receiving rivaroxaban compared with other direct oral anticoagulants (DOACs)?
This was a population-based cohort study of 5,868 patients who filled a new prescription for a DOAC (apixaban [n = 2,157], dabigatran [n = 494], or rivaroxaban [n = 3,217]) between March 1, 2014–February 28, 2019. Patients were excluded if they had filled a DOAC prescription in the preceding 12 months, received rivaroxaban 2.5 mg, had end-stage renal disease, mechanical heart valve, mitral stenosis, or permanent residence outside Iceland. The primary outcome was any clinically relevant GI bleeding identified by International Classification of Diseases, 10th revision (ICD-10) codes, endoscopic procedure results, and the National Death Registry with all events subsequently verified by manual chart review. Sensitivity and specificity were calculated for utilization of previously validated ICD-10 code data alone compared to the study methods for the identification of GI bleeding.
Rivaroxaban was the most filled DOAC prescription (54.8%), followed by apixaban (36.8%), then dabigatran (8.4%) with a mean follow-up time of 1.6 years, 1.2 years, and 1.8 years, respectively. A total of 241 GI bleeding events were identified, 135 originating from the lower GI tract, and 146 classified as major bleeding by International Society on Thrombosis and Haemostasis criteria. Only 130 GI bleeding events were identified using ICD-10 codes alone, resulting in a specificity of 99.9% and sensitivity of 53% for this methodology compared with the method utilized by the investigators.
Rivaroxaban demonstrated higher rates of overall GI bleeding compared to apixaban (3.2 vs. 2.5 events per 100 person-years; hazard ratio [HR], 1.42; 95% confidence interval [CI], 1.04-1.93). Rivaroxaban was associated with numerically higher rates of overall GI bleeding (3.2 vs. 1.9 events per 100 person-years) compared to dabigatran (HR, 1.63; 95% CI, 0.91-2.92). Rivaroxaban was associated with higher rates of upper GI bleeding compared with dabigatran (1 vs. 0.3 events per 100 person-years; HR, 3.75; 95% CI, 1.32-10.71). Sensitivity analysis of only patients with atrial fibrillation demonstrated rivaroxaban had higher overall rates of GI bleeding than apixaban (3.2 vs. 2.4 events per 100 person-years; HR, 1.4; 95% CI, 1.01-1.94) and dabigatran (3.2 vs. 1.6 events per 100 person-years; HR, 2.04; 95% CI, 1.17-3.55).
This population-based study demonstrated that rivaroxaban was associated with a higher overall risk of GI bleeding compared to apixaban and dabigatran in all patients, though for dabigatran, this should be interpreted cautiously in the setting of wide confidence intervals.
The current study was unique in that GI bleeding events were adjudicated through chart review, which resulted in greater sensitivity to identify these events compared to the use of ICD-10 codes alone. The higher rates of GI bleeding reported in this trial compared to prior registry studies suggests that these prior studies may have underestimated the true incidence of GI bleeding. This study adds to the current body of literature assessing relative rates of GI bleeding for rivaroxaban, apixaban, and dabigatran and should assist practitioners when making prescribing decisions in patients at high risk of GI bleeding.
Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Cardiovascular Care Team, Prevention, Anticoagulation Management and Atrial Fibrillation, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias
Keywords: Arrhythmias, Cardiac, Anticoagulants, Atrial Fibrillation, Dabigatran, Endoscopy, Gastrointestinal Hemorrhage, Hemostasis, Lower Gastrointestinal Tract, Rivaroxaban, Secondary Prevention, Thrombosis, Vascular Diseases
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