Gastrointestinal Safety of Direct Oral Anticoagulants: A Large Population-Based Study

Gastroenterology 2016 Dec. 31, Vol. 152, Pgs. 932-934

Neena S. Abraham; Peter A. Noseworthy; Xiaoxi Yao; Lindsey R. Sangaralingham; and Nilay D. Shah

Abstract available at: http://www.jwatch.org/na43242/2017/01/17/risks-gi-bleeding-with-direct-oral-anticoagulants

This study was a retrospective, propensity-matched analysis of administrative claims data on more than 120 million privately insured Medicare Advantage enrollees.

Three matched-pair cohorts were created from 372,380 patients with nonvalve atrial fibrillation who were exposed to dabigatran, rivaroxaban, or apixaban during a period of 4 years and 5 months. Results were as follows:

• More GIB events occurred with rivaroxaban than with dabigatran (2.74 vs. 2.02/100 patient-years; hazard ratio, 1.20; 95% confidence interval, 1.00–1.45).
• Fewer GIB events occurred with apixaban than with dabigatran (1.38 vs. 2.73/100 patient-years; HR. 0.39; 95% CI, 0.27–0.58).
• Fewer GIB events also occurred with apixaban than with rivaroxaban (1.34 vs. 3.54/100 patient-years; HR, 0.33; 95% CI, 0.22–0.49).
• Comparing apixaban with rivaroxaban and with dabigatran, the number needed to harm was 45 and 74, respectively.
• GIB risk was greater for all agents in older patient cohorts.

Apixaban had the lowest risk and rivaroxaban had the highest risk. They also note that apixaban had the fewest GIB events in patients ≥75 years of age.

Conclusion: Risks were lower with apixaban that with dabigatran or rivaroxaban. This is raw data that was collected retrospectively, so more prospective studies should determine if it’s in fact less risky to use Apixaban in the elderly.