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[Argirios Argiriou]

January 17, 2017

Risks for GI Bleeding with Direct Oral Anticoagulants

David J. Bjorkman, MD, MSPH (HSA), SM (Epid.) reviewing Abraham NS et al. Gastroenterology 2016 Dec 31.

Risks were lower with apixaban than with dabigatran or rivaroxaban.

Direct oral anticoagulants (DOACs) increase the risk for gastrointestinal bleeding (GIB). To identify risk differences among DOACs, investigators performed 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.

The authors conclude that 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.

COMMENT

This study reduces the potential confounding of many retrospective database studies by using propensity matching to create independent paired groups for comparing the DOACs against each other. The differences in GIB risk seen between DOACs in this study may have important clinical implications, but they need to be verified in prospective studies.

Note to readers: At the time NEJM Journal Watch reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.

EDITOR DISCLOSURES AT TIME OF PUBLICATION

Disclosures for David J. Bjorkman, MD, MSPH (HSA), SM (Epid.) at time of publication
Leadership positions in professional societiesWorld Gastroenterology Organization (President)
CITATION(S):

Abraham NS et al. Gastrointestinal safety of direct oral anticoagulants: A large population-based study. Gastroenterology 2016 Dec 31; [e-pub]. (Δεν είναι ορατοί οι σύνδεσμοι (links). Εγγραφή ή Είσοδος)
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READER COMMENTS (1)

 ReplyMoh Other Healthcare Professional, Cardiology
20 Jan 2017 10:27 AM
This retrosp. Data analysis is not reflecting real life experience specially the incidence of GI bleeding with riva and dabi is not matching the clinical experience.

Δεν είναι ορατοί οι σύνδεσμοι (links). Εγγραφή ή Είσοδος