Comparing Dabigatran, Apixaban, and Rivaroxaban in the Absence of Head-to-Head Trials

Summary and Comment |
February 23, 2017

Comparing Dabigatran, Apixaban, and Rivaroxaban in the Absence of Head-to-Head Trials

  1. Allan S. Brett, MD

In an observational study, apixaban was associated with the least major bleeding.

  1. Allan S. Brett, MD

U.S. clinicians have a choice of four direct-acting oral anticoagulants (DOACs), but head-to-head trials are lacking. In this observational study, Mayo Clinic researchers used an insurance database to compare effectiveness and safety of the three most-commonly prescribed DOACs (dabigatran [Pradaxa], apixaban [Eliquis], and rivaroxaban [Xarelto]) in patients with nonvalvular atrial fibrillation. Using propensity-score matching, demographically and clinically similar cohorts were created for each two-way comparison: The rivaroxaban–dabigatran comparison had 15,800 patients in each group, and the apixaban–dabigatran and apixaban–rivaroxaban comparisons had about 6500 patients in each group. Results were published in two separate articles.

For preventing stroke or systemic embolism, all three drugs performed similarly. However, for overall major bleeding requiring hospital admission, the following statistically significant differences were noted:

  • More events with rivaroxaban than with dabigatran (about 1 more per 100 person-years)

  • Fewer events with apixaban than with dabigatran (about 1 fewer per 100 person-years)

  • Fewer events with apixaban than with rivaroxaban (about 2 fewer per 100 person-years)

For gastrointestinal bleeding (responsible for most major bleeding events), findings closely paralleled those for overall major bleeding listed above. For the small number of intracranial bleeding episodes, significantly more events occurred with rivaroxaban than with dabigatran (0.53 vs. 0.26 per 100 person-years; P=0.02); no significant differences were found for the other two pairwise comparisons.

Comment

Apixaban was associated with less major bleeding than the other two drugs in this observational study. However, patients to whom these drugs were prescribed could have differed in subtle ways that were not captured by propensity matching. Another way to address absence of head-to-head trials is “network meta-analysis,” in which outcomes of randomized DOAC-versus-warfarin trials are compared indirectly with each other. Several network meta-analyses also have suggested similar efficacy — but less major bleeding — with apixaban than with the other two agents in patients with atrial fibrillation.

Editor Disclosures at Time of Publication

  • Disclosures for Allan S. Brett, MD at time of publication Nothing to disclose

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