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DOACs Go Head-to-Head on Safety, Efficacy in US Cohort Study


Safety and efficacy of apixaban bested rivaroxaban in analysis of new users from a US nationwide commercial healthcare claims database.

Factor Xa anticoagulation factor

Rates of ischemic stroke or systemic embolism were lower among adults with non-valvular atrial fibrillation treated with apixaban vs those taking rivaroxaban, according to recent findings. Apixaban also was associated with a more favorable safety profile, ie, a lower incidence of intracranial hemorrhage or gastrointestinal (GI) bleeding.

The 2 direct oral anticoagulants (DOACs) are the most commonly prescribed in the class of agents introduced in 2011. The new study, published online March 10 in the Annals of Internal Medicine, is, however, the first head-to-head analysis of the drugs' safety and efficacy.  

The active-comparator, retrospective cohort study, led by Michael Fralick, MD, PhD, of Brigham and Women's Hospital in Boston, analyzed data from a US nationwide commercial healthcare claims database, looking at claims made between December 28, 2012 to January 1, 2019 for adults newly prescribed apixaban 5 mg (n = 59 172) or rivaroxaban 20 mg (n = 40 706). A total of 39 351 new users of apixaban were propensity-score matched to 39 351 patients newly prescribed rivaroxaban. Mean age was 69 years, 40% of patients were women, and mean follow-up was an average of 290 days.

The primary effectiveness outcome was a composite of ischemic stroke or systemic embolism. The primary safety outcome was a composite of intracranial hemorrhage or GI bleeding.

Results: The incidence rate of ischemic stroke or systemic embolism was 6.6 per 1000 person-years for adults prescribed apixaban vs 8.0 per 1000 person-years for those prescribed rivaroxaban (hazard ratio [HR], 0.82 [95% CI, 0.68 to 0.98]; rate difference, 1.4 fewer events per 1000 person-years [CI, 0.0 to 2.7]).

Adults prescribed apixaban also had a lower rate of GI bleeding or intracranial hemorrhage (12.9 per 1000 person-years) compared with those prescribed rivaroxaban (21.9 per 1000 person-years), corresponding to an HR of 0.58 (CI, 0.52 to 0.66) and a rate difference of 9.0 fewer events per 1000 person-years (CI, 6.9 to 11.1).

The authors point to several limitations of the observational study design inlcuding the role of unmeasured confounding. They acknowledge incomplete laboratory data, absence of information on concomitant use of over-the-counter medications, and use of diagnostic codes vs outcome adjudication to define patient outcomes.

“Apixaban may be safer and more effective than rivaroxaban for treating nonvalvular atrial fibrillation,” wrote study authors. “Until head-to-head clinical trial data are available, the results of our study, which included a large sample of patients seen in routine care, provides updated evidence in support of apixaban for treating nonvalvular atrial fibrillation.”


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