Apixaban Ups Bleeding Without Reducing Ischemic Events

Trial evaluating addition of apixaban to antiplatelet therapy terminated prematurely

TUESDAY, July 26 (HealthDay News) -- Adding 5 mg of apixaban twice daily to antiplatelet therapy among high-risk patients after an acute coronary syndrome increases the risk of bleeding events without a significant reduction in recurrent ischemic events, according to a study published online July 24 in the New England Journal of Medicine.

John H. Alexander, M.D., M.H.S., from the Duke University Medical Center in Durham, N.C., and colleagues investigated the effect of adding apixaban to antiplatelet therapy among 7,392 patients with recent acute coronary syndrome and at least two additional risk factors for recurrent ischemic effects. A total of 3,705 participants were randomly assigned to a 5-mg twice-daily dose of apixaban, and 3,687 to placebo. Participants were followed up for an average of 241 days. Cardiovascular death, myocardial infarction, or ischemic stroke were the primary end points, and major bleeding was the main safety outcome of the study. The trial was terminated prematurely.

The investigators found that 279 patients receiving apixaban therapy, and 293 on placebo therapy reached the primary end point (13.2 and 14.0 events per 100 patient-years, respectively; hazard ratio [HR] with apixaban, 0.95). Major bleeding occurred in significantly more patients who received at least one dose of apixaban compared to those who received placebo (2.4 versus 0.9 events per 100 patient-years; HR with apixaban, 2.59). Apixaban therapy resulted in a higher number of intracranial and fatal bleeding events than placebo therapy.

"The addition of apixaban, at a dose of 5 mg twice daily, to antiplatelet therapy in high-risk patients after an acute coronary syndrome increased the number of major bleeding events without a significant reduction in recurrent ischemic events," the authors write.

The study was funded by Bristol-Myers Squibb and Pfizer.

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