Rivaroxaban Has Mixed Results in Acute Coronary Syndrome

Treatment is associated with increased bleeding risk but lower risk of heart attack and stroke

WEDNESDAY, June 17 (HealthDay News) -- In patients who are stabilized following an acute coronary syndrome, treatment with the oral anti-clotting drug rivaroxaban is associated with an increased risk of significant bleeding but also a decreased risk of major adverse cardiac events, according to a study published online June 16 in The Lancet.

Jessica L. Mega, M.D., of Brigham and Women's Hospital in Boston, and colleagues randomly assigned 3,491 patients who were taking either aspirin or aspirin plus clopidogrel to receive either placebo or rivaroxaban.

Compared to placebo, the researchers found that rivaroxaban was associated with a dose-dependent increased risk of bleeding with hazard ratios of 2.21, 3.35, 3.60, and 5.06 for the respective doses of 5, 10, 15, and 20 milligrams. They also found that rivaroxaban was associated with a significantly reduced rate of death, heart attack, stroke, or severe recurrent ischemia (5.6 versus 7.0 percent; hazard ratio, 0.79).

"The use of an oral factor Xa inhibitor in patients stabilized after an acute coronary syndrome increases bleeding in a dose-dependent manner and might reduce major ischemic outcomes," conclude the authors. "On the basis of these observations, a phase III study of low-dose rivaroxaban as adjunctive therapy in these patients is underway."

This study was supported by Johnson & Johnson Pharmaceutical Research & Development and Bayer Healthcare AG; several authors reported financial relationships with either or both of the companies.

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