Primary outcome for fewer patients receiving rivaroxaban plus aspirin, but more major bleeding
MONDAY, Aug. 28, 2017 (HealthDay News) — Rivaroxaban plus aspirin is superior to aspirin alone for patients with stable atherosclerotic vascular disease, according to a study published online Aug. 27 in the New England Journal of Medicine. The research was published to coincide with the European Society of Cardiology Congress 2017, held from Aug. 26 to 30 in Barcelona, Spain.
John W. Eikelboom, M.B., B.S., from McMaster University in Hamilton, Canada, and colleagues conducted a double-blind trial involving 27,395 participants with stable atherosclerotic vascular disease. Patients were randomized to receive either rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily). After a mean follow-up of 23 months, the study was stopped for superiority of rivaroxaban plus aspirin.
The researchers found that the primary outcome (composite of cardiovascular death, stroke, or myocardial infarction) occurred in fewer patients in the rivaroxaban-plus-aspirin group than in the aspirin-alone group (4.1 versus 5.4 percent; hazard ratio, 0.76); however, more patients in the rivaroxaban-plus-aspirin group had major bleeding events (3.1 versus 1.9 percent; hazard ratio, 1.70). No significant between-group difference was seen in intracranial or fatal bleeding. Overall, there were deaths in 3.4 and 4.1 percent of patients in the rivaroxaban-plus-aspirin and the aspirin-alone groups (hazard ratio, 0.82).
“Among patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes and more major bleeding events than those assigned to aspirin alone,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Bayer, which funded the study.
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