Eikelboom JW, et al. - This article was written with the objective to assess whether rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary cardiovascular prevention. It was concluded that those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes among patients with the stable atherosclerotic vascular disease and more major bleeding events than those assigned to aspirin alone. They also revealed that rivaroxaban (5 mg twice per day) alone did not result in better cardiovascular outcomes than aspirin alone and resulted in more major bleeding events.

Methods

• For this study, they designed a double-blind trial.
• They randomly assigned 27,395 participants with the stable atherosclerotic vascular disease to receive rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily).
• In this study, the primary outcome was a composite of cardiovascular death, stroke, or myocardial infarction.
• The examination was ceased for the superiority of the rivaroxaban-plus-aspirin group after a mean follow-up of 23 months.

Results

• The current study showed that the primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin group than in the aspirin-alone group (379 patients [4.1%] vs. 496 patients [5.4%]; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; P<0.001; z=-4.126).
• However, major bleeding events occurred in more patients in the rivaroxaban-plus-aspirin group (288 patients [3.1%] vs. 170 patients [1.9%]; hazard ratio, 1.70; 95% CI, 1.40 to 2.05; P<0.001).
• Between these two groups, no significant difference was seen in intracranial or fatal bleeding.
• There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group as compared with 378 (4.1%) in the aspirin-alone group (hazard ratio, 0.82; 95% CI, 0.71 to 0.96; P=0.01; threshold P value for significance, 0.0025).
• The primary outcome did not occur in significantly fewer patients in the rivaroxaban-alone group than in the aspirin-alone group, but major bleeding events occurred in more patients in the rivaroxaban-alone group.