Over a mean follow-up of 23 months, there was a marked decrease in the primary composite end point of cardiovascular death, stroke, or myocardial infarction in the combination therapy group by 24% (hazard ration [HR] 0.76; 95% CI 0.66-0.86; p<0.001) over aspirin monotherapy, and improved survival by 18%. The trial terminated prematurely by the data monitoring committee due to due to overwhelming efficacy. Rivaroxaban monotherapy showed no efficacy benefit.
The anticipated trade-off was apparent with increased major bleeding in the combination therapy arm (HR 1.70, 95% CI 1.40–2.05; p<0.001), although fatal and intracranial bleeds wer