The greatest risk reduction of stroke or systemic embolism was seen with dabigatran 150mg twice daily (odds ratio [OR] 0.65, 95% CI: 0.52-0.81), followed by apixaban 5mg twice daily (OR 0.79, 95% CI: 0.66-0.94).
While death from pulmonary embolism (PE) while watching TV may be a rare event, previous studies have demonstrated a positive association between time watching TV and the risk of death from PE (double the risk for >5hrs per day).
Both doses of Xarelto (10mg and 20mg) were superior to aspirin (100mg) in lowering the risk of recurrent VTE after ≥6 months of standard anticoagulation.
The new sNDA submission is supported by the 'Einstein Choice' study, which included 3,365 patients in a Phase 3 randomized, double-blind study that compared Xarelto once daily to aspirin.