Table 5: Comparison of observed events with predicted events (N = 78).

Events (per 100 patients/year)* Observed Predicted Reduction p-value
Death 19 (9.1%)
Severe/significant bleeding 14 (6.7%) 7.7% (HAS-BLED) (-13%) 0.389
Stroke 5 (2.4%) 10.0% (CHADS2)

(-73%)

5.9%

(-59%)

< 0.001
9.0% (CHA2DS2-VASc)

(-76%)

6.7%

(-64%)

< 0.001

*Overall follow-up: 32.2 months (209 patients/year).