TableĀ 3

Observed versus expected events at 12- and 24-month follow-up, adjusted for patient/year

Events12-month (158 patients/year)Global follow-up (annual event rates, 290 patients/year)
ObservedExpected*p ValueObservedExpected*p Value
Death9 (5.8%)17 (5.8%)
Major bleeding8 (5.2%)6.6%
HAS-BLED
0.4009 (3.1%)6.6%
HAS-BLED
0.047
Total bleeding (major+relevant)15 (9.5%)16 (5.5%)
Stroke/TIA6 (3.9%)9.6%
CHADS2
0.0077 (2.4%)9.6%
CHADS2
<0.001
8.3% CHA2DS2-VASc0.0258.3% CHA2DS2-VASc0.003
  • *Expected rates based on Friberg et al9 using event rates not adjusted for reduction by aspirin.

  • HAS-BLED, hypertension, abnormal liver/renal function, stroke history, bleeding predisposition, labile international normalised ratios, elderly, drugs/alcohol use; TIA, transient ischaemic attack.