Table 3

Observed Rates of Major Bleeding Over Time According to Treatment Group

LAA Closure
(n = 732)
Long-Term Warfarin
(n = 382)
Rate Ratio (95% CI)p Value
Bleeding Rate (n events/N at risk)Event Rate/100 pt-yrs (n events/pt-years)Bleeding Rate (n events/N at risk)Event Rate/100 pt-yrs (n events/pt-years)
Overall10.8 (79/732)3.5 (79/2,268)11.3 (43/382)3.6 (43/1,187)0.96 (0.66–1.40)0.84
Post-procedural5.9 (40/682)1.8 (40/2,255)11.3 (43/381)3.6 (43/1,180)0.49 (0.32–0.75)0.001
Destination therapy3.2 (19/601)1.0 (19/1,958)9.7 (35/360)3.5 (35/1,004)0.28 (0.16–0.49)<0.001

Values are % (n/N). The overall period was defined as after randomization to the end of follow-up; post-procedural period as >7 days after randomization to the end of follow-up, thereby isolating nonprocedural related bleeding events; and destination therapy period as beyond 180 days post-randomization, when patients assigned to LAA closure were eligible to receive aspirin alone. Patients were randomized in a 2:1 fashion to either LAA closure or long-term warfarin.

LAA = left atrial appendage; Pt-yrs = patient-years.