Table 4

Types and Frequencies of Major Bleeding Events That Occurred After the Period of Adjunctive Pharmacotherapy (OAC and DAPT) in the Device Group (>6 Months Post-Randomization)

LAA Closure
(n = 732)
Warfarin
(n = 382)
p Value
Gastrointestinal bleeding10 (1.4)21 (5.5)<0.001
Epistaxis1 (0.1)1 (0.3)1.0
Hematuria0 (0)2 (0.5)0.12
Hemorrhagic stroke2 (0.3)7 (1.8)0.01
Cranial bleed3 (0.4)1 (0.3)1.0
Anemia requiring transfusion2 (0.3)1 (0.3)1.0
Major bleed requiring transfusion1 (0.1)1 (0.3)1.0
Other bleeding0 (0)1 (0.3)0.35

Values are n (%). Note that patients were randomly assigned to LAA closure or warfarin therapy in a 2:1 fashion.

DAPT = dual antiplatelet therapy; LAA = left atrial appendage; OAC = oral anticoagulation.