Table 4.
Adverse Event | Warfarin and Aspirin Only | Warfarin Only | DOAC and Aspirin Only | DOAC Only | DAPT Only | P Value* | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
N | (%) | N | (%) | N | (%) | N | (%) | N | (%) | ||
| |||||||||||
Any adverse event | 1157 | (10.27) | 346 | (8.54) | 567 | (9.07) | 300 | (8.29) | 134 | (9.14) | 0.0006 |
Any major adverse event † | 1090 | (9.67) | 347 | (8.57) | 554 | (8.87) | 290 | (8.02) | 137 | (9.35) | 0.0211 |
Death | 384 | (3.41) | 143 | (3.53) | 200 | (3.20) | 106 | (2.93) | 63 | (4.30) | 0.1383 |
Ischemic stroke | 59 | (0.52) | 28 | (0.69) | 42 | (0.67 | 24 | (0.66) | 10 | (0.68) | 0.0002 |
Hemorrhagic stroke | 29 | (0.26) | 8 | (0.20) | 18 | (0.29) | 9 | (0.25) | 3 | (0.20) | 0.0037 |
Undetermined stroke | 4 | (0.04) | 0 | (0.00) | 1 | (0.02) | 3 | (0.08) | 1 | (0.07) | 0.0006 |
TiA | 33 | (0.29) | 16 | (0.39) | 29 | (0.46) | 13 | (0.36) | 5 | (0.34) | 0.0004 |
Intracranial hemorrhage | 29 | (0.26) | 3 | (0.07) | 17 | (0.27) | 9 | (0.25) | 4 | (0.27) | 0.0008 |
Systemic arterial embolism | 21 | (0.19) | 9 | (0.22) | 12 | (0.19) | 15 | (0.41) | 6 | (0.41) | <.0001 |
Major bleeding | 560 | (4.97) | 154 | (3.80) | 272 | (4.35) | 120 | (3.32) | 49 | (3.34) | 0.0005 |
Major vascular complication | 26 | (0.23) | 10 | (0.25) | 16 | (0.26) | 3 | (0.08) | 2 | (0.14) | 0.0029 |
Myocardial infarction | 49 | (0.43) | 11 | (0.27) | 17 | (0.27) | 12 | (0.33) | 11 | (0.75) | 0.0052 |
Pericardial effusion requiring intervention | 38 | (0.34) | 2 | (0.05) | 16 | (0.26) | 8 | (0.22) | 5 | (0.34) | 0.0068 |
Device embolization | 3 | (0.03) | 3 | (0.07) | 0 | (0.00) | 2 | (0.06) | 0 | (0.00) | 0.0159 |
Readmission | 1,608 | (14.27) | 520 | (12.84) | 901 | (14.42) | 498 | (13.76) | 194 | (13.23) | 0.1355 |
Any stroke or TIA | 122 | (1.08) | 51 | (1.26) | 88 | (1.41) | 47 | (1.30) | 19 | (1.30) | 0.4226 |
P values for comparisons across all groups.
Major adverse events were defined as death, myocardial infarction, pericardial effusion requiring intervention, systemic embolism, device embolization, major vascular complication, hemorrhagic stroke, ischemic stroke, undetermined stroke, TIA, intracranial hemorrhage, or major bleeding