Table 3.
Adverse Event Rates from Discharge Through 45 ± 14 Days in Mutually-Exclusive Discharge Medication Groupings.
| Adverse Event | Warfarin and Aspirin | Warfarin Only | DOAC and Aspirin | DOAC Only | DAPT | P Value* | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| N | (%) | N | (%) | N | (%) | N | (%) | N | (%) | ||
|
| |||||||||||
| Any adverse event | 626 | (5.72) | 157 | (4.01) | 321 | (5.27) | 134 | (3.83) | 78 | (5.56) | <0.0001 |
| Any major adverse event † | 483 | (4.41) | 130 | (3.32) | 262 | (4.30) | 111 | (3.17) | 60 | (4.28) | 0.0017 |
| Death | 88 | (0.80) | 32 | (0.82) | 52 | (0.85) | 27 | (0.77) | 14 | (1.00) | 0.0205 |
| Ischemic stroke | 16 | (0.15) | 9 | (0.23) | 20 | (0.33) | 7 | (0.20) | 6 | (0.43) | <0.0001 |
| Hemorrhagic stroke | 15 | (0.14) | 1 | (0.03) | 10 | (0.16) | 2 | (0.06) | 2 | (0.14) | <0.0001 |
| Undetermined stroke | 2 | (0.02) | 0 | (0.00) | 0 | (0.00) | 2 | (0.06) | 1 | (0.07) | <0.0001 |
| TIA | 11 | (0.10) | 8 | (0.20) | 6 | (0.10) | 4 | (0.11) | 0 | (0.00) | <0.0001 |
| Intracranial hemorrhage | 9 | (0.08) | 2 | (0.05) | 5 | (0.08) | 2 | (0.06) | 1 | (0.07) | 0.0001 |
| Systemic arterial embolism | 4 | (0.04) | 1 | (0.03) | 0 | (0.00) | 3 | (0.09) | 2 | (0.14) | <0.0001 |
| Major bleeding | 336 | (3.07) | 72 | (1.84) | 172 | (2.83) | 60 | (1.71) | 31 | (2.21) | <0.0001 |
| Major vascular complication | 17 | (0.16) | 9 | (0.23) | 12 | (0.20) | 3 | (0.09) | 1 | (0.07) | <0.0001 |
| Myocardial infarction | 18 | (0.16) | 6 | (0.15) | 7 | (0.11) | 2 | (0.06) | 4 | (0.29) | 0.0022 |
| Pericardial effusion requiring intervention | 24 | (0.22) | 1 | (0.03) | 12 | (0.20) | 6 | (0.17) | 5 | (0.36) | 0.0006 |
| Device embolization | 3 | (0.03) | 3 | (0.08) | 0 | (0.00) | 2 | (0.06) | 0 | (0.00) | 0.0006 |
| Readmission | 616 | (5.62) | 209 | (5.33) | 355 | (5.83) | 176 | (5.03) | 77 | (5.49) | 0.5183 |
| Any stroke or TIA | 43 | (0.39) | 18 | (0.46) | 36 | (0.59) | 15 | (0.43) | 9 | (0.64) | 0.3589 |
| Atrial/device-related thrombus among those with TEE | 187 | (1.85) | 53 | (1.48) | 96 | (1.73) | 58 | (1.82) | 37 | (3.31) | <0.0001 |
| Peri-device Leak >5 mm among those with TEE | 86 | (0.85) | 20 | (0.56) | 34 | (0.61) | 26 | (0.82) | 5 | (0.45) | 0.1940 |
*
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
TEE = transesophageal echocardiography; TIA = transient ischemic attack. Other abbreviations as in Table 1.