Table 2.
Adjudicated clinical endpoints at 24 and 48 weeks of follow-up
| Endpoint | 24 weeks | 24–48 weeks | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Apixaban, AEP (N = 583) | Apixaban, pSOC (N = 579) | Apixaban, AEP (N = 261) | Apixaban, pSOC (N = 583) | Apixaban, sSOC (N = 263) | ||||||
| Patients | Events | Patients | Events | Patients | Events | Patients | Events | Patients | Events | |
| Death | 4 (0.7) | 4 | 4 (0.7) | 4 | 1 (0.4) | 1 | 1 (0.2) | 1 | 3 (1.1) | 3 |
| Cardiovascular death | 2 (0.3) | 2 | 4 (0.7) | 4 | 0 | 0 | 1 (0.2) | 1 | 2 (0.8) | 2 |
| Stroke, TIA, SE | 5 (0.9) | 6 | 1 (0.2) | 1 | 1 (0.4) | 1 | 1 (0.2) | 1 | 3 (1.1) | 3 |
| Ischemic stroke | 0 | 0 | 1 (0.2) | 1 | 1 (0.4) | 1 | 0 | 0 | 0 | 0 |
| Hemorrhagic stroke | 2 (0.3) | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.4) | 1 |
| TIA | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.2) | 1 | 1 (0.4) | 1 |
| SE | 3 (0.5) | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.4) | 1 |
| Myocardial infarction | 4 (0.7) | 4 | 2 (0.3) | 2 | 0 | 0 | 1 (0.2) | 1 | 0 | 0 |
| Venous thromboembolism | 1 (0.2)a | 1 | 0 | 0 | 1 (0.4) | 1 | 0 | 0 | 0 | 0 |
| Pulmonary embolism | 1 (0.2) | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Deep vein thrombosis | 1 (0.2) | 1 | 0 | 0 | 1 (0.4) | 1 | 0 | 0 | 0 | 0 |
| MB (non-fatal) or CRNMB | 9 (1.6)b | 10 | 7 (1.2) | 7 | 0 | 0 | 2 (0.3) | 2 | 2 (0.8) | 2 |
| MB (non-fatal) | 4 (0.7) | 4 | 2 (0.3) | 2 | 0 | 0 | 2 (0.3) | 2 | 1 (0.4) | 1 |
| CRNMB | 5 (0.9) | 5 | 5 (0.9) | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
| Fatal bleeding | 1 (0.2) | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.4) | 1 |
AEP additional educational program, CRNMB clinically relevant non-major bleeding, MB major bleeding, pSOC primary standard of care, SE systemic embolism, sSOC secondary standard of care, TIA transient ischemic attack
Data are presented as N or N (%)
aOne patient, who had one event of deep vein thrombosis + pulmonary embolism
bOne patient had a major and fatal bleeding