Table 3.
Risk of bleeding with DOACs versus Warfarin in RCTs and real-world studies on acute treatment of VTE
| RCTs | ||||
|---|---|---|---|---|
| Dabigatran | Rivaroxaban | Apixaban | Edoxaban | |
| RE-COVER (150 mg) [17] | EINSTEIN DVT-PE [18–20] | AMPLIFY [21] | Hokusai-VTE [22] | |
| Recurrent VTE | = | = | = | = |
| MB or CRNMB | ↓ | = | ↓ | ↓ |
| MB | = | ↓ | ↓ | = |
| ICH | ↓* | ↓* | ↓* | ↓* |
| MGIB | ↑* | =* | ↓* | =* |
| Real-world data | ||||
|---|---|---|---|---|
| Dabigatran [23–25] | Rivaroxaban [23, 24, 26–28] | Apixaban [24, 28–31] | Edoxaban | |
| Recurrent VTE | = | = | =↓ | – |
| CRNMB | = | – | ↓ | – |
| MB | = | = | ↓ | – |
| ICH | – | ↓ | =↓ | – |
| GIB | = | = | ↓ | – |
CRNMB clinically relevant non-major bleeding, GIB gastrointestinal bleeding, ICH intracerebral hemorrhage, MB major bleeding, MGIB major gastrointestinal bleeding, NVAF non-valvular atrial fibrillation, SE systemic embolism, VTE venous thromboembolism
Symbols: = similar; ↓ minor; ↑ higher [hazard ratio (HR) of events with DOACs versus warfarin]; – no data
*Only the number of cases/frequency was reported but not HR and/or statistical significance