Table 4.
Risk of bleeding in RCTs of extended VTE treatment with DOACs
| Dabigatran | Rivaroxaban | Apixaban | |||||
|---|---|---|---|---|---|---|---|
| RE-MEDY (versus VKA) [35] | RE-SONATE (versus placebo) [35] | EINSTEIN-EXT (versus placebo) [18] | EINSTEIN-CHOICE (versus ASA 100 mg) [36] | AMPLIFY-EXT (versus placebo) [37] | |||
| 150 mg | 150 mg | 20 mg | 20 mg | 10 mg | 5 mg | 2.5 mg | |
| Recurrent VTE | = | ↓ | ↓ | ↓ | ↓ | ↓ | ↓ |
| MB or CRNM | ↓ | ↑ | ↑ | = | = | = | = |
| MB | = | – | – | = | = | = | = |
| GIB | – | – | – | – | – | – | – |
| ICH | – | – | – | – | – | – | – |
ASA aspirin, 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, VKA vitamin k antagonist, VTE venous thromboembolism
Symbols: = similar; ↓ minor; ↑ higher [hazard ratio (HR) of events with DOACs versus warfarin]; – no data