Table 2 Efficacy and safety outcomes for treatment of acute VTE: DOACs versus VKA
Trial Name [Ref] | RE-COVER [15] | RE-COVER II [16] | EINSTEIN-DVT [17] | EINSTEIN-PE [18] | AMPLIFY [19] | Hokusai-VTE [20] |
|---|---|---|---|---|---|---|
Primary Efficacy Outcome DOAC vs VKA (%) | Recurrent symptomatic VTE or related death: 2.4 vs 2.1a | Recurrent symptomatic VTE or related mortality: 2.3 vs 2.2a | Recurrent symptomatic VTE: 2.1 vs 3.0a | Recurrent symptomatic VTE: 2.1 vs 1.8a | Recurrent symptomatic VTE or related mortality: 2.3 vs 2.7a | Recurrent symptomatic VTE or related mortality: 3.2 vs 3.5a |
Primary Safety Outcome(s) | Major bleeding; Major or CRNM bleeding: Any bleeding | Major bleeding Major or CRNM bleeding: Any bleeding | Major or CRNM bleeding | Major or CRNM bleeding | Major bleeding | Major or CRNM bleeding |
Major Bleeding DOAC vs VKA (%) | 1.6 vs 1.9 | 1.2 vs 1.7 | 0.8 vs 1.2 | 1.1a vs 2.2 | 0.6a vs 1.8 | 1.4 vs 1.6 |
Major or CRNM Bleeding DOAC vs VKA (%) | 5.6 vs 8.8 | 5.0 vs 7.9 | 8.1 vs 8.1 | 10.3 vs 11.4 | 4.3a vs 9.7 | 8.5a vs 10.3 |