Table 1. Baseline characteristics and corresponding primary efficacy outcomes of the Phase 3 trials included.
| NVAF Studies | |||||||
|---|---|---|---|---|---|---|---|
| Study | Publication Year | DOAC and dosing regimen | Primary Events /Total N | Comparator | Primary Events /Total N | Age Years | Women % |
| RE-LY | 2009 | Dabigatran 150mg twice daily | 182/6015 | Warfarin | 199/6022 | 71.6 | 36.8 |
| ARISTOTLE | 2011 | Apixaban 5mg twice daily | 212/9120 | Warfarin | 265/9081 | 70.0 | 35.2 |
| ROCKET AF | 2011 | Rivaroxaban 20mg daily | 188/6958 | Warfarin | 241/7004 | 73.0 | 39.7 |
| ENGAGE AF- TIMI 48 | 2013 | Edoxaban 60mg daily | 296/7035 | Warfarin | 337/7036 | 72.0 | 37.7 |
| VTE Studies | |||||||
| RE-COVER | 2009 | Dabigatran 150mg twice daily | 30/1274 | Warfarin | 27/1265 | 55.5 | 41.6 |
| EINSTEIN-DVT | 2010 | Rivaroxaban 15mg twice daily for 3 weeks, followed by 20mg daily | 36/1731 | Enoxaparin followed by VKA | 51/1718 | 56.1 | 43.2 |
| AMPLIFY | 2013 | Apixaban 10mg twice daily for 7 days, followed by 5mg twice daily | 59/2609 | Subcu. enoxaparin followed by warfarin | 71/2635 | 57.0 | 41.3 |
| Hokusai-VTE | 2013 | Edoxaban 60mg daily | 130/4118 | Warfarin | 146/4122 | 55.8 | 42.7 |
| RE-COVER II | 2014 | Dabigatran 150mg twice daily | 30/1279 | Warfarin | 28/1289 | 56.5 | 39.4 |