Table 3. Results of ARISTOTLE, RE-LY, and ROCKET-AF trials according to subgroup.
Trial Name, Year | Group | Outcome | Heart failure (Yes/No) | Previous stroke-TIA (Yes/No) | CrCl (<50 mL/min 50–80 mL/min >80 mL/min) | CHADS2 score | Age (>75 years/<75 years) | Diabetes mellitus (Yes/No) | Prior VKA useNaïve VKA patients |
RELY, 2009 | D 110 mg bid | SSE | HR 0.99 (0.69–1.42) HR 0.86 (0.67–1.09) | 55/1195 128/4819 | HR 0.89 (0.61–1.31) HR 0.91 (0.68–1.20) HR 0.83 (0.52–1.32) | 0–1 42/19582 59/2088 >2 82/1968 | HR 0.88 (0.66–1.17) HR 0.93 (0.70–1.22) | HR 0.74 (0.51–1.08) HR 0.97 (0.76–1.23) | 94/3011 89/3004 |
MB | HR 0.83 (0.64–1.09) HR 0.79 (0.67–0.94) | 65/1195 277/4819 | 120/1151 154/2714 57/1899 | 0–1 74/1958 2 121/2088 >2 147/1968 | 204/2349 138/3666 | 96/1177 246/4837 | 166/3011 176/3004 | ||
D 150 mg bid | SSE | HR 0.75 (0.51–1.10) HR 0.61 (0.47–0.79) | 51/1233 83/4843 | HR 0.47 (0.30–0.74) HR 0.65 (0.47–0.88) HR 0.71 (0.44–1.15) | 0–1 26/1958 2 35/2137 >2 73/1981 | HR 0.67 (0.49–0.90) HR 0.63 (0.46–0.86) | HR 0.62 (0.42–0.91) HR 0.66 (0.51–0.88) | 73/3049 61/3026 | |
MB | HR 0.79 (0.60–1.03) HR 0.99 (0.84–1.16) | 102/1233 297/4843 | 123/1188 182/2777 80/1882 | 0–1 84/1958 2 127/2137 >2 188/1981 | 246/2466 153/3610 | 117/1124 282/4952 | 209/3049 190/3026 | ||
VKA | SSE | - | 65/1195 137/4827 | - | 0–1 40/1859 2 60/2230 >2 102/1933 | - | - | 105/2929 97/3093 | |
MB | - | 97/1195 324/4827 | 112/1081 206/2806 94/1887 | 0–1 105/1859 2 144/2230 >2 172/1933 | 206/2423 215/3599 | 102/1195 319/4827 | 216/2929 205/3093 | ||
R 15 or 20 mg od | SSE | 160/4438 109/2642 | 187/3892 82/3189 | 77/1490 126/3298 65/2285 | 2 30/924 >2 239/6156 | 125/3082 144/3999 | 95/2851 174/4230 | 168/4413 101/2668 | |
ROCKET, 2010 | MB | 106/4428 83/2632 | 136/3881 53/3180 | 50/1485 91/3290 47/2278 | 2 21/922 >2 168/6138 | 82/3073 107/3988 | 70/2842 119/4219 | 114/4401 75/2660 | |
VKA | SSE | 172/4413 134/2676 | 190/3875 116/3215 | 86/1459 151/3400 68/2222 | 2 36/933 >2 270/6155 | 154/3082 152/4008 | 114/2796 192/4294 | 175/4440 131/2650 | |
MB | 141/4409102/2672 | 151/386992/3213 | 60/1456 128/3396 54/2221 | 2 24/931>2 219/6149 | 124/3077119/4005 | 94/2793149/4289 | 140/4437103/2645 | ||
A 2.5 or 5 mg bid | SSE | 70/3235 142/5885 | 73/1748 139/7372 | 54/1502 87/3817 70/3761 | 0–1 44/3100 2 74/3262 >2 94/2758 | 79/2850 133/6270 | 57/2284 155/6836 | 102/5208 110/3912 | |
ARISTOTLE, 2011 | MB | 87/3235 240/5885 | 77/1748 250/7372 | 73/1502 157/3817 96/3761 | 0–1 76/3100 2 125/3262 >2 126/2758 | 151/2850 176/6270 | 112/2284 215/6836 | 185/5208 142/3912 | |
VKA | SSE | 79/3216 186/5865 | 98/1790 167/7291 | 69/1515 116/3770 79/3757 | 0–1 51/3083 2 82/3254 >2 132/2744 | 109/2828 156/6253 | 75/2263 190/6818 | 138/5193 127/3888 | |
MB | 137/3216 325/5865 | 106/1790 356/7291 | 142/1515 199/3770 119/3757 | 0–1 126/3083 2 163/3254 >2 173/2744 | 224/2828 238/6253 | 114/2263 348/6818 | 274/5193 188/3888 |
A: apixaban; Bid: twice daily; D: dabigatran; HR: hazard ratio; MB: major bleeding; NR: not reported; od: once daily; R: rivaroxaban; SE: systemic embolism; SSE: stroke and/or systemic embolism; TIA: transient ischemic attack; VKA: vitamin K antagonist.