Table 2.
Study characteristics
| Study | Treatment | Sample size (n) | Follow-up (years) |
Primary end points | All strokes (n) |
Ischemic stroke (n) |
Myocardial infarction (n) |
Overall mortality (n) |
Major bleeding (n) |
Intracranial hemorrhage (n) |
|---|---|---|---|---|---|---|---|---|---|---|
| ACTIVE-A18 | ASA + C | 3,772 | 3.28 | S, SE, MI, VD | 296 | 235 | 90 | 825 | 251 | 54 |
| ASA | 3,782 | 3.24 | 408 | 343 | 115 | 841 | 162 | 29 | ||
| ACTIVE-W6 | ASA + C | 3,335 | 1.25 | S, SE, MI, VD | 100 | 90 | 36 | 159 | 101 | 21 |
| Warfarin | 3,371 | 1.25 | 59 | 42 | 23 | 158 | 93 | 11 | ||
| AFASAK19 | ASA | 336 | 1.08 | S, TIA, SE | 15 | NR | NR | NR | 2 | NR |
| Placebo | 336 | 1.13 | 16 | NR | NR | NR | 0 | 0 | ||
| AFASAK 220,21 | ASA | 169 | 2.16 | S, SE | 9 | 5 | 4 | 14 | 5 | 1 |
| Warfarin | 170 | 2.09 | 10 | 4 | 4 | 17 | 4 | 2 | ||
| ARISTOTLE22,* | Apixaban | 9,088 | 1.69 | S, SE, MB | 199 | 149 | 90 | 603 | 327 | 52 |
| Warfarin | 9,025 | 1.65 | 250 | 155 | 102 | 669 | 462 | 122 | ||
| AVERROES9 | Apixaban | 2,808 | 1.1 | S or SE | 49 | 35 | 24 | 111 | 44 | 11 |
| ASA | 2,791 | 1.1 | 105 | 93 | 28 | 140 | 39 | 13 | ||
| BAFTA23 | ASA | 485 | 2.7 | Disabling S, | 44 | 32 | 15 | 108 | 25 | 6 |
| Warfarin | 488 | 2.7 | ICH, AE | 21 | 10 | 15 | 107 | 25 | 8 | |
| CAFA24 | Placebo | 191 | 1.27 | Non-lacunar | 9 | 9 | NR | 8 | 2 | 0 |
| Warfarin | 187 | 1.27 | IS, SE, ICH, fatal bleeding | 7 | 6 | NR | 10 | 5 | 1 | |
| EAFT25 | ASA | 404 | 2.07 | VD, non-fatal | 88 | 64 | NR | 102 | 6 | 2 |
| Placebo | 378 | 1.89 | S, non-fatal MI, SE | 90 | 73 | NR | 99 | 4 | 1 | |
| ENGAGE-AF26,^ | Edoxaban HD | 7,035 | 2.19 | S, SE | 281 | 236 | 133 | 773 | 418 | 61 |
| Edoxaban LD | 7,034 | 2.24 | 360 | 233 | 169 | 737 | 254 | 41 | ||
| Warfarin | 7,036 | 2.21 | 317 | 235 | 141 | 839 | 425 | 132 | ||
| JAST27 | ASA | 426 | 2.1 | CVD, IS, TIA | 21 | 17 | NR | 10 | 7 | 4 |
| Placebo | 445 | 2.1 | 20 | 18 | NR | 9 | 2 | 2 | ||
| LASAF33 | ASA | 104 | 1.64 | CVD, OD | 4 | NR | NR | 7 | NR | NR |
| Placebo | 91 | 1.48 | 3 | NR | NR | 9 | NR | NR | ||
| RE-LY7,‡ | Dabigatran 110 | 6,015 | 2 | S, SE | 171 | 152 | 98 | 446 | 342 | 27 |
| Dabigatran 150 | 6,076 | 2 | 122 | 103 | 97 | 438 | 399 | 38 | ||
| Warfarin | 6,022 | 2 | 186 | 134 | 75 | 487 | 421 | 90 | ||
| ROCKET-AF8,§ | Rivaroxaban | 7,111 | 1.57 | S, SE, MB, | 184# | 149# | 101 | 582 | 395 | 55 |
| Warfarin | 7,125 | 1.58 | non-MB (clinically relevant) | 221# | 161# | 126 | 632 | 386 | 84 | |
| SPAF I31 | ASA | 552 | 1.3 | IS, SE | 24 | 23 | 7 | 39 | 10 | 2 |
| Placebo | 568 | 1.29 | 42 | 42 | 12 | 50 | 14 | 2 | ||
| WASPO32 | ASA | 39 | 1 | OD, S, SE, | 0 | 0 | NR | 2 | 3 | 0 |
| Warfarin | 36 | 1 | TIA, MB, withdrawal | 0 | 0 | NR | 1 | 0 | 0 |
Notes:
Sample sizes those used in efficacy analysis (sample sizes used in safety analysis 9,120 and 9,081 for apixaban and warfarin, respectively);
sample sizes those used in efficacy analysis (sample sizes used in safety analysis 7,012, 7,002, and 7,012 for edoxaban HD, edoxaban LD, and warfarin, respectively);
data updated to include new events reported in trial briefing document;
sample sizes those used in the analysis of all efficacy outcomes, except for overall mortality (7,081 and 7,090 for rivaroxaban and warfarin, respectively; sample sizes used in safety analysis 7,061 and 7,082 for rivaroxaban and warfarin, respectively);
data retrieved from supplementary appendix to trial.
Abbreviations: ASA, acetylsalicylic acid (aspirin); C, clopidogrel; LD, low dose; HD, high dose; S, stroke (including ischemic and hemorrhagic); SE, systemic embolism; MI, myocardial infarction; VD, vascular death; TIA, transient ischemic attack; MB, major bleeding; IS, ischemic stroke; ICH, intracranial hemorrhage; AE, arterial embolism; CVD, cardiovascular death; OD, overall death; NR, not reported.