Table 4. Annualized event rates for clinical outcomes in the higher-dose edoxaban, lower-dose edoxaban, and warfarin arms stratified by ABC-stroke and ABC-bleeding risk scores.
1-year Risk of Bleeding Predicted by ABC-Bleeding Model | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
< 1 % | 1–2 % | > 2 % | |||||||||
LDER | HDER | WAR | LDER | HDER | WAR | LDER | HDER | WAR | |||
1-year Risk of S/SEE
Predicted by ABC-Stroke Model |
<1% | N | 175 | 195 | 208 | 390 | 386 | 388 | 269 | 237 | 239 |
Stroke/SEE | 0.43 | 0.77 | 0.18 | 0.38 | 0.78 | 0.87 | 1.26 | 0.48 | 1.09 | ||
Bleeding | 0.48 | 0.42 | 0.59 | 0.84 | 1.61 | 1.89 | 1.46 | 2.44 | 3.50 | ||
NCO | 1.43 | 1.48 | 1.38 | 1.67 | 2.80 | 2.64 | 2.44 | 3.57 | 4.25 | ||
1–2% | N | 18 | 28 | 19 | 307 | 308 | 322 | 884 | 904 | 844 | |
Stroke/SEE | 0.00 | 2.84 | 2.02 | 1.11 | 1.62 | 0.97 | 1.91 | 1.16 | 1.66 | ||
Bleeding | 0.00 | 0.00 | 2.19 | 0.96 | 1.58 | 2.18 | 2.17 | 3.68 | 4.05 | ||
NCO | 0.00 | 4.71 | 2.19 | 2.35 | 3.59 | 4.12 | 4.86 | 5.62 | 5.96 | ||
>2% | N | 1 | 3 | 3 | 47 | 29 | 52 | 737 | 732 | 739 | |
Stroke/SEE | 0.00 | 0.00 | 0.00 | 2.68 | 2.77 | 4.62 | 3.58 | 2.92 | 3.21 | ||
Bleeding | 0.00 | 0.00 | 0.00 | 3.14 | 0.00 | 0.86 | 3.85 | 4.83 | 5.85 | ||
NCO | 0.00 | 0.00 | 0.00 | 4.18 | 4.91 | 5.30 | 9.22 | 8.31 | 10.91 |
The net clinical outcome is a composite of stroke, systemic embolic event, major bleeding, and all-cause mortality. HDER indicates high-dose edoxaban regimen; LDER, low-dose edoxaban regimen; NCO, net clinical outcome; S/SEE, stroke or systemic embolic event; WAR, warfarin.