Table 4.
Clinical Outcomes at 1 Year Stratified by Edoxaban Dose
| Outcomes at 1 year, n (annual incidence, %) [95% CI] |
Total (N=3,359) |
Patients without dose-reduction criteria |
Patients with ≥1 dose-reduction criterion |
P value* | ||
|---|---|---|---|---|---|---|
| Recommended 60 mg (n=1,293) |
Nonrecommended 30 mg (n=601) |
Recommended 30 mg (n=1,088) |
Nonrecommended 60 mg (n=377) |
|||
| All-cause death | 58 (1.78) [1.38; 2.31] |
9 (0.71) [0.37; 1.37] |
11 (1.88) [1.04; 3.40] |
32 (3.07) [2.17; 4.34] |
6 (1.64) [0.74; 3.64] |
0.001* |
| CV death | 22 (0.68) [0.45; 1.03] |
7 (0.55) [0.26; 1.16] |
3 (0.51) [0.17; 1.59] |
12 (1.15) [0.65; 2.03] |
0 [0.00; NE] |
0.4 |
| Hemorrhagic stroke | 9 (0.28) [0.14; 0.53] |
3 (0.24) [0.08; 0.74] |
2 (0.34) [0.09; 1.37] |
4 (0.38) [0.14; 1.02] |
0 [0.00; NE] |
0.9 |
| Ischemic stroke | 37 (1.14) [0.83; 1.58] |
13 (1.04) [0.60; 1.79] |
8 (1.38) [0.69; 2.76] |
13 (1.25) [0.73; 2.16] |
3 (0.82) [0.26; 2.54] |
0.8 |
| SEEs | 1 (0.03) [0.00; 0.22] |
0 [0.00; NE] |
0 [0.00; NE] |
1 (0.10) [0.01; 0.68] |
0 [0.00; NE] |
1.0 |
| Major bleeding (ISTH) | 43 (1.33) [0.99; 1.79] |
16 (1.28) [0.78; 2.08] |
6 (1.03) [0.46; 2.30] |
18 (1.74) [1.10; 2.76] |
3 (0.82) [0.26; 2.55] |
0.5 |
| Major GI bleeding | 18 (0.55) [0.35; 0.88] |
5 (0.40) [0.17; 0.95] |
1 (0.17) [0.02; 1.22] |
9 (0.87) [0.45; 1.67] |
3 (0.82) [0.26; 2.55] |
0.3 |
| Intracranial hemorrhage | 12 (0.37) [0.21; 0.65] |
4 (0.32) [0.12; 0.85] |
2 (0.34) [0.09; 1.37] |
6 (0.58) [0.26; 1.29] |
0 [0.00; NE] |
0.8 |
| Major or CRNM bleeding | 70 (2.18) [1.72; 2.75] |
25 (2.00) [1.35; 2.96] |
8 (1.38) [0.69; 2.76] |
30 (2.93) [2.05; 4.19] |
7 (1.93) [0.92; 4.05] |
0.2 |
| Net clinical outcome† | 132 (4.11) [3.47; 4.88] |
33 (2.65) [1.88; 3.72] |
27 (4.71) [3.23; 6.86] |
60 (5.85) [4.54; 7.53] |
12 (3.30) [1.87; 5.80] |
0.003* |
*Significant P values indicate a significant effect of dose recommendation (recommended 60 mg, nonrecommended 30 mg, recommended 30 mg, nonrecommended 60 mg) based on Wald test. †All strokes, SEEs, myocardial infarctions, major bleeding (ISTH), and all-cause death. Abbreviations as in Table 3.