Table 3.
Clinical Outcomes at 1 Year by Country/Region
| Outcomes at 1 year, n (annual incidence, %) [95% CI] |
Total (N=3,359) |
South Korea (n=1,887) |
Taiwan (n=983) |
Hong Kong (n=190) |
Thailand (n=299) |
P value* |
|---|---|---|---|---|---|---|
| All-cause death | 58 (1.78) [1.38; 2.31] |
16 (0.87) [0.54; 1.43] |
21 (2.19) [1.43; 3.36] |
10 (5.45) [2.93; 10.12] |
11 (3.90) [2.16; 7.03] |
<0.0001* |
| CV death | 22 (0.68) [0.45; 1.03] |
9 (0.49) [0.26; 0.94] |
6 (0.63) [0.28; 1.39] |
3 (1.63) [0.53; 5.07] |
4 (1.42) [0.53; 3.77] |
0.2 |
| Hemorrhagic stroke | 9 (0.28) [0.14; 0.53] |
5 (0.27) [0.11; 0.66] |
2 (0.21) [0.05; 0.84] |
2 (1.09) [0.27; 4.38] |
0 [0.00; NE] |
0.3 |
| Ischemic stroke | 37 (1.14) [0.83; 1.58] |
17 (0.93) [0.58; 1.50] |
11 (1.16) [0.64; 2.09] |
1 (0.55) [0.08; 3.88] |
8 (2.85) [1.43; 5.70] |
0.06 |
| SEEs | 1 (0.03) [0.00; 0.22] |
0 [0.00; NE] |
0 [0.00; NE] |
0 [0.00; NE] |
1 (0.36) [0.05; 2.52] |
1.0 |
| Major bleeding (ISTH) | 43 (1.33) [0.99; 1.79] |
18 (0.99) [0.62; 1.57] |
13 (1.37) [0.79; 2.35] |
7 (3.88) [1.85; 8.14] |
5 (1.78) [0.74; 4.29] |
0.02* |
| Major GI bleeding | 18 (0.55) [0.35; 0.88] |
5 (0.27) [0.11; 0.66] |
5 (0.52) [0.22; 1.26] |
3 (1.64) [0.53; 5.10] |
5 (1.78) [0.74; 4.29] |
0.01* |
| Intracranial hemorrhage | 12 (0.37) [0.21; 0.65] |
5 (0.27) [0.11; 0.66] |
4 (0.42) [0.16; 1.11] |
3 (1.65) [0.53; 5.12] |
0 [0.00; NE] |
0.1 |
| Major or CRNM bleeding | 70 (2.18) [1.72; 2.75] |
26 (1.43) [0.97; 2.10] |
23 (2.44) [1.62; 3.66] |
11 (6.23) [3.45; 11.24] |
10 (3.60) [1.94; 6.69] |
0.0004* |
| Net clinical outcome† | 132 (4.11) [3.47; 4.88] |
50 (2.77) [2.10; 3.65] |
44 (4.66) [3.46; 6.26] |
15 (8.34) [5.03; 13.84] |
23 (8.29) [5.51; 12.47] |
<0.0001* |
*Significant P values indicate a significant effect of the region (based on Wald test). †All strokes, SEEs, myocardial infarctions, major bleeding (ISTH), and all-cause death. CI, confidence interval; CRNM, clinically relevant nonmajor; CV, cardiovascular; GI, gastrointestinal; ISTH, International Society on Thrombosis and Haemostasis; NE, not estimable; SEE, systemic embolic event.