Table 2.
Number of events, cumulative incidence, log-rank analysis, and hazard ratio (HR) for primary and secondary outcomes.
Number of events | Cumulative incidence | Log rank | P | Adjusted HR (95% CI) | |
---|---|---|---|---|---|
STROKE RECURRENCE | |||||
VKA | 18 | Ref. | |||
FXa | 20 | 0.94 (0.41–2.21) | |||
DTI | 4 | 0.68 (0.18–2.46) | |||
Total | 42 | 17% | 1.07 | 0.58 | |
INTRACRANIAL HEMORRHAGE | |||||
VKA | 2 | Ref. | |||
FXa | 1 | 0.43 (0.03–5.68) | |||
DTI | 1 | 1.45 (0.12–17.08) | |||
Total | 4 | 1.6% | 61 | 0.73 | |
MAJOR BLEEDING | |||||
VKA | 6 | Ref. | |||
FXa | 4 | 1.02 (0.06–15.53) | |||
DTI | 2 | 2.54 (0.17–37.17) | |||
Total | 12 | 4.9% | 0.62 | 0.73 | |
ALL-CAUSE MORTALITY | |||||
VKA | 20 | Ref. | |||
FXa | 25 | 0.44 (0.12–1.66) | |||
DTI | 10 | 0.83 (0.16–4.22) | |||
Total | 55 | 22% | 0.43 | 0.78 | |
CRNMH | |||||
VKA | 15 | Ref. | |||
FXa | 18 | 0.57 (0.15–2.02) | |||
DTI | 4 | 0.49 (0.08–2.78) | |||
Total | 35 | 14.4% | 0.54 | 0.77 | |
MINOR BLEEDING | |||||
VKA | 17 | Ref. | |||
FXa | 7 | 0.53 (0.13–2.16) | |||
DTI | 4 | 0.34 (0.04–2.97) | |||
Total | 28 | 11.6% | 5.77 | 0.057 | |
PERIPHERAL EMBOLISM | |||||
VKA | 2 | Ref. | |||
FXa | 2 | 0.37 (0.01–10.24) | |||
DTI | 2 | 0.55 (0.01–17.23) | |||
Total | 6 | 2.4% | 1.36 | 0.50 |
VKA, vitamin K antagonist; FXa, Factor Xa inhibitor; DTI, direct thrombin inhibitor; CRNNMH, clinically relevant nonmajor hemorrhage. Cox regression analysis adjusted by sex, age, Charlson comorbidity index, and previous stroke.