Table 2.
Unadjusted Cumulative Incidence Rates of Primary Effectiveness and Safety Outcomes at One-year Follow-up, Stratified by History of Stroke or Transient Ischemic Attack, by Treatment Group
| No History of Stroke or TIA | ||||
|---|---|---|---|---|
| Apixaban (n=1864) | Dabigatran (n=1168) | Rivaroxaban (n=4035) | Warfarin (n=9271) | |
| Effectiveness Outcomes | ||||
| Ischemic Stroke | ||||
| Number of events | 106(5.69%) | 95(8.13%) | 281(6.96%) | 787(8.49%) |
| Cumulative incidence at 1 year | 0.10(0.08,0.12) | 0.10(0.08,0.13) | 0.10(0.09,0.11) | 0.11(0.11,0.12) |
| Other Thromboembolic Event | ||||
| Number of events | 36(1.93%) | 37(3.17%) | 133(3.3%) | 723(7.80%) |
| Cumulative incidence at 1 year | 0.03(0.02,0.04) | 0.04(0.02,0.05) | 0.04(0.03,0.05) | 0.09(0.09,0.10) |
| Safety Outcomes | ||||
| Any Bleeding Event | ||||
| Number of events | 219(11.75%) | 203 (17.38%) | 814 (20.17%) | 1868(20.15%) |
| Cumulative incidence at 1 year | 0.20(0.17,0.23) | 0.21(0.18,0.24) | 0.27(0.25,0.28) | 0.26(0.25,0.27) |
| GI Bleeding | ||||
| Number of events | 64(3.43%) | 58(4.97%) | 314(7.78%) | 617(6.66%) |
| Cumulative incidence at 1 year | 0.06(0.04,0.07) | 0.06(0.05,0.08) | 0.10(0.09,0.12) | 0.09(0.08,0.10) |
| History of Stroke or TIA | ||||
| Apixaban (n=494) | Dabigatran (n=247) | Rivaroxaban (n=1104) | Warfarin (n=3082) | |
| Effectiveness Outcomes | ||||
| Ischemic Stroke | ||||
| Number of events | 124(25.10%) | 52(21.05%) | 265(24.00%) | 942(30.56%) |
| Cumulative incidence at 1 year | 0.37(0.30,0.44) | 0.27(0.20,0.34) | 0.32(0.28,0.35) | 0.38(0.35,0.40) |
| Other Thromboembolic Event | ||||
| Number of events | 32(6.48%) | 19(7.69%) | 107(9.69%) | 385(12.49%) |
| Cumulative incidence at 1 year | 0.12(0.07,0.16) | 0.10(0.05,0.15) | 0.12(0.10,0.15) | 0.16(0.14,0.17) |
| Safety Outcomes | ||||
| Any Bleeding Event | ||||
| Number of events | 65(13.16%) | 55(22.27%) | 230 (20.83%) | 719(23.33%) |
| Cumulative incidence at 1 year | 0.21(0.16,0.27) | 0.27(0.20,0.34) | 0.29(0.25,0.33) | 0.29(0.27,0.31) |
| GI Bleeding | ||||
| Number of events | 19(3.85%) | 24(9.72%) | 93(8.42%) | 252(8.18%) |
| Cumulative incidence at 1 year | 0.05(0.03,0.08) | 0.13(0.08,0.18) | 0.12(0.10,0.15) | 0.11(0.09,0.12) |
Abbreviations: TIA=Transient Ischemic Attack; GI= gastrointestinal.
Cumulative incidence of effectiveness and safety outcomes were calculated from Kaplan-Meier curves. Number of events are presented as frequency and percentage of the respective treatment group. Cumulative incidence at 1 year are presented as cumulative incidence and 95% confidence interval