Table 2.
Outcome | Analysis | Exposure group | No. of events | Follow-up, y* | IR, per 100 person-y | HR (95% CI) | |
---|---|---|---|---|---|---|---|
All-cause mortality | ITT | Warfarin | 832 | 1.34 ± 1.10; 1.01 | 33.0 | 1.01 (0.92-1.11) | |
No warfarin | 4595 | 1.35 ± 1.14 | 1.01 | 32.5 | |||
AT60a | Warfarin | 375 | 0.60 ± 0.63 | 0.36 | 31.7 | 0.84 (0.73-0.97) | |
No warfarin | 4005 | 1.19 ± 1.11 | 0.84 | 32.1 | |||
Cardiovascular mortality | ITT | Warfarin | 349 | 1.34 ± 1.10 | 1.01 | 13.8 | 1.00 (0.86-1.17) |
No warfarin | 1940 | 1.35 ± 1.14 | 1.01 | 13.7 | |||
AT60a | Warfarin | 184 | 0.60 ± 0.65 | 0.36 | 15.6 | 0.87 (0.70-1.07) | |
No warfarin | 2071 | 1.22 ± 1.13 | 0.85 | 16.4 | |||
Ischemic stroke | ITT | Warfarin | 63 | 1.42 ± 1.19 | 1.07 | 2.3 | 0.68 (0.47-0.99) |
No warfarin | 503 | 1.40 ± 1.21 | 1.01 | 3.4 | |||
AT60a | Warfarin | 32 | 0.61 ± 0.67 | 0.36 | 2.7 | 0.73 (0.44-1.20) | |
No warfarin | 497 | 1.30 ± 1.20 | 0.89 | 3.7 | |||
Hemorrhagic stroke | ITT | Warfarin | 29 | 1.46 ± 1.20 | 1.09 | 1.0 | 0.82 (0.37-1.81) |
No warfarin | 192 | 1.44 ± 1.23 | 1.05 | 1.3 | |||
AT60a | Warfarin | 26 | 0.61 ± 0.68 | 0.35 | 2.1 | 1.92 (0.82-4.48) | |
No warfarin | 172 | 1.34 ± 1.23 | 0.94 | 1.2 | |||
Any stroke or stroke death | ITT | Warfarin | 116 | 1.40 ± 1.17 | 1.06 | 4.4 | 0.83 (0.61-1.12) |
No warfarin | 765 | 1.38 ± 1.19 | 1.00 | 5.3 | |||
AT60a | Warfarin | 61 | 0.65 ± 0.69 | 0.40 | 5.0 | 0.87 (0.57-1.32) | |
No warfarin | 650 | 1.19 ± 1.12 | 0.80 | 5.2 | |||
Gastrointestinal bleeding | ITT | Warfarin | 153 | 1.36 ± 1.15 | 0.97 | 5.9 | 1.00 (0.69-1.44) |
No warfarin | 833 | 1.36 ± 1.19 | 0.98 | 5.9 | |||
AT60a | Warfarin | 108 | 0.60 ± 0.65 | 0.34 | 9.0 | 1.36 (0.89-2.07) | |
No warfarin | 782 | 1.25 ± 1.18 | 0.86 | 6.0 | |||
Composite outcomeb | ITT | Warfarin | 890 | 1.23 ± 1.06 | 0.91 | 38.8 | 1.01 (0.93-1.11) |
No warfarin | 4961 | 1.25 ± 1.10 | 0.91 | 38.1 | |||
ATa | Warfarin | 427 | 0.61 ± 0.65 | 0.37 | 37.7 | 0.89 (0.78-1.02) | |
No warfarin | 4219 | 1.08 ± 1.03 | 0.75 | 37.1 |
AT60 – as-treated analysis where patients were censored 60 days after their drug supply ran out; CI – confidence interval, HR, hazard ratio; ITT – intention to treat,
Values given as mean ± standard deviation; median.
Stratified Cox by year when atrial fibrillation was diagnosed.
Composite outcome includes any stroke or stroke death, gastrointestinal bleeding, and all-cause mortality.