Table 2. Median days of follow-up, number of events, crude incidence rate per 100 person years and hazard ratio of effectiveness and safety outcomes in new users of dabigatran, rivaroxaban or apixaban compared to warfarin for non-valvular atrial fibrillation.
| Outcome | Oral anticoagulant | Median days of follow-up (min-max) |
No. of events | Incidence rate (per 100 person years) |
Hazard ratio (95% confidence interval)§ | ||
|---|---|---|---|---|---|---|---|
| Crude | Partially adjusted | Fully adjusted | |||||
| Ischemic stroke, TIA or systemic embolism | Warfarin | 248 (1–365) | 124 | 2.99 | 1 | 1 | 1 |
| Dabigatran | 211 (1–365) | 88 | 2.48 | 0.80 | 0.92 (0.69–1.21) | 0.96 (0.71–1.28) | |
| Rivaroxaban | 164 (1–365) | 140 | 3.48 | 1.08 | 1.09 (0.85–1.40) | 1.12 (0.87–1.45) | |
| Apixaban | 150 (1–365) | 180 | 3.56 | 1.06 | 1.00 (0.79–1.28) | 0.97 (0.75–1.26) | |
| Ischemic stroke or systemic embolism | Warfarin | 250 (1–365) | 91 | 2.19 | 1 | 1 | 1 |
| Dabigatran | 212 (1–365) | 62 | 1.74 | 0.77 | 0.86 (0.62–1.19) | 0.90 (0.64–1.27) | |
| Rivaroxaban | 164 (1–365) | 111 | 2.75 | 1.16 | 1.14 (0.86–1.51) | 1.23 (0.91–1.65) | |
| Apixaban | 150 (1–365) | 144 | 2.84 | 1.14 | 1.02 (0.77–1.35) | 1.00 (0.74–1.35) | |
| Ischemic stroke | Warfarin | 250 (1–365) | 84 | 2.02 | 1 | 1 | 1 |
| Dabigatran | 212 (1–365) | 60 | 1.68 | 0.80 | 0.89 (0.63–1.25) | 0.93 (0.65–1.32) | |
| Rivaroxaban | 164 (1–365) | 104 | 2.58 | 1.17 | 1.14 (0.85–1.53) | 1.22 (0.90–1.66) | |
| Apixaban | 150 (1–365) | 141 | 2.78 | 1.20 | 1.07 (0.81–1.43) | 1.05 (0.77–1.42) | |
| Transient ischemic attack | Warfarin | 251 (1–365) | 35 | 0.84 | 1 | 1 | 1 |
| Dabigatran | 213 (1–365) | 28 | 0.78 | 0.92 | 1.12 (0.67–1.86) | 1.11 (0.65–1.90) | |
| Rivaroxaban | 166 (1–365) | 33 | 0.81 | 0.93 | 1.00 (0.61–1.62) | 0.89 (0.54–1.48) | |
| Apixaban | 152 (1–365) | 41 | 0.80 | 0.90 | 0.96 (0.59–1.55) | 0.87 (0.52–1.45) | |
| Major or clinically relevant non-major bleeding | Warfarin | 237 (1–365) | 490 | 12.19 | 1 | 1 | 1 |
| Dabigatran | 205 (1–365) | 245 | 6.99 | 0.57 | 0.71 (0.60–0.83) | 0.73 (0.62–0.86) | |
| Rivaroxaban | 155 (1–365) | 412 | 10.45 | 0.84 | 0.95 (0.83–1.08) | 0.97 (0.84–1.12) | |
| Apixaban | 148 (1–365) | 446 | 8.94 | 0.70 | 0.73 (0.63–0.83) | 0.71 (0.62–0.82) | |
| Intracranial bleeding | Warfarin | 252 (1–365) | 48 | 1.15 | 1 | 1 | 1 |
| Dabigatran | 214 (1–365) | 11 | 0.31 | 0.27 | 0.31 (0.16–0.60) | 0.28 (0.14–0.56) | |
| Rivaroxaban | 167 (1–365) | 20 | 0.49 | 0.42 | 0.45 (0.27–0.77) | 0.40 (0.23–0.69) | |
| Apixaban | 152 (1–365) | 37 | 0.72 | 0.61 | 0.66 (0.41–1.05) | 0.56 (0.34–0.92) | |
| Gastrointestinal bleeding | Warfarin | 248 (1–365) | 124 | 2.98 | 1 | 1 | 1 |
| Dabigatran | 212 (1–365) | 84 | 2.36 | 0.78 | 1.04 (0.79–1.39) | 1.10 (0.82–1.48) | |
| Rivaroxaban | 164 (1–365) | 121 | 3.00 | 0.97 | 1.15 (0.89–1.49) | 1.21 (0.92–1.59) | |
| Apixaban | 151 (1–365) | 112 | 2.20 | 0.70 | 0.71 (0.55–0.94) | 0.70 (0.52–0.93) | |
| Other bleeding | Warfarin | 240 (1–365) | 357 | 8.80 | 1 | 1 | 1 |
| Dabigatran | 207 (1–365) | 164 | 4.65 | 0.52 | 0.65 (0.53–0.78) | 0.67 (0.55–0.81) | |
| Rivaroxaban | 157 (1–365) | 311 | 7.84 | 0.87 | 0.98 (0.84–1.15) | 1.02 (0.87–1.20) | |
| Apixaban | 149 (1–365) | 317 | 6.32 | 0.69 | 0.72 (0.61–0.84) | 0.70 (0.59–0.83) | |
CHA2DS2-VASc: congestive heart failure, hypertension, age ≥75 [doubled], previous stroke/TIA/systemic embolism [doubled], vascular disease, age 65–74, female sex. Modified HAS-BLED: hypertension, abnormal liver/kidney function, previous stroke/TIA/systemic embolism, bleeding history, age >65, alcohol abuse or concomitant use of non-steroidal anti-inflammatory drugs or platelet inhibitor.
§: Hazard ratios for the risk of an outcome for dabigatran, rivaroxaban or apixaban compared to warfarin in Cox proportional hazard models with no adjustment (crude); adjusted for year and risk factors of CHA2DS2-VASc and modified HAS-BLED (partially adjusted); and adjusted for all predefined covariates (fully adjusted).