Table 2.
Bleeding outcomes in ARISTOTLE | |||||
---|---|---|---|---|---|
Type of | Apixaban event | Warfarin event | HR (apixaban/) | ||
bleeding | rate (% per year) | rate (% per year) | (warfarin) | 95% CI | P value |
ISTH major | 2.13 | 3.09 | 0.69 | (0.60–0.80) | <0.0001 |
ISTH major/CRNM | 4.07 | 6.01 | 0.68 | (0.61–0.75) | <0.0001 |
TIMI major | 0.96 | 1.69 | 0.57 | (0.46–0.70) | <0.0001 |
GUSTO severe | 0.52 | 1.13 | 0.46 | (0.35–0.60) | <0.0001 |
Intracranial | 0.33 | 0.80 | 0.42 | (0.30–0.58) | <0.0001 |
Fatal | 0.06 | 0.24 | 0.27 | (0.13–0.53) | 0.0002 |
Note that as the severity of the bleeding outcome increases, the hazard ratio of apixaban to warfarin decreases, indicating a favorable trend for safety.29