Fixed dose oral ximelagatran (Xim) v adjusted dose warfarin (War) in non-valvular atrial fibrillation requiring long term anticoagulation therapy at mean 20 months*
| Outcomes | Event rate per patient year | Difference (95% CI) | |
|---|---|---|---|
| Xim | War | ||
| *CI defined in glossary. †Intention to treat analysis; criterion for non-inferiority was met because the upper limit of the 95% CI was <2%/year. ‡CI provided by author. §On treatment analysis that discounted events after treatment cessation. ||Significant difference favours xim. | |||
| Any stroke (ischaemic or haemorrhagic) or systemic embolism | 1.6% | 1.2% | 0.45% (–0.13 to 1.0)† |
| Myocardial infarction | 1.0% | 1.4% | −0.4% {−0.9 to 0.2}‡§ |
| Major bleeding (excluding extracerebral) | 2.4% | 3.1% | −0.66% (−1.6 to 0.23)§ |
| Major and minor bleeding combined | 37% | 47% | –10% (–14 to –6.0)§|| |