Fixed dose oral ximelagatran (Xim) v adjusted dose warfarin (War) in non-valvular atrial fibrillation requiring long term anticoagulation therapy at mean 20 months*

OutcomesEvent rate per patient yearDifference (95% CI)
*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 embolism1.6%1.2%0.45% (–0.13 to 1.0)†
Myocardial infarction1.0%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 combined37%47%–10% (–14 to –6.0)§||