Conclusions
In this prospective randomized vanguard trial of patients with AF at
moderate-high risk of stroke, both the use of dabigatran and warfarin
were associated with similar risks of stroke, cognitive decline, and
dementia at 2 years suggestive that either strategy is acceptable to
mitigate these risks. These clinical outcomes achieved through highly
effective anticoagulation in patients with AF with either ablation
strategy were mechanistically supported by similar levels and changes of
thrombosis, vascular injury, and inflammatory biomarkers measured over
the study duration. These outcomes must be considered in the setting of
a relatively small study population and low incidences of stroke,
dementia, and cognitive decline that can result in a type 2 error of
data interpretation. However, these data combined with those from the
GIRAF study suggest, at this time, that there is no preferential benefit
to dabigatran compared to well-managed warfarin therapy in patients with
AF receiving a new start of anticoagulation to lower risk of cognitive
decline and dementia at 2 years. Next, these data derived from a
Vanguard study did not support the pursuit of a subsequent larger,
adequately powered study.