Conflict of Interest/Disclosure
TJB: Research grants: Altathera, Boehinger Ingelheim, Boston Scientific,
Heartline Study Steering Committee for Janssen Scientific
Affairs/Johnson & Johnson.
HM: None
MJC: Heartline Study Steering Committee for Janssen Scientific
Affairs/Johnson & Johnson.
SCW: None
VJ: None
SMS: None
JC: None
KUK: None
JBM: None
BAS: National Heart, Lung, And Blood Institute of the National
Institutes of Health (#K23HL143156), and reports research support from
Abbott, Boston Scientific, and Janssen; and consulting to Janssen,
AltaThera, Merit Medical, and Bayer; and speaking for NACCME (funded by
Sanofi).
JLA: None
Background: Atrial fibrillation (AF) is associated with a risk for
cognitive impairment and dementia, which is more pronounced in patients
with a history of clinical stroke. Anticoagulation use and efficacy
impact long-term risk of dementia in AF patients in observational
trials.
Methods: The C ognitive Decline and Dementia in Patients
with Non-Valvular A trial F ibrillation (CAF) Trial was a
randomized, prospective, open-label vanguard clinical study with blinded
endpoint assessment involving patients with moderate- to high-risk
(CHADS2 or CHA2DS2-Vasc scores of ≥2) non-valvular AF assigned to
dabigatran etexilate or warfarin. The primary endpoint was incident
dementia or moderate cognitive decline at 24 months.
Results: A total of 101 patients were enrolled, of which 50
received dabigatran and 51 warfarin anticoagulation. The mean age was
73.7±6.0 years and 54(53.5%) were male. Prior stroke and stroke risk
factors were similar between groups. Average INR over the study was
2.41±0.68 in the warfarin group. No patient experienced a stroke or
developed dementia. Mini-Mental Status Evaluation, Hachinski Ischemic
scale, cognitive subscale of the Alzheimer’s Disease Assessment Scale,
Disability Assessment for Dementia, Quality of Life Improvement as
assessed by Minnesota Living with Heart Failure Scale and the Anti-Clot
Treatment Scale Quality of Life Survey scores did not vary at baseline
or change over 2 years. Biomarker analysis indicated a similar efficacy
of anticoagulation strategies
Conclusion: Use of dabigatran and well-managed warfarin therapy
were associated with similar risks of stroke, cognitive decline, and
dementia at 2 years, suggestive that either strategy is acceptable to
mitigate these risks. The results of this Vanguard study did not support
the pursuit of a larger formally powered study.
Keywords: atrial fibrillation; stroke; cognition; dementia;
anticoagulants