Results
The baseline demographics of the study population are shown in Table 1.
Among the 101 patients randomized 50 were randomized to dabigatran
(49.5%) and 51 to warfarin (50.5%). The groups were balanced with the
exception of coronary artery disease and treatment of coronary artery
disease that was more prevalent in the warfarin treated group.
Of the patients enrolled in the study, 64% of those randomized to
dabigatran and 61% of those randomized to warfarin completed the study.
Supplemental Table 1 shows the reasons provided for discontinuing drug
therapy.
Table 2 shows the baseline demographics of the study population that
completed the study. In the dabigatran group, more patients had worse
subtypes of AF (persistent and longstanding persistent) compared to the
group treated with warfarin and a history of cancer was more common in
the warfarin group.
The two year results data and secondary endpoints of Stroke or Transient
ischemic attack (TIA), intracranial bleed, and changes from baseline
scores on the mini-mental status evaluation and the Hachinski Ischemic
Scale are shown in Table 3. No differences were observed in is rates of
dementia or cognitive decline as measured by serial assessment. The
incidence of new stroke and TIA were similar between groups and there
were no significant changes detected in the MMSE or HIS surveys. During
this period of time, 4 patients underwent a cardioversion, 1 received a
pacemaker, none underwent an ablation, and 6 were start on
antiarrhythmic drug therapy.
The survey scores of multiple tests for dementia, stroke, cognitive
decline, and general function are shown in Table 4 and shown for 4
surveys in Figure 1. The scores were similar at baseline and 24 months
without significant differences observed in the dabigatran versus
warfarin groups amongst all surveys.
Finally, the results of the biomarker data are listed in Table 5 which
were similar at baseline and 24 months that suggest similar efficacy of
anticoagulation and consistent impact of it with both anticoagulation
strategies. In addition, the data showed similar levels of Neprilysin
and the single-nucleotide polymorphism rs6656401 and Complement
Receptor-1gene that may have adversely impacted cerebral amyloid
angiopathy risk. Additional APOE profiling was similar amongst groups
and did not associate with abnormal cognitive survey scores at 24
months.
In the subgroup of patients that underwent MRI testing, there were no
new strokes (clinical or subclinical) identified during the study
follow-up or quantifiable change in volume (supplemental Table 2).