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Thomas Bunch

and 10 more

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 Cognitive Decline and Dementia in Patients with Non-Valvular Atrial Fibrillation (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.

Daniel Varela

and 8 more

Background: There exists variability in the administration of inpatient sotalol therapy for symptomatic atrial fibrillation(AF). The impact of this variability on patient in-hospital and 30-day post-hospitalization costs and outcomes is not known. Also, the cost impact of intravenous sotalol, which can accelerate drug loading to therapeutic levels, is unknown. Methods: 133 AF patients admitted for sotalol initiation at an Intermountain Healthcare Hospital from January 2017-December 2018 were included. Patient and dosing characteristics were described descriptively, and the impact of dosing schedule was correlated with daily hospital costs/clinical outcomes during the index hospitalization and for 30 days. The CMS reimbursement for 3-day sotalol initiation is $9,263.51. Projections of cost savings were made considering a 1-day load using intravenous sotalol that costs $2,500.00 to administer. Results: The average age was 70.3±12.3 years, 60.2% were male with comorbidities of: hypertension(83%), diabetes(36%), and coronary artery disease(53%). Mean ejection fraction was 59.9±7.8% and median QTc was 453.7±37.6 ms before sotalol. No ventricular arrhythmias developed, but bradycardia(<60 bpm) was observed in 37.6% of patients. The average length of stay was 3.9±4.6(median: 2.2) days. Post-discharge outcomes and rehospitalization rates stratified by length of stay were similar. The cost per day was estimated at $2,931.55 (1:$2,931.55, 2:$5,863.10, 3:$8,794.65, 4:$11,726.20). Conclusions: Inpatient sotalol dosing is markedly variable and results in the potential of both cost gain and loss to a hospital. In consideration of estimated costs, there is the potential for $871.55 cost savings compared to a 2-day oral load and $3,803.10 compared to a 3-day oral load.