University Report: Stroke Prevention in Atrial Fibrillation Evaluation

This report critically analyzes two journal articles focused on stroke prevention in patients with atrial fibrillation (AF). The first article, by Holmes et al. (2015), investigates left atrial appendage closure (LAAC) as an alternative to warfarin, comparing outcomes in patients with non-valvular atrial fibrillation (NVAF). The second article, by Kirchhof et al. (2013), presents the rationale and design of the Early Treatment of Atrial Fibrillation for Stroke Prevention Trial (EAST), focusing on early rhythm control strategies. The report examines the population of interest, inclusion and exclusion criteria, sampling methods, sample sizes, allocation methods, treatment and control groups, blinding types, and overall study outcomes. The studies are compared, highlighting key findings such as the reduced risk of stroke and bleeding with LAAC compared to warfarin, and the importance of early intervention in managing AF. The report concludes by summarizing the key findings and implications of both studies for clinical practice.

Running head: STROKE PREVENTION IN ATRIAL FIBRILLATION
Stroke prevention in atrial fibrillation
Name of the Student
Name of the University
Author Note

1STROKE PREVENTION IN ATRIAL FIBRILLATION
Article Holmes, D. R., Doshi, S. K.,
Kar, S., Price, M. J., Sanchez,
J. M., Sievert, H., ... & Reddy,
V. Y. (2015). Left atrial
appendage closure as an
alternative to warfarin for
stroke prevention in atrial
fibrillation: a patient-level
meta-analysis. Journal of the
American College of
Cardiology, 65(24), 2614-
2623.
doi:10.1016/j.jacc.2015.04.02
5
Kirchhof, P., Breithardt, G.,
Camm, A. J., Crijns, H. J.,
Kuck, K.-H., Vardas, P., &
Wegscheider, K. (2013).
Improving outcomes in
patients with atrial
fibrillation: Rationale and
design of the Early treatment
of Atrial fibrillation for
Stroke prevention Trial.
American Heart Journal,
166(3), 442–448.
doi:10.1016/j.ahj.2013.05.015
Population of Interest Patients with riskier non-
valvular atrial fibrillation or
the NVAF.
Patients from selected eleven
European countries with latest
beginning AF at risk for
stroke.
Inclusion & exclusion criteria The inclusion criteria included
patients with increased risk
non-valvular atrial fibrillation,
enrollment of 2406 patients,
The inclusion criteria
included recent-onset AF (≤1
year before enrollment), At
least 1 ECG within recent 12

2STROKE PREVENTION IN ATRIAL FIBRILLATION
Patient-Years or PY of 5931.
The exclusion criteria included
patients who are not at high
risk NVAF along with the
contraindicated patients.
m that documents AF,
whereas the AF episode must
last longer than 30 seconds,
age ≥ 18 y and signed
content. The excluded criteria
included any ailment that
restricts life expectancy to
less than a year, breastfeeding
women, drug abuse and
earlier involvement in the
EAST trial.
Sampling Method The sampling method included
a quantitative analysis
approach in form of a survey
and the data has been analyzed
using outmoded frequentist
statistical methods (Holmes et
al., 2015).
The sampling method
included a quantitative
analysis approach in form of a
questionnaire and the data has
been analyzed using primary
analysis methods (Kirchhof et
al., 2013).

3STROKE PREVENTION IN ATRIAL FIBRILLATION
Sample size The sample size for this
chosen article included an
enrollment of 2406 patients
with Patient-Years or PY of
5931.
The sample size for this
chosen article included an
enrollment of 3000 patients
from eleven European
countries.
Allocation Method The allocation method
included follow up from the
PROTECT AF (Watchman
Left Atrial Appendage System
for Embolic Protection in
Patients with Atrial
Fibrillation) and PREVAIL
(Prospective Randomized
Evaluation of the Watchman
LAA Closure Device In
Patients With Atrial
Fibrillation Versus Long Term
Warfarin Therapy) trials along
with their respective registries
that are Continued Access to
PROTECT AF (CAP) registry
and Continued Access to
PREVAIL (CAP2) registry
The allocation method
included follow up by yearly
basis along with a
questionnaire at a biannual
interval. The follow up
process is event driven and is
continued until the
termination of the trial.

4STROKE PREVENTION IN ATRIAL FIBRILLATION
(Holmes et al., 2015).
Treatment and Control Groups The two major classifications
included the Left Atrial
Appendage Closure (LAAC)
and Systemic Therapy
(warfarin) both in contrast to
each other.
The two major classifications
included the Early Rhythm
Control therapy and the Usual
Care (Kirchhof et al., 2013).
Type of blinding Single masking or single
blinding type has been used
(Petersen et al., 2017).
Unblinded or open label has
been used (Nauck et al.,
2016).
Overall study outcomes In NVAF with high stroke
risk, patients who have been
treated with Watchman Device
with LAAC have lesser
probability of stroke, death or
bleeding as compared to that
of patients who have been
treated with chronic warfarin
(Holmes et al., 2015).
The present practice of
initially selecting a rate
control strategy in managing
the Atrial Fibrillation has
developed consistent
disappointment in multiple
trials with rhythm control
(Kirchhof et al., 2013).

5STROKE PREVENTION IN ATRIAL FIBRILLATION
References
Holmes, D. R., Doshi, S. K., Kar, S., Price, M. J., Sanchez, J. M., Sievert, H., ... & Reddy, V. Y.
(2015). Left atrial appendage closure as an alternative to warfarin for stroke prevention in
atrial fibrillation: a patient-level meta-analysis. Journal of the American College of
Cardiology, 65(24), 2614-2623.
Kirchhof, P., Breithardt, G., Camm, A. J., Crijns, H. J., Kuck, K.-H., Vardas, P., & Wegscheider,
K. (2013). Improving outcomes in patients with atrial fibrillation: Rationale and design of
the Early treatment of Atrial fibrillation for Stroke prevention Trial. American Heart
Journal, 166(3), 442–448. doi:10.1016/j.ahj.2013.05.015
Nauck, M. A., Petrie, J. R., Sesti, G., Mannucci, E., Courrèges, J. P., Lindegaard, M. L., ... &
Atkin, S. L. (2016). A phase 2, randomized, dose-finding study of the novel once-weekly
human GLP-1 analog, semaglutide, compared with placebo and open-label liraglutide in
patients with type 2 diabetes. Diabetes care, 39(2), 231-241.
Petersen, A. S., Barloese, M. C., Lund, N. L., & Jensen, R. H. (2017). Oxygen therapy for cluster
headache. A mask comparison trial. A single-blinded, placebo-controlled, crossover
study. Cephalalgia, 37(3), 214-224.