BHS107A Research and Evidence-Based Practice

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.2015.04.025

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, Patient-Years or PY of 5931. The exclusion criteria included patients who are not at high risk NVAF along with the contraindicated patients.

The inclusion criteria included recent-onset AF (≤1 year before enrollment), At least 1 ECG within recent 12 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).

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 (Holmes et al., 2015).

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.

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).