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Quality of Life Assessment in the Randomized PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) Trial of Patients at Risk for Stroke With Nonvalvular Atrial Fibrillation
Study Questions:
How does the use of a left atrial appendage (LAA) occlusion device instead of warfarin for stroke prevention in patients with atrial fibrillation (AF) affect quality of life (QOL)?
Methods:
The subjects of this study were 547 patients (mean age 72 years) with AF and ≥1 risk factor for stroke (mean CHADS2 score 2.2). The patients were randomly assigned to receive an LAA occlusion device (n = 361) or dose-adjusted warfarin (n = 186). QOL was assessed at baseline and 12 months of follow-up with the Short Form-12 survey.
Results:
The total physical score improved in a significantly larger proportion of patients in the device group (34.9%) than in the warfarin group (24.7%). Compared to the warfarin group, the patients in the device group had a significant improvement in physical function and physical limitation scores. The mental health score improved in 33% of patients in the device group and 22.6% of patients in the warfarin group, but this was not a significant difference. Overall, QOL decreased in the warfarin group.
Conclusions:
The authors concluded that QOL improves to a modest degree in patients who receive an LAA occlusion device for stroke prevention, and decreases in patients who are anticoagulated with warfarin.
Perspective:
Given the need for ongoing monitoring of the international normalized ratio, the fear of bleeding complications, and the inconvenience of dietary restrictions, it is not surprising that the use of warfarin in this study was associated with a decrease in QOL. However, the new anticoagulants (i.e., dabigatran, rivaroxaban, apixaban) do not share many of the disadvantages of warfarin, and the effects of these agents on QOL remain to be determined.
Keywords: Stroke, Follow-Up Studies, Morpholines, Oxidation-Reduction, Warfarin, Risk Factors, Pyrazoles, International Normalized Ratio, Blood Coagulation, beta-Alanine, Atrial Appendage, Benzimidazoles, Quality of Life, Lactones, Pyridones, Mental Health, Mitogen-Activated Protein Kinases
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