TY - JOUR
T1 - 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
AU - Alli, Oluseun
AU - Doshi, Shepal
AU - Kar, Saibal
AU - Reddy, Vivek
AU - Sievert, Horst
AU - Mullin, Chris
AU - Swarup, Vijay
AU - Whisenant, Brian
AU - Holmes, David
N1 - Funding Information:
Drs. Reddy and Holmes have received research grant support from Atritech, Inc . In addition, the WATCHMAN LAA closure technology has been licensed to Atritech, and both Mayo Clinic and Dr. Holmes have contractual rights to receive future royalties from this license. Drs. Doshi and Kar have received research grant support from and are consultants to Atritech, Inc . Dr. Kar is also a consultant to Boston Scientific, Abbott Vascular, and Coherex; has received research grants from Boston Scientific , Abbott Vascular , St. Jude Medical ; and has equity in Coherex. Dr. Reddy is a consultant to Boston Scientific. Dr. Sievert reports financial relationships with Abbott, Access Closure, AGA, Angiomed, Aptus, Arstasis, Atritech, Atrium, Avinger, Bard, Boston Scientific, Bridgepoint, Cardiac Dimensions, CardioKinetix, CardioMEMS, Coherex, Contego, CSI, CVRx, EndoCross, EndoTex, Epitek, ev3, FlowCardia, Gore, Guidant, Guided Delivery Systems, InSeal Medical, Lumen Biomedical, HLT, Kensey Nash, Kyoto Medical, Lifetech, Lutonix, Maya Medical, Medinol, Medtronic, NDC, NMT, OAS, Occlutech, Osprey, Ovalis, Pathway, PendraCare, Percardia, pfm Medical, Recor, ResMed, Rox Medical, Sadra, Sorin, Spectranetics, SquareOne, Trireme, Trivascular, Velocimed, Veryan, and Vessix. Dr. Mullin is a paid consultant for NAMSA. Dr. Swarup has research relationships with Biosense Webster, St. Jude Medical, Boston Scientific, Medtronic, and Biotronik. Dr. Whisenant is a consultant to and has equity in Coherex. Dr. Alli has reported he has no relationships relevant to the contents of this paper to disclose.
PY - 2013/4/30
Y1 - 2013/4/30
N2 - Objectives: This study sought to assess quality of life parameters in a subset of patients enrolled in the PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial. Background: The PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial demonstrated that in patients with nonvalvular atrial fibrillation (AF) and CHADS2 (congestive heart failure, hypertension, age, diabetes mellitus, and prior stroke, transient ischemic attack, or thromboembolism) score ≥1, a left atrial appendage closure device is noninferior to long-term warfarin for stroke prevention. Given this equivalency, quality of life (QOL) indicators are an important metric for evaluating these 2 different strategies. Methods: QOL using the Short-Form 12 Health Survey, version 2, measurement tool was obtained at baseline and 12 months in a subset of 547 patients in the PROTECT AF trial (361 device and 186 warfarin patients). The analysis cohort consisted of patients for whom either paired quality of life data were available after 12 months of follow-up or for patients who died. Results: With the device, the total physical score improved in 34.9% and was unchanged in 29.9% versus warfarin in whom 24.7% were improved and 31.7% were unchanged (p = 0.01). Mental health improvement occurred in 33.0% of the device group versus 22.6% in the warfarin group (p = 0.06). There was a significant improvement in QOL in patients randomized to device for total physical score, physical function, and in physical role limitation compared to control. There were significant differences in the change in total physical score among warfarin naive and not-warfarin naive subgroups in the device group compared to control, but larger gains were seen with the warfarin naive subgroup with a 12-month change of 1.3 ± 8.8 versus -3.6 ± 6.7 (p = 0.0004) device compared to warfarin. Conclusions: Patients with nonvalvular AF at risk for stroke treated with left atrial appendage closure have favorable QOL changes at 12 months versus patients treated with warfarin. (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation [WATCHMAN PROTECT]; NCT00129545)
AB - Objectives: This study sought to assess quality of life parameters in a subset of patients enrolled in the PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial. Background: The PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial demonstrated that in patients with nonvalvular atrial fibrillation (AF) and CHADS2 (congestive heart failure, hypertension, age, diabetes mellitus, and prior stroke, transient ischemic attack, or thromboembolism) score ≥1, a left atrial appendage closure device is noninferior to long-term warfarin for stroke prevention. Given this equivalency, quality of life (QOL) indicators are an important metric for evaluating these 2 different strategies. Methods: QOL using the Short-Form 12 Health Survey, version 2, measurement tool was obtained at baseline and 12 months in a subset of 547 patients in the PROTECT AF trial (361 device and 186 warfarin patients). The analysis cohort consisted of patients for whom either paired quality of life data were available after 12 months of follow-up or for patients who died. Results: With the device, the total physical score improved in 34.9% and was unchanged in 29.9% versus warfarin in whom 24.7% were improved and 31.7% were unchanged (p = 0.01). Mental health improvement occurred in 33.0% of the device group versus 22.6% in the warfarin group (p = 0.06). There was a significant improvement in QOL in patients randomized to device for total physical score, physical function, and in physical role limitation compared to control. There were significant differences in the change in total physical score among warfarin naive and not-warfarin naive subgroups in the device group compared to control, but larger gains were seen with the warfarin naive subgroup with a 12-month change of 1.3 ± 8.8 versus -3.6 ± 6.7 (p = 0.0004) device compared to warfarin. Conclusions: Patients with nonvalvular AF at risk for stroke treated with left atrial appendage closure have favorable QOL changes at 12 months versus patients treated with warfarin. (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation [WATCHMAN PROTECT]; NCT00129545)
KW - atrial fibrillation
KW - health-related quality of life
KW - left atrial appendage occlusion
KW - stroke prevention
KW - warfarin
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U2 - 10.1016/j.jacc.2013.01.061
DO - 10.1016/j.jacc.2013.01.061
M3 - Article
C2 - 23500276
AN - SCOPUS:84876580352
SN - 0735-1097
VL - 61
SP - 1790
EP - 1798
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 17
ER -