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.

摘要: Objectives This study sought to assess quality of life parameters in a subset patients enrolled the PROTECT AF (Percutaneous Closure Left Atrial Appendage Versus Warfarin Therapy for Prevention Stroke Patients With Fibrillation) trial. Background The trial demonstrated that with nonvalvular atrial fibrillation (AF) and CHADS2 (congestive heart failure, hypertension, age, diabetes mellitus, prior stroke, transient ischemic attack, or thromboembolism) score ≥1, left appendage closure device is noninferior long-term warfarin stroke prevention. Given this equivalency, (QOL) indicators are an important metric evaluating these 2 different strategies. Methods QOL using Short-Form 12 Health Survey, version 2, measurement tool was obtained at baseline months 547 (361 186 patients). analysis cohort consisted whom either paired data were available after follow-up who died. Results device, total physical improved 34.9% unchanged 29.9% versus 24.7% 31.7% (p = 0.01). Mental health improvement occurred 33.0% group 22.6% 0.06). There significant randomized score, function, role limitation compared control. differences change among naive not–warfarin subgroups control, but larger gains seen subgroup 12-month 1.3 ± 8.8 −3.6 6.7 0.0004) warfarin. Conclusions risk treated have favorable changes (WATCHMAN System Embolic Protection Fibrillation [WATCHMAN PROTECT]; NCT00129545 )