Shephal K. Doshi, Saibal Kar, Devi G. Nair, Thomas Waggoner, Himanshu Agarwal, Mehran Moussavian, Amir Kashani, Saumil R. Oza, León A. Feldman, Ashish K. Sadhu, David B. DeLurgio, Oluseun Alli, Jens Erik Nielsen-Kudsk, Masanori Yamamoto, Mohamad Alkhouli, A. John Camm, Megan Coylewright, C. Michael Gibson, Christopher B. Granger, Mahmut Edip Gurol, Kenneth C. Huber, Moussa Mansour, Andrea Natale, SJ Pocock, Vivek Y. Reddy, Walid I. Saliba, Federico M Asch, Scott Wehrenberg, Kate Frost, Thomas Christen, Brad S. Sutton, Kenneth M. Steín, Martin B. Leon, Kenneth A. Ellenbogen
BACKGROUND: For patients with atrial fibrillation, the use of oral anticoagulant therapy to prevent stroke is limited by the risk of bleeding. Left atrial appendage closure is considered for patients who are unsuitable candidates for long-term anticoagulation, but its role in patients who are eligible for anticoagulants has not been established. METHODS: In this ongoing, prospective, international, randomized trial involving patients with atrial fibrillation who were suitable candidates for anticoagulation, we randomly assigned patients in a 1:1 ratio to receive either device-based left atrial appendage closure (device group) or non-vitamin K antagonist oral anticoagulant (NOAC) therapy (anticoagulation group). The primary efficacy end point - a composite of death from cardiovascular causes, stroke, or systemic embolism - was tested for noninferiority (noninferiority margin, 4.8 percentage points) after 3 years of follow-up. The primary safety end point, non-procedure-related bleeding, was tested for superiority. RESULTS: -VASc score was 3.5±1.3. At 3 years, a primary efficacy end-point event had occurred in 81 patients (Kaplan-Meier estimate, 5.7%) in the device group and in 65 patients (Kaplan-Meier estimate, 4.8%) in the anticoagulation group (difference, 0.9 percentage points; 95% confidence interval [CI], -0.8 to 2.6; P<0.001 for noninferiority). Non-procedure-related bleeding occurred in 154 patients (Kaplan-Meier estimate, 10.9%) in the device group and in 260 patients (Kaplan-Meier estimate, 19.0%) in the anticoagulation group (hazard ratio, 0.55; 95% CI, 0.45 to 0.67; P<0.001 for superiority). CONCLUSIONS: Among patients with atrial fibrillation who were candidates for anticoagulation, device-based left atrial appendage closure was noninferior to NOAC therapy with respect to a composite of death from cardiovascular causes, stroke, or systemic embolism and was superior to NOAC therapy for non-procedure-related bleeding at 3 years. (Funded by Boston Scientific; CHAMPION-AF ClinicalTrials.gov number, NCT04394546.).