Left Atrial Appendage Closure or Anticoagulation for Atrial Fibrillation

作者：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 · 发表于：New England Journal of Medicine · 年份：2026 · DOI：10.1056/nejmoa2517213 · 被引用次数：32 · 研究领域：Atrial Fibrillation Management and Outcomes、Aortic Thrombus and Embolism、Pericarditis and Cardiac Tamponade

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...