Left Atrial Appendage Closure or Anticoagulation for Atrial Fibrillation.
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Doshi Shephal K, Kar Saibal, Nair Devi G, Waggoner Thomas, Agarwal Himanshu, Moussavian Mehran, Kashani Amir, Oza Saumil, Feldman Leon, Sadhu Ashish, DeLurgio David, Alli Oluseun, Nielsen-Kudsk Jens Erik, Yamamoto Masanori, Alkhouli Mohamad, Camm A John, Coylewright Megan, Gibson C Michael, Granger Christopher B, Gurol Mahmut Edip, Huber Kenneth C, Mansour Moussa, Natale Andrea, Pocock Stuart J, Reddy Vivek Y, Saliba Walid I, Asch Federico M, Wehrenberg Scott, Frost Kate, Christen Thomas, Sutton Brad S, Stein Kenneth M, Leon Martin B, Ellenbogen Kenneth A, CHAMPION-AF Investigators
Аннотация
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: Of the 3000 patients who underwent randomization, 1499 were assigned to the device group and 1501 to the anticoagulation group. The mean (±SD) age of the patients was 71.7±7.5 years, 31.9% of the patients were women, and the mean CHA2DS2-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.).