03417nam a2200373   4500001000800000005001700008007000300025008004100028040000800069041000800077100003600085245007700121300002500198520223900223650002902462650002702491650002102518650002502539650002202564650002702586700002502613700002602638700002902664700003002693700003102723700002602754700002402780700002602804700002602830700002902856773011002885942003102995999001703026ESSALUD20260819163736.0ta      t        pe ||||| |||| 00| 0 spa d  aBMG  aeng  aDoshi, Shephal K.eAutor954162  aLeft atrial appendage closure or anticoagulation for atrial fibrillation  apáginas: 2083-2094  aBackground: 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: 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.  aANTICOAGULACIÓN953834  aTROMBOEMBOLISMO932218  aARRITMIAS953863  aCARDIOLOGÍA911301  aMARCAPASOS953864  aDESFIBRILADORES953865  aKar, Saibal  954163  aNair, Devi G. 953867  aWaggoner, Thomas 954164  aAgarwal, Himanshu 954165  aMoussavian, Mehran 954166  aKashani, Amir 954167  aOza, Saumil 954168  aFeldman, Leon 954169  aSadhu, Ashish 954170  aDeLurgio, David  9541710 022717922648dMassachusetts NEJM GroupoNEJM011tThe New England Journal of Medicine wESSALUDx0028-4793  cARTICULOSe2026-08-19zsqb  c22833d22833