000 03414nam a2200373 4500
001 ESSALUD
005 20260819163736.0
007 ta
008 t pe ||||| |||| 00| 0 spa d
040 _aBMG
041 _aeng
100 _aDoshi, Shephal K.
_eAutor
_954162
245 _aLeft atrial appendage closure or anticoagulation for atrial fibrillation
300 _apáginas: 2083-2094
520 _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.
650 _aANTICOAGULACIÓN
_953834
650 _aTROMBOEMBOLISMO
_932218
650 _aARRITMIAS
_953863
650 _aCARDIOLOGÍA
_911301
650 _aMARCAPASOS
_953864
650 _aDESFIBRILADORES
_953865
700 _aKar, Saibal
_954163
700 _aNair, Devi G.
_953867
700 _aWaggoner, Thomas
_954164
700 _aAgarwal, Himanshu
_954165
700 _aMoussavian, Mehran
_954166
700 _aKashani, Amir
_954167
700 _aOza, Saumil
_954168
700 _aFeldman, Leon
_954169
700 _aSadhu, Ashish
_954170
700 _aDeLurgio, David
_954171
773 0 _022717
_922648
_dMassachusetts NEJM Group
_oNEJM011
_tThe New England Journal of Medicine
_wESSALUD
_x0028-4793
942 _cARTICULOS
_e2026-08-19
_zsqb
999 _c22833
_d22833