| 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 |
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| 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 |
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| 650 |
_aTROMBOEMBOLISMO _932218 |
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| 650 |
_aARRITMIAS _953863 |
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| 650 |
_aCARDIOLOGÍA _911301 |
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| 650 |
_aMARCAPASOS _953864 |
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| 650 |
_aDESFIBRILADORES _953865 |
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| 700 |
_aKar, Saibal _954163 |
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| 700 |
_aNair, Devi G. _953867 |
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| 700 |
_aWaggoner, Thomas _954164 |
||
| 700 |
_aAgarwal, Himanshu _954165 |
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| 700 |
_aMoussavian, Mehran _954166 |
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| 700 |
_aKashani, Amir _954167 |
||
| 700 |
_aOza, Saumil _954168 |
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| 700 |
_aFeldman, Leon _954169 |
||
| 700 |
_aSadhu, Ashish _954170 |
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| 700 |
_aDeLurgio, David _954171 |
||
| 773 | 0 |
_022717 _922648 _dMassachusetts NEJM Group _oNEJM011 _tThe New England Journal of Medicine _wESSALUD _x0028-4793 |
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| 942 |
_cARTICULOS _e2026-08-19 _zsqb |
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| 999 |
_c22833 _d22833 |
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