Left atrial appendage closure is noninferior to oral anticoagulation after ablation for atrial fibrillation

1. In this randomized trial, left atrial appendage closure was associated with lower bleeding than oral anticoagulation in patients who underwent catheter-based atrial fibrillation ablation. 

2. Left atrial appendage closure was noninferior to oral anticoagulation concerning composite of death from any cause, stroke, or systemic embolism at 36 months. 

Evidence Rating Level: 1 (Excellent)

Study Rundown: Catheter ablation is an effective strategy for treating symptomatic atrial fibrillation. However, given that atrial fibrillation has a high risk of recurrence, indefinite continuation of oral anticoagulation is recommended for patients who are at high risk of stroke. Anticoagulation carries important limitations, such as risk of bleeding, patient anxiety, and cost considerations. Catheter-based left atrial appendage closure provides an alternative strategy to anticoagulation for stroke prevention. The purpose of this randomized trial was to determine whether left atrial appendage closure can safely decrease the risk of bleeding associated with oral anticoagulants while maintaining a lower stroke risk in patients who are at risk of stroke and have had a catheter ablation for atrial fibrillation. Patients who met the inclusion criteria were randomly assigned in a 1:1 ratio to undergo left atrial appendage closure or receive anticoagulation. The primary efficacy end point tested for noninferiority was a composite of death from any cause, stroke, or systemic embolism at 36 months. Results from this study found that left atrial appendage closure was associated with a lower risk of bleeding than anticoagulation among patients who underwent catheter-based ablation for atrial fibrillation. Additionally, left atrial appendage closure was noninferior to anticoagulation with respect to all-cause death, stroke, or systemic embolism. Limitations of this study include the exclusion of patients with left ventricular ejection fraction less than 30, the open-label design, and the type of ablation technology used.

Click here to read the study in NEJM

In-Depth [randomized controlled trial]: This randomized trial aimed to determine whether left atrial appendage closure can safely decrease the risk of bleeding associated with oral anticoagulants while maintaining a low risk of stroke among patients who have undergone catheter ablation for atrial fibrillation and are at high risk of stroke. Patients with atrial fibrillation who underwent catheter ablation in the past 90-180 days before randomization and had a CHA2DS2-VASc score of at least two for men and three for women were eligible for randomization. A total of 1,600 patients were randomly assigned in a 1:1 ratio to either undergo left atrial appendage closure (n=803) or receive anticoagulant therapy (n=797). The primary safety end point for this study tested for superiority and was non-procedure related major bleeding or clinically relevant non-major bleeding. The primary efficacy end point was tested for noninferiority in the composite of all-cause death, stroke, or systemic embolism at 36 months.  Results from this study found that at 36 months, a primary safety end point had occurred in 65 patients (8.5%) in the left atrial appendage closure group and 137 (18.1%) in the anticoagulation group (p<0.001 for superiority). A primary efficacy end point event had occurred in 41 patients (5.3%) in the left atrial appendage closure group and 44 patients (5.8%) in the anticoagulation group (p<0.001 for noninferiority). Overall, results from this study found that among patients who underwent catheter-based ablation for atrial fibrillation, left atrial appendage closure was associated with a lower risk of bleeding than oral anticoagulation. Left atrial appendage closure was also noninferior to anticoagulation with respect to a composite of death from any cause, stroke, or systemic embolism at 36 months.

Image: PD

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