BACKGROUND: 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. (Funded by Boston Scientific; CHAMPION-AF ClinicalTrials.gov number, NCT04394546.).
| Discipline Area | Score |
|---|---|
| Internal Medicine |  |
| Cardiology |  |
| Hemostasis and Thrombosis | Coming Soon... |
This has the opposite conclusion from the CLOSURE-AF trial published in NEJM on 3/18/26. An electrophysiologist should write a commentary to guide clinicians debating discordant results.
The device was a little worse for events, but "non-inferior" and had less bleeding. Still not an easy choice.
This RCT shows that left atrial appendage closure is non-inferior to NOACs for major cardiovascular outcomes and reduces bleeding. It addresses a key clinical question in atrial fibrillation management, and findings are directly and highly clinically relevant to practice. However, results should be interpreted cautiously. The non-inferiority margin was relatively generous, event rates were lower than expected, there was a numerically higher stroke rate in the device group, cross-over was substantial, and the trial is industry-sponsored.
I am a primary care clinical resident doctor who encounters more ambulatory adults <70 years old or long-term care patients >80 years old. Based on the findings of this study on atrial fibrillation among adults >71.5 years old (+/- 7.5 years), the singular benefit is suggested by the non-inferior (95% confidence limits including one) probability of Kaplan-Meier estimates obtained for left atrial appendage closure vs. non-vitamin K antagonist oral anticoagulants. The researchers suggest a benefit that left atrial appendage closure results in fewer bleeding episodes and reduced death events when compared to oral anticoagulation alone, three years after the procedure is done (p<0.001).
Percutaneous left atrial appendage closure is clinically an alternative to anticoagulation in anticoagulated patients who suffer ischemic or hemorrhagic events, or in very high-risk patients. The CHAMPION-AF trial evaluates percutaneous left atrial appendage closure using a Watchman device (Boston Scientific) for the procedure, compared to anticoagulant therapy in patients with atrial fibrillation. This industry-sponsored study found that the device is a non-inferior alternative to direct oral anticoagulation (DOAC) in AF patients for the main cardiovascular outcomes, and is also associated with a lower bleeding rate during the 3-year follow-up. The trial provides evidence of a notable reduction in the bleeding rate attributable to anticoagulation, although ischemic events (strokes) were more frequent. // ORIGINAL COMMENT TRANSLATED BY AI: El cierre percutáneo de la orejuela izquierda clinicamente resulta una alternativa a la anticoagulación en pacientes anticoagulados que sufren eventos isquémicos o hemorrágicos o en pacientes de muy alto riesgo
CHAMPION-AF valora el cierre percutáneo de la orejuela izquierda mediante un dispositivo Watchman (Boston Scientific) para el procedimiento, frente al tratamiento anticoagulante en pacientes con fibrilación auricular
Se trata de un estudio promovido por la industria que comercializa el dispositivo, su resultado, es una alternativa no inferior a la anticoagulación con ACOD en pacientes con FA para los principales resultados cardiovasculares, asociando además una menor tasa de sangrados durante el seguimiento a los 3 años
El ensayo aporta evidencia, con una reducción notable de la tasa de sangrados atribuibles a la anticoagulación, aunque con eventos isquémicos (ictus) más frecuentes