What happened
Device-based left atrial appendage closure was noninferior to NOAC therapy for cardiovascular death, stroke, or systemic embolism and superior for non-procedure-related bleeding at 3 years.
“The between-group difference in the incidence of ischemic stroke or systemic embolism that was observed in the CHAMPION-AF trial was 1 percentage point over the course of 3 years, which corresponds to a 0.3% increase per year among patients who received the device.”
Saibal Kar ↗From published coverage, not an answer posted here.
Gregory Marcus
Endpoint critiqueCardiologist, University of California, San FranciscoAfter CLOSURE-AF, the device must show at least equivalence, and CHAMPION-AF did not convincingly prove it.
Original post ↗“The success of the landmark CHAMPION-AF trial represents a meaningful milestone that will undoubtedly transform the treatment approach to stroke risk reduction in a broader population of patients who historically have needed to rely on medication. These results should give clinicians confidence in the potential of the WATCHMAN FLX device to become a first-line treatment option for reducing the risk of stroke for a rapidly growing number of patients with AF.”
News Coverage ↗
“Oral anticoagulation for AF is one of the most evidence-based practices in all of medicine. To upend that would take much stronger data. Don't be bamboozled by this trial, which was designed to be positive before the first patient was enrolled.”
News Coverage ↗
Sanjay Kaul
Cardiologist, Cedars-Sinai, Los Angeles, CA“It's a win on the scoreboard but a loss as far as delivering meaningful, reliable therapeutic value. Good trial design balances feasibility with rigor; when it's designed to deliver a win, it signals more about clever protocol writing and trial design than breakthrough efficacy.”
Expert Commentary ↗Upvote a question you would like answered, or open it to join the discussion.
Answers are grounded in this paper and cite their sources.
Why the trial, tables, limitations, PICO, abstract, media & sources
Why the trial?
Does device-based left atrial appendage closure reduce a composite of death from cardiovascular causes, stroke, or systemic embolism compared to NOAC therapy in patients with atrial fibrillation who are candidates for anticoagulation?
RCT
Does device-based left atrial appendage closure reduce a composite of death from cardiovascular causes, stroke, or systemic embolism compared to NOAC therapy in patients with atrial fibrillation who are candidates for anticoagulation?
Device-based left atrial appendage closure is a noninferior alternative to NOAC therapy for stroke prevention in atrial fibrillation, offering superior protection against non-procedure-related bleeding at 3 years.
Experts are split: trial investigators see the closure device as a reasonable first-line alternative to blood thinners, while a skeptic argues it has not yet proven itself against medication.
Supporters read the result as evidence that closing the appendage with a device can stand in for long-term blood thinners, even in patients who could take them, and suggest offering it through shared decision-making. A critic counters that another recent trial with unfavorable bleeding results raised the bar, and that this trial did not clear it. The live question is how to weigh this result against conflicting trials before treating the device as a first-line option.
Is the device ready as a first-line alternative to blood thinners, or is the proof not convincing yet?
It remains unclear how to square this result with CLOSURE-AF, where bleeding was higher in the device arm. Kar puts that down to procedure-related bleeding, and Marcus treats that trial as raising the bar the device has to clear.
Supports LAAC as alternative in anticoagulation-eligible AF; extends head-to-head RCT evidence versus contemporary NOACs.
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.).
Doshi et al. (2026) conducted an RCT in Atrial fibrillation. Device-based left atrial appendage closure vs. NOAC therapy was evaluated on Composite of death from cardiovascular causes, stroke, or systemic embolism. Device-based left atrial appendage closure was noninferior to NOAC therapy for cardiovascular death, stroke, or systemic embolism and superior for non-procedure-related bleeding at 3 years.
Synapse has enriched 10 related papers. Consider them for comparative context: