Key result
LAAC proves noninferior to NOACs for major events and reduces non-procedure-related bleeding at 3 years.
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?
Population
Patients with atrial fibrillation who were candidates for anticoagulation
Comparison
Device-based left atrial appendage closure vs NOAC therapy
Follow-up
3 years
Authors
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Experts are sharply split on whether CHAMPION-AF justifies offering LAAC as a first-line alternative to NOACs, with skeptics calling the non-inferiority win a product of trial design rather than a meaningful clinical advance.
CHAMPION-AF met its non-inferiority endpoint and showed less bleeding with the device, but the cardiology community is divided on what that means for practice. Trial investigators frame the result as a milestone that opens LAAC to a broader population, while independent cardiologists and electrophysiologists argue the bar was set too low and that prior conflicting data from CLOSURE-AF undercuts the case. The live question is whether guidelines will treat this as sufficient evidence to position the device as first-line therapy alongside NOACs.
Investigators call LAAC a legitimate first-line alternative to NOACs. Independent voices say the trial was designed to win and the evidence bar has not been met.
Whether guidelines will update to include LAAC as a first-line option or continue to reserve it for patients who cannot tolerate anticoagulation. How to reconcile CHAMPION-AF with the conflicting bleeding signal from CLOSURE-AF, which showed more bleeding in the device arm. Whether the net clinical benefit difference will hold in longer follow-up or in real-world populations outside trial conditions.
Mandrola argues that oral anticoagulation for AF is one of the most evidence-based practices in medicine and that much stronger data would be needed to displace it. He warns clinicians not to be "bamboozled" by a trial he sees as engineered to deliver a win.
Kaul sees the result as reflecting clever protocol design rather than breakthrough efficacy. He argues the trial was structured to deliver a positive outcome, which undermines confidence in the clinical significance of the findings.
Kar, a trial investigator, argues the data support the device as a potential alternative to medication even in patients suitable for long-term blood thinners. He notes consistency with prior trials and real-world registry data, while acknowledging that CLOSURE-AF showed more bleeding in the device arm likely due to procedural factors.
Supports LAAC as alternative in anticoagulation-eligible AF; extends head-to-head RCT evidence versus contemporary NOACs.
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.
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.
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