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CHAMPION-AFAtrial FibrillationNew England Journal of Medicine

Left Atrial Appendage Closure or Anticoagulation for Atrial Fibrillation

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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

Saibal KarSaibal KarPresenting authorStructural Heart / Atrial FibrillationShephal K. DoshiShephal K. DoshiElectrophysiologyDNDevi G. NairElectrophysiologyTWThomas WaggonerInterventional / Structural Cardiology

Discussion

Key questions

No takes yet. Share an insight, caveat, or question.

Where experts stand

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.

Main debate

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.

First-line alternative validated2
The data support offering the device as a reasonable alternative to blood thinners through shared decision-making.
vs
Non-inferiority win is not enough3
The trial was designed to be positive and does not convincingly clear the evidence bar set by prior studies.
Still unclear

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.

Key expert perspectives

JMJohn MandrolaCardiac electrophysiologist, Baptist Health LouisvilleEndpoint critiqueMar 31

The trial was designed to be positive before it enrolled a single patient

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.

Distilled from their postOriginal post
Sanjay KaulSanjay KaulCardiologist, Cedars-Sinai, Los Angeles, CAEndpoint critiqueMar 29

A win on the scoreboard but a loss for meaningful therapeutic value

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.

Distilled from their postOriginal post
Saibal KarSaibal KarInterventional cardiologist, Los Robles Health System, Thousand Oaks, CAPractice takeMar 31

LAAC is a reasonable first-line alternative that fits into shared decision-making

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.

Distilled from 5 of their postsOriginal postOriginal postOriginal postOriginal postOriginal post

Implication

Supports LAAC as alternative in anticoagulation-eligible AF; extends head-to-head RCT evidence versus contemporary NOACs.

Key Points

  • To evaluate the efficacy and safety of left atrial appendage closure compared to anticoagulant therapy in patients with atrial fibrillation.
  • International, randomized trial involving atrial fibrillation patients suitable for anticoagulation.
  • Patients were randomly assigned in a 1:1 ratio to receive device-based closure or NOAC therapy.
  • Follow-up duration was 3 years, assessing primary efficacy and safety endpoints.
  • At 3 years, primary efficacy events occurred in 5.7% of the device group and 4.8% of the anticoagulation group (P<0.001 for noninferiority).
  • Non-procedure-related bleeding occurred in 10.9% of the device group and 19.0% of the anticoagulation group (hazard ratio 0.55, P<0.001 for superiority).

Study Design

Type

RCT

Structured PICO

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?

P
Population
Patients with atrial fibrillation who were candidates for anticoagulation
I
Intervention
Device-based left atrial appendage closure
C
Comparator
NOAC (non-vitamin K antagonist oral anticoagulant) therapy
O
Outcome
Composite of death from cardiovascular causes, stroke, or systemic embolism at 3 yearscomposite

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.

Cite This Study

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.

synapsesocial.com/papers/69ccb55116edfba7beb8740ehttps://doi.org/10.1056/nejmoa2517213

Topics

Left atrial appendage closureAtrial fibrillationAnticoagulation in AFPersistent AF managementAF ablation outcomes
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