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September 17, 2026Polskie Archiwum Medycyny WewnętrznejOpen Access

LAAC meets noninferiority versus medical therapy in lower-risk patients but fails in higher-risk populations.

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Why the study?

Many eligible AF patients do not receive or maintain long-term anticoagulation due to bleeding risk or contraindications, prompting evaluation of LAAC as an alternative.

Does percutaneous left atrial appendage closure (LAAC) improve clinical outcomes compared to anticoagulation or best medical therapy in patients with atrial fibrillation?

Population

Lower-risk and higher-risk AF patients with adverse bleeding profiles

Comparison

Percutaneous LAAC vs DOAC or best medical therapy

Design

Review of recent randomized trials CHAMPION-AF and CLOSURE-AF

Follow-up

Up to 3 years

Key result

Percutaneous left atrial appendage closure demonstrated mixed results compared to medical therapy, meeting noninferiority for efficacy in lower-risk patients but failing to show noninferiority in higher-risk populations.

Authors

POPavel OsmancikCharles UniversityMHMarek HozmanElectrophysiology

Discussion

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Member takes

Overview

LAAC decisions in AF require careful risk stratification; leaves open optimal use versus DOACs in higher-risk patients.

Key Points

  • To review the efficacy, safety, and clinical implications of percutaneous left atrial appendage closure compared with anticoagulation across recent randomized clinical trials.
  • Review and critical appraisal of CHAMPION-AF, which randomized 3,000 lower-risk atrial fibrillation patients to left atrial appendage closure (Watchman FLX) or direct oral anticoagulants.
  • Appraisal of CLOSURE-AF, which randomized higher-risk atrial fibrillation patients with elevated bleeding risk to left atrial appendage closure versus best medical therapy.
  • Evaluation of trial methodology, noninferiority margin selections, and bleeding-endpoint definitions to guide clinical candidate selection.
  • In CHAMPION-AF, left atrial appendage closure met noninferiority for composite cardiovascular death, stroke, and systemic embolism (5.7% vs 4.8% at 3 years; HR 1.20, 95% CI 0.87–1.66) and met superiority for non-procedure-related bleeding (10.9% vs 19.0%; HR 0.55), but ischemic stroke was numerically higher with the device (HR 1.61).
  • In CLOSURE-AF, left atrial appendage closure failed to demonstrate noninferiority for composite cardiovascular death, stroke, systemic embolism, and major bleeding compared to best medical therapy (16.8 vs 13.3 events per 100 patient-years), driven by higher mortality and bleeding in the device group.

Structured PICO

Does percutaneous left atrial appendage closure (LAAC) improve clinical outcomes compared to anticoagulation or best medical therapy in patients with atrial fibrillation?

P
Population
A review of recent randomized trials, including CHAMPION-AF and CLOSURE-AF, evaluating percutaneous left atrial appendage closure versus medical therapy in patients with atrial fibrillation.
I
Intervention
Percutaneous left atrial appendage closure (LAAC)
C
Comparator
Direct oral anticoagulants (DOACs) or best medical therapy
O
Outcome
Composite of cardiovascular death, stroke, and systemic embolism (with or without major bleeding)composite

This review highlights that while LAAC may be a noninferior alternative to DOACs in lower-risk AF patients, it failed to show noninferiority in higher-risk patients, emphasizing the need for careful patient selection.

Limitations

  • Open-label designs in LAAC trials make soft, symptom-driven bleeding endpoints susceptible to ascertainment bias.
  • Early procedural bleeding hazards may obscure potentially different bleeding risks during later follow-up if time-dependent analyses are not used.
  • Bleeding represents both a procedural complication and a clinical outcome, complicating the methodological assessment of LAAC safety.

Cite This Study

Osmancik et al. (2026) conducted a review in Atrial fibrillation. Percutaneous left atrial appendage closure (LAAC) vs. Medical therapy (primarily DOACs) was evaluated. Percutaneous left atrial appendage closure demonstrated mixed results compared to medical therapy, meeting noninferiority for efficacy in lower-risk patients but failing to show noninferiority in higher-risk populations.

synapsesocial.com/papers/6aabb7f75f706d05830e7560https://doi.org/10.20452/pamw.17402
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Left Atrial Appendage Closure versus Oral Anticoagulants in Patients with Atrial Fibrillation: Systematic Review2026
  2. 2Left Atrial Appendage Closure Versus Oral Anticoagulation for Stroke Prevention in Non-Valvular Atrial Fibrillation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials2026
  3. 3Catheter-Based Left Atrial Appendage Closure vs Oral Anticoagulation in Patients With Atrial Fibrillation2026
  4. 4Utilization of percutaneous left atrial appendage closure in patients with atrial fibrillation: an update on patient outcomes2020 · 6 citations
  5. 5Left Atrial Appendage Closure versus Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation: Long-Term Outcomes from Four Randomized Trials2025 · 24 citations