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August 28, 2026European Heart Journal - Quality of Care and Clinical OutcomesOpen Access

Noninferiority as a Moving Target in LAAC Trials

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Key result

Noninferiority margins in left atrial appendage closure trials represent a moving target for evaluating clinical outcomes.

Authors

ACAlberto CeredaMSM StracqualursiAFAntonio Gabriele Franchina

Discussion

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Overview

Methodological review reveals shifting noninferiority margins in left atrial appendage closure trials, indicating a need for standardized statistical benchmarks.

Key Points

  • Examine the variability and methodological challenges of noninferiority margins in clinical trials assessing left atrial appendage closure.
  • Reviewed noninferiority trial designs and statistical margin definitions across clinical investigations of left atrial appendage closure devices.
  • Identified variability in noninferiority margin selection when comparing device closure to medical anticoagulation.
  • Highlighted the risk of inconsistent clinical interpretations resulting from shifting statistical thresholds across trials.

Cite This Study

Cereda et al. (2026) studied this question. Noninferiority margins in left atrial appendage closure trials represent a moving target for evaluating clinical outcomes.

synapsesocial.com/papers/6a9145c5d15324a1df3a90bfhttps://doi.org/10.1093/ehjqcco/qcag137
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