Does Left Atrial Appendage Closure Reduce Mortality? A Vital Status Analysis of the Randomized PROTECT AF and PREVAIL

William Whang1, David R Holmes2, Marc A Miller1

  • 1Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Insights

Left atrial appendage closure (LAAC) significantly improved survival by 30% compared to warfarin in patients with atrial fibrillation. The number needed to treat with LAAC to prevent one death was 16 over five years.

Area of Science:

  • Cardiology
  • Medical Devices
  • Clinical Trials

Background:

  • Left atrial appendage closure (LAAC) is an alternative to warfarin for stroke prevention in atrial fibrillation.
  • Previous analyses of the PROTECT AF and PREVAIL trials suggested a mortality benefit with LAAC.
  • Limitations included significant patient drop-out, necessitating updated vital status information.

Purpose of the Study:

  • To estimate the mortality benefit of LAAC compared to warfarin using updated vital status data.
  • To re-evaluate survival outcomes in patients from the PROTECT AF and PREVAIL trials.

Main Methods:

  • Utilized updated vital status information for subjects with incomplete 5-year follow-up from the PROTECT AF and PREVAIL trials.
  • Manually queried centers for vital status on 76 subjects (33% of drop-outs).
  • Analyzed all-cause mortality data during a median follow-up of 5.0 years.

Main Results:

  • LAAC was associated with a 30% improvement in survival compared to warfarin (Hazard Ratio: 0.70; 95% CI: 0.53-0.94; p=0.017).
  • The number needed to treat (NNT) with LAAC to prevent one death over 5 years was 16 (95% CI: 10-82).
  • Subgroup analyses indicated potential greater benefit in younger patients (<75 years) and those with higher CHA2DS2-VASc scores or prior stroke/TIA.

Conclusions:

  • Updated vital status data confirm that LAAC is associated with significantly improved survival compared to warfarin.
  • LAAC offers a survival advantage in patients with atrial fibrillation, even in the presence of competing mortality risks.
  • The findings support LAAC as an effective therapeutic option for reducing mortality in select atrial fibrillation populations.

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