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Published on: March 15, 2020
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.
Abstract:
Compared with warfarin, left atrial appendage closure (LAAC) reduced mortality in an analysis of the PROTECTAF and PREVAIL trials. However, these data were limited by patient drop-out.We sought to estimatethe mortality benefit with LAACusing updated vital status information.In PROTECT AF and PREVAIL, 227 of 1114 randomized subjects failed to complete 5-year follow-up. Centers were manually queried for updated vital status on 76 subjects (33%).During median follow-up 5.0 years (interquartile range 3.8, 5.1), 112 of 732 LAAC subjects (15.3%) and 79 of 382 controls (20.7%) died. The hazard ratio for all-cause mortality with LAAC compared with warfarin was 0.70 (95% CI 0.53-0.94, p=0.017).Subgroup analyses suggested that subjects <75 years and those with higher CHA2DS2-VASc score, history of transient ischemic attack or stroke, and permanent AF derived particular benefit, although interaction terms were not significant.The number needed to treat(NNT) with LAAC to prevent one death over 5 years was 16 (95% CI 10-82). Despite competing mortality risks in this elderly cohort, updated vital status data from PROTECT AF and PREVAIL revealed that LAAC was associated with 30% improved survival compared with warfarin, with an NNT of 16.
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