Percutaneous left atrial appendage closure for stroke prevention in patients with atrial fibrillation: an assessment of net clinical benefit
Why the study?
Does percutaneous LAA closure improve net clinical benefit compared to sustained anticoagulation in adults with non-valvular atrial fibrillation?
Population
1,273 adults with non-valvular atrial fibrillation (707 from the PROTECT-AF trial and 566 from the Continued…
Comparison
Percutaneous left atrial appendage closure with… vs Sustained anticoagulation (warfarin)
Design
Cohort
Follow-up
1623 person-years in the trial and 741 patient-years in…
Authors
Discussion
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Member takes
Implication
Supports greater net benefit in higher CHADS2 AF; hypothesis-generating and requires prospective RCTs versus contemporary anticoagulation.
Key Points
- To estimate the net clinical benefit of percutaneous left atrial appendage closure compared with sustained anticoagulation in patients with non-valvular atrial fibrillation.
- Conducted a post hoc analysis of 707 patients from the randomized PROTECT-AF trial (1,623 person-years) and 566 from the Continued Access registry (741 patient-years) receiving the Watchman device versus sustained warfarin.
- Calculated net clinical benefit by weighting annualized rates of ischaemic stroke, intracranial haemorrhage, major bleeding, pericardial effusion, and death by their severity regarding death and disability.
- Annualized net clinical benefit of left atrial appendage closure was 1.73%/year (95% CI: -0.54 to 4.39%/year) in the randomized trial and 4.97%/year (95% CI: 3.07 to 7.15%/year) in the registry.
- Patients with previous ischaemic stroke experienced higher net benefit in both the trial (4.30%/year, 95% CI: -2.07 to 11.25%/year) and registry (8.68%/year, 95% CI: 2.82 to 14.92%/year).
- Registry outcomes showed net clinical benefit expanded from 2.22%/year (95% CI: 0.27 to 6.01%/year) in patients with CHADS2 scores of 1 to 6.12%/year (95% CI: 3.19 to 8.92%/year) in those with scores ≥2.
Structured PICO
Does percutaneous LAA closure improve net clinical benefit compared to sustained anticoagulation in adults with non-valvular atrial fibrillation?
P
Population
1,273 adults with non-valvular atrial fibrillation (707 from the PROTECT-AF trial and 566 from the Continued Access (CAP) registry)
I
Intervention
Percutaneous left atrial appendage (LAA) closure with the Watchman device
C
Comparator
Sustained anticoagulation (warfarin)
O
Outcome
Net clinical benefit (NCB) calculated as the sum of annualized rates of ischaemic stroke, intracranial haemorrhage, major bleeding, pericardial effusion, and death, weighted to reflect relative impactcomposite
Percutaneous LAA closure provides a positive net clinical benefit compared to warfarin in patients with non-valvular AF, particularly in those with higher stroke risk.
Cite This Study
Gangireddy et al. (2012) studied this question.