Flecainide to Prevent Atrial Arrhythmia After Patent Foramen Ovale Closure: AFLOAT Study, A Randomized Clinical Trial

doi:10.1161/circulationaha.124.071186

Valvular & structural heart disease

Flecainide to Prevent Atrial Arrhythmia After Patent Foramen Ovale Closure: AFLOAT Study, A Randomized Clinical Trial

CirculationPublished 2 Sep 2024Randomised controlled trial

Primary result · Atrial arrhythmia (≥30 seconds)ResultRisk difference 1.4% 95% CI −12.9% to 13.8%

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Authors' conclusion

Flecainide did not prevent AA after PFO closure.

Study context

Population: Patients after patent foramen ovale (PFO) closure
Participants: 186 patients

Comparison: Flecainide for 3 or 6 months vs standard of care after PFO closure
Flecainide 3 monthsn = 63
Flecainide 6 monthsn = 60
Standard of caren = 63reference
Primary endpoint: ≥1 episode of atrial arrhythmia (≥30 seconds) on insertable cardiac monitor
Follow-up: Within 3 months after PFO closure

Methodological detailsprospective, multicentre, open-label, superiority, blinded end point evaluation (PROBE), 1:1:1 randomisation

Prospective
Multicentre
Open-label
Superiority
Blinded end point evaluation (PROBE)
1:1:1 randomisation

Primary result

Atrial arrhythmia (≥30 seconds)

Risk difference

1.4%

95% CI −12.9% to 13.8%

NS

Events by treatment group

Flecainide ≥3 months26.8%33 events

Standard of care25.4%16 of 63

Flecainide ≥3 months vs Standard of care

risk difference 1.4% (95% CI −12.9% to 13.8%); NS

As reported in the abstract

Secondary outcomes

Outcome	Flecainide 3 months	Flecainide 6 months	Standard of care	← Lower vs standard of care ←→ Higher vs standard of care →	Risk difference (95% CI)
Atrial arrhythmia (≥30 seconds) · 3- to 6-month period after PFO closure — Flecainide 6 months vs Standard of care	6.3%	5.0%	7.9%	−20−10010	−2.9% (−12.7% to 6.9%)
Atrial arrhythmia (≥30 seconds) · 3- to 6-month period after PFO closure — Flecainide 3 months vs Standard of care				−20−10010	−1.6% (−11.8% to 8.6%)
				−20−10010Difference (linear scale)

Atrial arrhythmia (≥30 seconds), all patients · 6-month follow-up

Atrial arrhythmia (AA) in all patients: 53 (28.5%)
AA events in first month after PFO closure: 86.8%

Original publication

Flecainide to Prevent Atrial Arrhythmia After Patent Foramen Ovale Closure: AFLOAT Study, A Randomized Clinical Trial. Circulation. Published 2 September 2024. doi:10.1161/circulationaha.124.071186

Read the original article ↗PubMed

Summarised from the published abstract; every number is checked against it