Table 2: Randomised Trials Comparing Patent Foramen Ovale Closure with Medical Therapy.
| Study | Year | Device | n | Endpoints | Results | Comments |
|---|---|---|---|---|---|---|
| CLOSURE 1[12] | 2012 | STARFlex Septal Closure System | 909 | Composite of death (0–30 days), neurological death (≥31 days), stroke or TIA at 2-year follow-up | Non-significant reduction in primary endpoint (HR 0.78; 95% CI [0.45–1.35] p=0.37) |
Left atrial thrombus formation in closure
group Inadequate closure at 2 years |
| PC Trial[13] | 2013 | Amplatzer PFO Occluder | 414 | Composite of death, stroke, TIA or peripheral embolism at 4,5 years | Non-significant reduction in primary endpoint (HR 0.63; 95% CI [0.24–1.62]; p=0.34) |
Underpowered trial High volume of crossover to PFO closure during follow-up |
| RESPECT[18,19] | 2013 Long-term data published in 2017 |
Amplatzer PFO Occluder | 980 | Composite of early death, stroke or TIA | Non-significant reduction in primary endpoint at
median follow-up 2.1 years (HR 0.49; 95% CI [0.22–1.11]; p=0.08) Long-term follow-up (median 5.9 years) showed significant reduction with closure (HR 0.55; 95% CI [0.31–0.99]; p=0.046) |
As treated analysis shows a benefit in favour of closure even at the early timepoint. |
| CLOSE[22] | 2017 | 11 approved devices (Amplatzer PFO Occluder >50%) | 663 | Fatal or non-fatal stroke | Significant reduction in stroke with occlusion
compared with antiplatelet therapy only (HR 0.03, 95% CI [ 0-0.26]; p<0.001) |
1:1:1 randomisation PFO closure versus antiplatelets versus anti-coagulation |
| Gore REDUCE[20] | 2017 | Helex Septal Occluder or Cardioform Septal Occluder | 664 | Co-primary endpoints of clinical stroke and incidence of new brain infarction | Significant reduction in clinical stroke at median
follow-up 3.2 years (HR 0.23; 95% CI [0.09–0.62]; p=0.002) Significant reduction in new brain infarction (RR 0.51; 95% CI [0.29–0.91]; p=0.04) |
2:1 randomisation to PFO closure |
| DEFENSE PFO[21] | 2018 | Amplatzer PFO Occluder | 120 | Stroke, vascular death or Major bleeding at 2-year follow-up | Significant reduction in primary endpoint with PFO closure. No events in PFO closure arm versus 12.9% 2-year event rate in medication only arm (p=0.013) |
PFO = patent foramen ovale; TIA = transient ischaemic attack.