Patent Foramen Ovale
Original Trials
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CLOSURE I |
PC |
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Year |
2012 |
2013 |
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Patients |
909 |
414 |
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Mean F/U(yrs) |
2 |
4 |
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Comparator |
Antiplatelet, warfarin or both |
Antiplatelet or Anticoagulation |
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Country |
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Age Range |
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Age (Median) |
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Stroke |
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Cryptogenic Stroke exclusions |
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PFO |
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Exclusion Criteria |
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Results |
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Recurrent ischaemic stroke |
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ARR |
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NNT |
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Serious device adverse event |
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Severity of stroke |
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Subgroup |
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2017 Trials
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RESPECT |
REDUCE |
CLOSE |
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Year |
2013-2017 |
2017 |
2017 |
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Patients |
980 |
664 |
663 |
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Mean F/U(yrs) |
5.9 |
3.2 |
5.3 |
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AMPLATZER |
HELEX septal occluder |
Multiple devices |
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Comparator |
Antiplatelet or warfarin |
Antiplatelet (Aspirin, Asasantin or Clopidogrel) |
Antiplatelet or anticoagulation |
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Country |
USA |
Europe/ America |
France |
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Age Range |
18-60 |
18-59 |
16-60 |
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Age (Median) |
45.9 |
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Stroke |
Stroke within 270 days |
Within 180days |
Within 6 months |
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Cryptogenic Stroke exclusions |
· Arterial Imaging (either CT/US/MRI - >50% stenosis) · Lacunar infarct · Uncontrolled Hypertension, DM · TOE with bubble study – any other significant abnormality · Lupus A/C or anti-cardiolipin · Elevated homosysteine · Holter – recommended but not required |
· CTA (>50% stenosis) · Lacunar · Uncontrolled DM, Hypertension · Drug/alcohol abuse · Holter not routine |
· CTA or USS · ?Lacunar allowed · Holter not routine |
|
PFO |
Any Substantial shunt ~49% ASA ~35% |
Any with right to left shunt ASA not necessary 81% had mode-large shunt |
Large
shunt or ASA |
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Exclusion Criteria |
Initial stroke mRS >3 |
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Results |
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Recurrent ischaemic stroke |
3.6% vs 5.8% 0.58% vs1.07%/year |
1.4% vs 5.4% 0.39% vs 1.71%/year |
0% vs 4.9% 0% vs 0.98%/year |
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ARR |
0.49%/year 2.2% over trial |
1.32%/year ~4% over trial |
0.98%/year 4.9% over trial |
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NNT |
204 at one year 45 over trial |
76 (at one year) 25 over course of trial |
102 (at one year) 20 over 5 years |
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Serious device adverse event |
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1.4% |
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Severity of stroke |
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No difference in disabling stroke (mRS 3 or higher) |
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Subgroup |
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RESPECT (2017, NEJM):
REDUCE (2017, NEJM)
CLOSE (2017, NEJM)
Predictive score – ROPE
RESPECT trial
Definition of Lacunar stroke
· Distribution of single deep penetrating vessel
· Any of:
o History of Hypertension
o History of DM
o Age >50
o Leukoaraiosis
o