First author

Study acronym

Publication year

Country

Participants

Follow-up

HR (95% CI)

Device closure

Medical therapy

Primary endpoint

Secondary endpoint

Carroll et al.

RESPECT

2013

USA and Canada

980

2.6 ± 2.0 years

0.49 (0.22 - 1.11)

Amplatzer PFO Occluder

Aspirin, warfarin, clopidogrel, aspirin with dipyridamole, or aspirin with clopidogrel

Recurrence of fatal or nonfatal ischemic stroke, all-cause mortality

Complete closure rate, absence of recurrent cryptogenic, nonfatal TIA/stroke or cardiovascular death

Meier et al.

PC

2013

Europe, Canada, Brazil, and Australia

414

4.1 years in the closure group and 4.0 years in the medical-therapy group

0.63 (0.24 - 1.62)

Amplatzer PFO Occluder

Antiplatelet therapy or oral anticoagulation

Nonfatal stroke, TIA, peripheral embolism, and all-cause mortality

Cardiovascular death, new arrhythmias, myocardial infarction, device-related problems, and bleeding

Furlan et al.

CLOSURE I

2012

USA and Canada

909

2 years

0.78 (0.45 - 1.35)

STARFlex septal closure system

Warfarin, aspirin or both

Stroke or TIA, all-cause mortality, and death from neurologic causes

Major bleeding, death from any cause, stroke, TIA, and transient neurologic events of uncertain cause

Mas et al.

CLOSE

2017

France and Germany

663

5.3 ± 2.0 years

0.55 (0.31 - 0.999)

Eleven different devices

aspirin, clopidogrel, or aspirin with dipyridamole

Recurrence of fatal or nonfatal stroke

Ischemic stroke, TIA systemic embolism, disabling stroke; ischemic stroke, all-cause mortality, cardiovascular death

Saver et al.

RESPECT

2017

USA and Canada

980

Median of 5.9 years

0.23 (0.09 - 0.62)

Amplatzer PFO Occluder

Aspirin, warfarin, clopidogrel, or aspirin combined with dipyridamole

Recurrent nonfatal ischemic stroke, fatal ischemic stroke, or early death

Absence of recurrent cryptogenic, early cardiovascular death, absence of transient ischemic attack

Søndergaard et al.

Gore REDUCE

2017

Canada, Denmark, Finland, Norway, Sweden, the UK, and the US

664

Median of 3.2 years

0.03 (0 - 0.26)

Helex Septal Occluder and Cardioform Septal Occluder

Aspirin, aspirin with dipyridamole, clopidogrel, or clopidogrel

Recurrent ischemic stroke, all-cause mortality

New brain infarction, success of PFO closure