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 |