Study | Year | No. of patients (Device/medicine) | Follow-up, ys | Device closure | Medical therapy | Age, ys | Male, % | Diabetes, % | Hypertension, % | Dyslipidaemia, % | Current Smoker, % | Moderate to severe PFO, % | Atrial septal aneurysm, % | Index event of stroke, % |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
CLOSURE I | 2012 | 909 (447/462) | 2 | PFO closure (STARFlex) | Antiplatelet therapy, warfarin, or both | 45.5 | 51.8 | 7.8 | 31 | 44.1 | 15.2 | 52.9 | 36.6 | 72 |
PC Trial | 2013 | 414 (204/210) | 4.1 | PFO closure (Amplatzer) | Antiplatelet therapy or anticoagulation | 44.5 | 49.8 | 2.7 | 25.8 | 27.1 | 23.9 | 65.6 | 23.7 | 79.2 |
RESPECT | 2017 | 980 (499/481) | 5.9 | PFO closure (Amplatzer) | Antiplatelet therapy or warfarin | 45.4 | 54.7 | 7.5 | 31.4 | 39.5 | 13.3 | 75.2 | 35.6 | 100 |
CLOSE | 2017 | 473 (238/235) | 5.3 | PFO closure (Amplatzer, Intrasept, Premere, Starflex, etc.) plus antiplatelet therapy | Antiplatelet therapy | 43.4 | 59 | 2.5 | 10.7 | 13.9 | 29 | 100 | 32.8 | 100 |
Gore REDUCE | 2017 | 664 (441/223) | 3.2 | PFO closure (Helex, Cardioform) plus antiplatelet therapy | Antiplatelet therapy | 45.1 | 60.1 | 4.2 | 25.6 | NA | 13.3 | 81.3 | 20.4 | 100 |
Wahl, et al | 2012 [23] | 206 (103/103) | 9 | Amplatzer, STAR, Sideris Buttoned, etc | Antiplatelet therapy | 49.2 | 53.8 | 3.9 | 26.2 | 32.1 | 30.6 | 93.7 | 23.8 | 68.9 |
Alushi, et al | 2014 [24] | 418 (262/156) | 5.9 | Amplatzer, Cardia Star | Anticoagulant and/or antiplatelet therapy | 48.5 | 52.1 | 5 | 43.8 | 50 | 26.3 | 51.4 | 33.5 | 57.7 |
Pezzini, et al | 2016 [25] | 521 (206/315) | 3 | Amplazer | Antiplatelet therapy or warfarin | 35.3 | 47.6 | 1 | 13.8 | 20.3 | 32.5 | 20 | NA | 100 |
Casaubon, et al | 2007 [28] | 108 (47/61) | 2.7 | CardioSEAL and Amplatzer ASD Occluder | Antiplatelet therapy or warfarin | 46 | 53 | 6 | 17 | 23 | 15 | NA | 24 | 69 |
Faggiano, et al | 2012 [29] | 446 (99/347) | 4.5 | NA | Antiplatelet therapy or warfarin | 50 | 42 | NA | NA | NA | NA | 10.5 | 26.2 | 30.5 |
Horner, et al | 2013 [31] | 188 (97/79) | 2 | Amplatzer, CardiaStar, etc. plus antiplatelet therapy | Antiplatelet therapy or anticoagulation | 42.4 | 51.6 | 3.4 | 25 | 31.3 | 36.9 | NA | 12.5 | 57.4 |
Kim, et al | 2017 [32] | 158 (67/91) | 1.2 | Amplatzer, GORE Septal Occluder | Antiplatelet therapy or anticoagulation | 47.7 | 71.4 | 10.1 | 28.6 | 23.8 | 45.8 | NA | 7.1 | 86.3 |
Mazzucco, et al | 2012 [34] | 102 (50/52) | 2.1 | Amplatzer PFO Occluder, Amplatzer Cribriform occluder, BioSTAR | NA | 42.6 | 58.8 | 2 | 17.7 | 33.3 | 20.6 | NA | NA | 74.5 |
Lee, et al | 2010 [33] | 184 (22/159) | 3.5 | Amplatzer, CardioSeal | Antiplatelet therapy or anticoagulation | 41 | 72.9 | 14.9 | 46.4 | 24.9 | 36.5 | 18.2 | 10.5 | 100 |
Moon, et al | 2016 [26] | 164 (72/92) | 1.8 | Amplatzer | Antiplatelet therapy or anticoagulation | 45.3 | 76.8 | 11.6 | 34.1 | 11 | 58.5 | 71.3 | NA | 94.5 |
Mirzada, et al | 2015 [35] | 314 (151/163) | 5 | AMPLATZER, BioSTAR, Solysafe, etc | Antiplatelet therapy or anticoagulation | 54 | 62 | 6 | 29 | 22 | 15 | NA | 49 | 68 |
Schuchlenz, et al | 2005 [37] | 280 (167/113) | 2.7 | Amplatzer, CardioSEAL, STARflex | Antiplatelet therapy or anticoagulation | 44 | 53.6 | 7.1 | 18.6 | 17.1 | 11 | 65.7 | 24.6 | 37.8 |
Paciaroni, et al | 2011 [36] | 238 (121/117) | 2 | Amplatzer, PFOStar, CardioSEAL, etc | Antiplatelet therapy or anticoagulation | 42.2 | 49.6 | 2.1 | 19.7 | 19.3 | 29.8 | NA | 51.7 | 68.9 |
Thanopoulos, et al | 2006 [27] | 92 (48/44) | 2 | Amplatzer | Antiplatelet therapy | 43 | 52.2 | 3.2 | 19.6 | 27.2 | 18.5 | NA | 25 | 67.4 |
Harrer, et al | 2006 [30] | 117 (34/83) | 4.3 | Amplatzer, CardioSEAL and PFOSta | Antiplatelet therapy or anticoagulation | 51.1 | 57.3 | 4 | 23.4 | 8.1 | 21 | 19.4 | 24.2 | 67.7 |