Table 1.
Patient baseline characteristics
| Standardized mean differences for comparison of | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All (N = 236) | PFO-closure (n = 146) | MTA (n = 90) | PFO-closure ≤60 years + high-risk PFO (n = 103) |
PFO-closure > 60 years + high-risk PFO (n = 43) |
MTA ≤60 years + high-risk PFO (n = 20) |
MTA > 60 years + high-risk PFO (n = 28) |
MTA ≤60 years + low-risk PFO (n = 18) |
MTA > 60 years + low-risk PFO (n = 24) |
PFO-closure > 60 vs. ≤60 years | PFO-closure vs. MTA in high-risk PFO ≤60 years |
PFO-closure vs. MTA in high-risk PFO > 60 years |
low-risk vs. high-risk PFO | |
| Age, yearsa,b | 58 (47–66), 18–88 | 53 (45–62), 18–82 | 64 (52–75), 33–88 | 49 (40–54), 18–60 | 66 (63–73), 61–82 | 53 (41–58), 33–60 | 75 (69–79), 61–88 | 51 (47–55), 33–66 | 70 (65–76), 61–86 | 2.78 | 0.30 | 0.94 | 0.48 |
| Sex, femalec | 91 (38.6) | 59 (40.4) | 32 (36) | 45 (43.7) | 14 (33) | 9 (45) | 9 (32) | 7 (39) | 7 (29) | 0.23 | 0.03 | 0.01 | 0.13 |
| Pre-stroke mRS 0c | 221 (93.6) | 138 (94.5) | 83 (92) | 100 (97.1) | 38 (88) | 20 (100) | 25 (89) | 16 (89) | 22 (92) | 0.34 | 0.25 | 0.03 | 0.15 |
| Medical history | |||||||||||||
| Hypertensionc | 117 (49.6) | 73 (50.0) | 44 (49) | 41 (39.8) | 32 (74) | 4 (20) | 19 (68) | 7 (39) | 14 (58) | 0.75 | 0.44 | 0.15 | 0.01 |
| History of smokingc | 56 (23.7) | 37 (25.3) | 19 (21) | 33 (32.0) | 4 (9) | 5 (25) | 5 (18) | 7 (39) | 2 (8) | 0.59 | 0.16 | 0.25 | 0.07 |
| Hyperlipidemiac | 62 (26.3) | 37 (25.3) | 25 (28) | 24 (23.3) | 13 (30) | 3 (15) | 6 (21) | 5 (28) | 11 (46) | 0.16 | 0.21 | 0.20 | 0.32 |
| Obesityc | 26 (11.0) | 17 (11.6) | 9 (10) | 12 (11.7) | 5 (12) | 1 (5) | 2 (7) | 3 (17) | 3 (13) | < 0.01 | 0.24 | 0.15 | 0.12 |
| Diabetesc | 26 (11.0) | 9 (6.2) | 17 (19) | 5 (4.9) | 4 (9) | 2 (10) | 6 (21) | 3 (17) | 6 (25) | 0.17 | 0.20 | 0.34 | 0.36 |
| CAD and/or prior MIc | 15 (6.4) | 5 (3.4) | 10 (11) | 5 (4.9) | 0 (0) | 0 (0) | 2 (7) | 2 (11) | 6 (25) | 0.32 | 0.32 | 0.39 | 0.50 |
| Prior IS/TIAc | 30 (12.7) | 18 (12.3) | 12 (13) | 8 (7.8) | 10 (23) | 2 (10) | 4 (14) | 3 (17) | 3 (13) | 0.44 | 0.08 | 0.23 | 0.06 |
| Brain imaging | |||||||||||||
| Acute ischemic lesions in multiple circulationsc | 15 (6.4) | 7 (4.8) | 8 (9) | 5 (4.9) | 2 (5) | 1 (5) | 4 (14) | 2 (11) | 1 (4) | 0.01 | 0.01 | 0.33 | 0.04 |
| Echocardiography | |||||||||||||
| Small shuntc | 28 (11.9) | 10 (6.8) | 18 (20) | 8 (7.8) | 2 (5) | 0 (0) | 1 (4) | 6 (33) | 11 (46) | 0.14 | 0.93 | 0.18 | 2.42 |
| Moderate shuntc | 65 (27.5) | 32 (21.9) | 33 (37) | 23 (22.3) | 9 (21) | 0 (0) | 8 (29) | 12 (67) | 13 (54) | ||||
| Large shuntc | 143 (60.6) | 104 (71.2) | 39 (43) | 72 (69.9) | 32 (74) | 20 (100) | 19 (68) | 0 (0) | 0 (0) | ||||
| ASAc | 99 (41.9) | 75 (51.4) | 24 (27) | 47 (45.6) | 28 (65) | 3 (15) | 21 (75) | 0 (0) | 0 (0) | 0.40 | 0.71 | 0.22 | 1.44 |
| LVEF, %d | 59.2 ± 3.6 | 59.3 ± 3.7 | 59.1 ± 3.3 | 59.5 ± 3.1 | 58.7 ± 4.9 | 60.0 ± 0.0 | 57.7 ± 5.0 | 60.0 ± 0.0 | 59.4 ± 3.1 | 0.19 | 0.24 | 0.21 | 0.17 |
| Qualifying event | |||||||||||||
| ISc | 187 (79.2) | 119 (81.5) | 68 (76) | 87 (84.5) | 32 (74) | 15 (75) | 23 (82) | 13 (72) | 17 (71) | 0.25 | 0.24 | 0.19 | 0.22 |
| TIAc | 49 (20.8) | 27 (18.5) | 22 (24) | 16 (15.5) | 11 (26) | 5 (25) | 5 (18) | 5 (28) | 7 (29) | ||||
| Admission NIHSSa | 1 (0–4) | 1 (0–4) | 1 (0–4) | 1 (0–4) | 2 (0–4) | 1 (0–2) | 1 (0–3) | 3 (0–6) | 1 (0–5) | 0.07 | 0.36 | 0.02 | 0.23 |
| D-dimers > 0.5 μg/mLc | 47 (19.9) | 26 (17.8) | 21 (23) | 18 (17.5) | 8 (19) | 2 (10) | 9 (32) | 2 (11) | 8 (33) | 0.03 | 0.22 | 0.32 | 0.12 |
| Deep vein thrombosis or pulmonary embolismc | 12 (5.1) | 7 (4.8) | 5 (6) | 4 (3.9) | 3 (7) | 2 (10) | 1 (4) | 1 (6) | 1 (4) | 0.14 | 0.24 | 0.15 | 0.02 |
| RoPE scorea | 5 (4–7) | 6 (4–7) | 5 (3–6) | 7 (5–8) | 4 (3–5) | 7 (6–7) | 3 (3–4) | 6 (5–7) | 4 (3–5) | 2.01 | 0.05 | 0.30 | 0.52 |
ASA atrial septal aneurysm, CAD coronary artery disease, IS ischemic stroke, LVEF left ventricular ejection fraction, MI myocardial infarction, mRS modified Rankin Scale score, MTA medical therapy alone, n/a not applicable, NIHSS National Institutes of Health Stroke Scale score, PFO patent foramen ovale, RoPE Risk of Paradoxical Embolism, TIA transient ischemic attack
amedian (interquartile range), brange, cnumber (%), dmean ± standard deviation