Table 2.
Outcomes of patients with ‘patent foramen ovale (PFO)-closure’ and ‘medical therapy alone (MTA)’
| p for comparison of | Relative risk (95% confidence interval) 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 | |
| Ischemic strokea | 7 (3.0) | 6 (4.1) | 1 (1) | 3 (2.9) | 3 (7) | 0 (0) | 1 (4) | 0 (0) | 0 (0) | 0.36 | 1.41 (0.08–26.36)§ | 1.95 (0.21–17.85) | 0.30 (0.02–5.19)§ |
| Intracranial hemorrhagea | 0 (0.0) | n/a | |||||||||||
| Transient ischemic attacka | 6 (2.5) | 6 (4.1) | 0 (0) | 3 (2.9) | 3 (7) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0.36‡ | 1.41 (0.08–26.36)§ | 4.61 (0.25–86.05)§ | 0.35 (0.02–6.08)§ |
| Systemic embolisma | 0 (0.0) | n/a | |||||||||||
| Myocardial infarctiona | 3 (1.3) | 2 (1.4) | 1 (1) | 1 (1.0) | 1 (2) | 0 (0) | 1 (4) | 0 (0) | 0 (0) | 0.50‡ | 0.61 (0.03–14.37)§ | 0.65 (0.04–9.99) | 0.65 (0.03–12.31)§ |
| Death from any causea | 10 (4.2) | 2 (1.4) | 8 (9) | 1 (1.0) | 1 (2) | 0 (0) | 4 (14) | 1 (6) | 3 (13) | 0.50‡ | 0.61 (0.03–14.37)§ | 0.16 (0.02–1.38) | 3.08 (0.91–10.43) |
| New-onset atrial fibrillationa | 1 (0.4) | 1 (0.7) | 0 (0) | 0 (0.0) | 1 (2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0.29‡ | n/a | 1.98 (0.08–46.89)§ | 1.51 (0.06–36.48)§ |
| Major Bleedingsa | 0 (0.0) | n/a | |||||||||||
| Major or clinically relevant non-major bleedingsa | 0 (0.0) | n/a | |||||||||||
| PFO-unrelated outcome eventsa | 14 (5.9) | 5 (3.4) | 9 (10) | 2 (1.9) | 3 (7) | 0 (0) | 5 (18) | 1 (6) | 3 (13) | 0.15‡ | 1.01 (0.05–20.28)§ | 0.49 (0.12–2.02) | 2.05 (0.66–6.35) |
| MRS at follow-up 0 or 1a | 198 (83.9) | 129 (88.4) | 69 (77) | 96 (93.2) | 33 (77) | 20 (100) | 19 (68) | 0 (0–1) | 0 (0–2) | 0.01‡ | 3.03 (0.18–51.02)§ | 0.72 (0.34–1.55) | 2.13 (1.17–3.87) |
| Standardized mean differences | |||||||||||||
| Follow-up time (days)b | 1016 ± 479 | 1013 ± 471 | 1021 ± 494 | 1061 ± 471 | 899 ± 455 | 1114 ± 433 | 878 ± 474 | 993 ± 457 | 1131 ± 570 | 0.35 | 0.12 | 0.05 | 0.14 |
MRS modified Rankin Scale score, n/a not applicable
anumber (%), bmean ± standard deviation, ‡secondary outcomes: after Bonferroni adjustment, p < 0.005 is considered significant, §0.5 was added to each group if zero events in one group