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Table 2 Outcomes of patients with ‘patent foramen ovale (PFO)-closure’ and ‘medical therapy alone (MTA)’

From: Closure or medical therapy of patent foramen ovale in cryptogenic stroke: prospective case series

   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
  1. MRS modified Rankin Scale score, n/a not applicable
  2. 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