Table 1.
Baseline patient characteristics of included trials.
| Characteristics | CLOSE (2017)12 |
REDUCE (2017)13 |
RESPECT (2017)6 |
PC trial (2013)5 |
CLOSURE I (2012)4 |
|||||
|---|---|---|---|---|---|---|---|---|---|---|
| PFO closure | MT | PFO closure | MT | PFO closure | MT | PFO closure | MT | PFO closure | MT | |
| Device used | Amplatzer | Helex/GSO | Amplatzer | Amplatzer | StarFLEX | |||||
| Number | 238 | 235 | 441 | 223 | 499 | 481 | 204 | 210 | 447 | 462 |
| Duration of follow-up (years) | 5.2 | 5.4 | 3.2 | 3.2 | 6.2 | 5.6 | 4.1 | 4 | 2 | 2 |
| Age: mean (years) | 42.9 | 43.8 | 45.4 | 44.8 | 45.7 | 46.2 | 44.3 | 44.6 | 45.3 | 45.7 |
| Male sex | 58% | 60% | 59% | 62% | 54% | 56% | 45% | 54% | 52% | 52% |
| Cardiovascular risk factors | ||||||||||
| Smoking (%) | 29 | 29 | 14 | 11 | 15 | 11 | 26 | 22 | 22 | 23 |
| Diabetes mellitus (%) | 1 | 4 | 4 | 5 | 7 | 9 | 3 | 3 | NR | NR |
| Hyperlipidemia (%) | 13 | 15 | NR | NR | 39 | 41 | 25 | 30 | 47 | 41 |
| Hypertension (%) | 11 | 10 | 25 | 26 | 32 | 32 | 24 | 28 | 34 | 28 |
| Coronary artery disease (%) | NA | NA | NA | NA | 3.8 | 1.9 | 2 | 1.9 | 1.3 | 0.9 |
| Two or more prior strokes (%) | 4.2 | 3 | 9.5 | 5.8 | 10.6 | 10.6 | 37.3 | 37.6 | NA | NA |
| Interatrial septal aneurysm (%) | 34 | 31.5 | 20.4 | NA | 36.1 | 35.3 | 23 | 24.3 | 37.6 | 35.7 |
| PFO characteristics | ||||||||||
| Atrial septal aneurysm (%) | 34 | 31 | 20 | NR | 36 | 35 | 23 | 24 | 38 | 36 |
| Outcomes | ||||||||||
| Atrial fibrillation (%) | 4.84 | 0.85 | 7.03 | 0.45 | 0.8 | 0.63 | 3.3 | 0.96 | 6.07 | 0.66 |
| Stroke (%) | 0 | 6.33 | 1.37 | 5.68 | 1.83 | 3.44 | 0.49 | 2.43 | 2.76 | 2.89 |
| Transient ischemic attacks (%) | 3.47 | 3.52 | 4.01 | 3.72 | 1.22 | 0.84 | 2.51 | 3.45 | 2.99 | 3.82 |
PFO: patent foramen ovale; MT: medical therapy; NR: Not reported; NA: Not available; GSO: Gore Septal occluder.