Table 4. Randomized prospective clinical trials of percutaneous patent foramen ovale (PFO) closure.
| Parameter | Closure-I (No Benefit) |
PC trial (No Benefit) |
Respect (Inconclusive) |
Reduce (Inconclusive) |
Close (Benefit) |
Defense-PFO (Benefit) |
|---|---|---|---|---|---|---|
| Patients, number | 909 | 414 | 980 | 664 | 663 | 120 |
| Mean age, years | 46 | 44.5 | 46 | 42.2 | 43.3 | 51.8 |
| Moderate-large R->L, % | 53 | 65.6 | 48.8 | 81.3 | 100 | 53 |
| ASA, % | 36.6 | 23.7 | 35.7 | 20.6 | 32.8 | 10 |
| Antithrombotic Rx | Aspirin, OAC | APT, OAC | APT, OAC | APT | APT, OAC | APT |
| OAC, % | 34 | 31 | 25 | 0 | 28 | 0 |
| Follow-up, months | 44 | 49 | 70.8 | 38.4 | 63.6 | 24 |
| Stroke, % - M | 3.1 | 2.4 | 5.8 | 5.4 | 6.0 | 10.5 |
| Stroke, % - C | 2.9 | 0.5 | 3.6 | 1.4 | 0.0 | 0 |
| TIA, % - M | 4.1 | 3.3 | 4.8 | – | – | 2.0 |
| TIA, % - C | 3.1 | 2.5 | 3.4 | – | – | 0 |
| Death, % - M | 0 | 0 | 2.2 | 0 | 0 | 0 |
| Death, % - C | 0 | 1.0 | 1.4 | 0.5 | 0 | 0 |
The stroke prevention outcomes are highlighted for comparison, indicating whether or not their results showed benefit of closure, or if they were inconclusive. See text for additional details. APT, antiplatelet therapy; ASA, atrial septal aneurysm; C, closure arm; M, medical arm; OAC, oral anticoagulation; R->L, right-to-left shunt; Rx, regimen; TIA, transient ischemic attack.