Summary of results from five randomised trials of PFO closure
| Trial (year) | N | PFO closure device (incidence rate) | Medical therapy (incidence rate) | HR (95% CI) | P values |
| CLOSURE-1 (2012) | 909 | STARFlex (2.6) | AP/AC (3.1) | 0.78 (0.45 to 1.35) | 0.37 |
| PC Trial (2013) | 414 | Amplatzer (0.8) | AP/AC (1.3) | 0.63 (0.24 to 1.62) | 0.34 |
| RESPECT (long term) (2017) | 980 | Amplatzer (0.6) | AP/AC (1.1) | 0.55 (0.31 to 1.0) | 0.046 |
| CLOSE (2017) | 473 | Multiple (0.0) | AP/AC (1.2) | 0.03 (0.00 to 6.18) | <0.001 |
| REDUCE (2017) | 664 | Gore HELEX or CARDIOFORM (0.4) | AP (1.7) | 0.23 (0.09 to 0.62) | 0.002 |
Incidence rate indicates the trial’s primary endpoint rate per 100 person-years.
AC, anticoagulant; AP, antiplatelet; PFO, patent foramen ovale; RESPECT, Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment; PC, Percutaneous Closure of Patent Foramen Ovale in Cryptogenic Embolism Trial.