Table 2.
Summary of PFO closure trials
| CLOSURE [37] | PC [38] | RESPECT [39] | CLOSE [10] | REDUCE [11] | DEFENSE-PFO (12) | |
|---|---|---|---|---|---|---|
| Year published | 2012 | 2013 | 2013 | 2017 | 2017 | 2018 |
| # Enrolled | 909 | 414 | 980 | 663 | 664 | 120 |
| Age (years) | ≤ 60 | < 60 | ≤ 60 | ≤ 60 | < 60 | ≤ 80 |
| Interventions | ||||||
| Device | Starflex | Amplatzer | Amplatzer | Multiple Devices | Helex or Cardioform | Amplatzer |
| Medical | AP, AC, or Both | AP or AC | AP or AC | AP or AC | AP | AP or AC |
| Mean/median follow-up | 2 years | 4.1 years | 2.6 years | 5.4 years | 3.2 years | 2.8 years |
| Results | No significant difference in the composite primary end point of stroke of TIA (w/in 2 years), all-cause death (w/in 30 days), and neurologic death (between 31 days and 2 years) (aHR: 0.78; 95% CI: 0.45–1.35; p = 0.37) | No significant difference in the composite primary end point of death, nonfatal stroke, TIA, or peripheral embolism (HR: 0.63; 95% CI: 0.24–1.62) | No significant difference in the composite primary end point of recurrent nonfatal IS, fatal IS, or early death (HR: 0.49; 95% CI: 0.22–1.11) | PFO closure associated with reduced incidence of ischemic stroke (HR: 0.03; 95% CI: 0.0–0.26) | PFO closure associated with reduced incidence of ischemic stroke (HR: 0.23; 95% CI: 0.09–0.62) | The composite primary endpoint of stroke, vascular death, or TIMI-defined major bleeding only occurred in the medication-only group (12.9% vs 0%, p = 0.013) |
| Notable adverse events | Higher incidence of AF in closure group: 5.7% vs 0.7% (p < 0.001) | Trend toward higher incidence of AF in the closure group (HR: 3.15; 95% CI: 0.64–15.6, p = 0.16) | Trend toward higher incidence of AF in the closure group (3.0% and 1.5%; p = 0.13) | Higher incidence of AF in closure group: 4.6% vs 0.9% (p < 0.02) | Higher incidence of AF in closure group: (6.6% vs. 0.4%, p < 0.001) | AF occurred in 2 patients in the medication-only group, and no patients in the closure group |
AC anticoagulation, AF atrial fibrillation, aHR adjusted hazard ratio, AP antiplatelets, CI confidence interval, CLOSE Closure of Patent Foramen Ovale or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence, CLOSURE A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of the STARFlex® Septal Closure System Versus Best Medical Therapy in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale, DEFENSE-PFO Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale Trial, PC Randomized Clinical Trial Comparing the Efficacy of Percutaneous Closure of Patent Foramen Ovale (PFO) With Medical Treatment in Patients With Cryptogenic Embolism, IS ischemic stroke, REDUCE GORE® HELEX® Septal Occluder/GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients With Patent Foramen Ovale (PFO), RESPECT Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment Trial, TIA transient ischemic attack, TIMI thrombolysis in myocardial infarction