PFO Closure vs. Medical Therapy in Stroke or TIA Patients

Study Questions:

What is the efficacy and safety of patent foramen ovale (PFO) closure versus medical treatment in patients with cryptogenic stroke or transient ischemic attack (TIA)?

Methods:

The investigators searched PubMed until September 24, 2017, for trials comparing PFO closure with medical treatment in patients with cryptogenic stroke/TIA using the items: stroke or cerebrovascular accident or TIA and PFO or paradoxical embolism and trial or study. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated for each outcome using the Mantel–Haenszel random-effects method.

Results:

Among 851 identified articles, five were eligible. In 3,627 patients with 3.7-year mean follow-up, there was a significant difference in ischemic stroke recurrence (0.53 vs. 1.1 per 100 patient-years, respectively; OR, 0.43; 95% CI, 0.21-0.90; relative risk reduction, 50.5%; absolute risk reduction, 2.11%; and number needed to treat to prevent one event, 46.5 for 3.7 years). There was no significant difference in TIAs (0.78 vs. 0.98 per 100 patient-years, respectively; OR, 0.80; 95% CI, 0.53-1.19) and all-cause mortality (0.18 vs. 0.23 per 100 patient-years, respectively; OR, 0.73; 95% CI, 0.34-1.56). New-onset atrial fibrillation occurred more frequently in the PFO closure arm (1.3 vs. 0.25 per 100 patient-years, respectively; OR, 5.15; 95% CI, 2.18-12.15) and resolved in 72% of cases within 45 days, whereas rates of myocardial infarction (0.12 vs. 0.09 per 100 patient-years, respectively; OR, 1.22; 95% CI, 0.25-5.91) and any serious adverse events (7.3 vs. 7.3 per 100 patient-years, respectively; OR, 1.07; 95% CI, 0.92-1.25) were similar.

Conclusions:

The authors concluded that in patients with cryptogenic stroke/TIA and PFO who have their PFO closed, ischemic stroke recurrence is less frequent compared with patients receiving medical treatment.

Perspective:

This updated meta-analysis of randomized controlled trials of PFO closure versus medical treatment reports that patients with cryptogenic stroke/TIA and PFO who have their PFO closed compared with patients receiving medical treatment have lower ischemic stroke recurrence, but not TIA or all-cause mortality or MI or any serious adverse event. However, new-onset atrial fibrillation was more frequent in the PFO closure group, but was mostly transient. While this present meta-analysis seems favorable for PFO closure, an individual patient data pooled analysis of all randomized trials of PFO closure would provide greater insight into the role of atrial septal aneurysm, the size of the shunt, the age of the patient, the type of antithrombotic treatment, and other potential confounders.

Clinical Topics: Arrhythmias and Clinical EP, Congenital Heart Disease and Pediatric Cardiology, Prevention, Atrial Fibrillation/Supraventricular Arrhythmias, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Quality Improvement

Keywords: Atrial Fibrillation, Embolism, Paradoxical, Foramen Ovale, Patent, Heart Defects, Congenital, Ischemic Attack, Transient, Myocardial Infarction, Primary Prevention, Recurrence, Risk, Stroke, Vascular Diseases


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