Background: There is an ongoing debate on the role of percutaneous closure of patent foramen ovale (PFO) in preventing recurrent ischemic events in patients with cryptogenic stroke and PFO. We systematically reviewed the latest randomized data on the efficacy and safety of percutaneous PFO closure in patients with cryptogenic stroke and PFO.
Methods: MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched in April 2013 for eligible randomized controlled trials (RCTs). Primary outcome measures included: (i) stroke; (ii) transient ischemic attack (TIA); and (iii) all-cause mortality. Secondary outcomes were new-onset atrial fibrillation (AF) and bleeding.
Results: We included a total of three RCTs randomizing 2303 participants. The intervention groups used either the STARFlex® Septal Closure System (one trial, n = 447) or the AMPLATZER™ PFO Occluder (two trials, n = 703). Control arms (n = 1153) used medical treatment composing of antiplatelet or anticoagulation therapy. There were no significant differences between groups in the analyses of stroke (odds ratio (OR) 0.65, 95% confidence interval (CI) 0.36-1.20, P = 0.17), TIA (hazard ratio (HR) 0.77, 95% CI 0.45-1.32, P = 0.35), all-cause mortality (OR 0.65, 95% CI 0.23-1.85, P=0.42) or bleeding (OR 1.43, 95% CI 0.47-4.42, P = 0.53). Percutaneous PFO closure was associated with a significantly higher incidence of new-onset AF as compared to medical therapy (OR 3.77, 95% CI 1.44-9.87, P = 0.007).
Conclusions: Currently-available randomized data do not support the use of percutaneous PFO closure for secondary stroke prevention in patients with cryptogenic stroke and PFO. An updated meta-analysis including further data from ongoing RCTs is warranted.
Keywords: Cryptogenic stroke; Meta-analysis; Patent foramen ovale; Percutaneous transcatheter closure; Transient ischemic attack.