title: A meta-analysis of transcatheter closure of patent foramen ovale versus medical therapy for prevention of recurrent thromboembolic events in patients with cryptogenic cerebrovascular events.
abstract: OBJECTIVE
  We sought to perform a meta-analysis of randomized controlled trials (RCTs) comparing percutaneous patent-foramen-ovale (PFO) closure with medical therapy for preventing recurrent thromboembolic events after cryptogenic stroke.
  
  
  BACKGROUND
  Observational studies suggested that transcatheter PFO closure decreases recurrent events after cryptogenic stroke; however, three recent RCTs failed to demonstrate such benefit.
  
  
  METHODS
  Trials were identified from the PubMed and Cochrane databases. Primary endpoint was the composite of transient ischemic attack (TIA) and ischemic cerebrovascular events (CVA). Both intention-to-treat (ITT) and as-treated analyses (AT) were performed.
  
  
  RESULTS
  Three RCTs met inclusion criteria. The pooled data provided 2,303 patients, of which 1,150 were in the PFO closure group and 1,153 in the medical therapy group. In the ITT analysis, there were 43 events (3.7%) of the composite end point in the closure group compared with 61 events (5.3%) in the medical therapy group, with a trend in favor of the PFO closure (OR = 0.70; 95% CI, 0.47-1.05, P = 0.08). The incidences of TIA, ischemic CVA, and bleeding were not statistically different between the groups. There was a trend for the more frequent occurrence of atrial fibrillation in the PFO closure group (OR = 3.29; 95% CI, 0.86-12.60, P = 0.08). In the AT analysis, the composite end point was significantly less frequent in the PFO closure group (OR = 0.62; 95% CI, 0.41-0.94, P = 0.02).
  
  
  CONCLUSIONS
  In this meta-analysis of contemporary RCTs, successful transcatheter closure of PFO might be more effective than medical therapy alone for the prevention of recurrent thromboembolic events.
authors.affiliation: Columbia University Division of Cardiology, Mount Sinai Heart Institute, Miami Beach, Florida.
authors.forename: Andrés M
authors.initials: AM
authors.lastname: Pineda
authors.forename: Francisco O
authors.initials: FO
authors.lastname: Nascimento
authors.forename: Solomon C
authors.initials: SC
authors.lastname: Yang
authors.forename: Ajay J
authors.initials: AJ
authors.lastname: Kirtane
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Sommer
authors.forename: Nirat
authors.initials: N
authors.lastname: Beohar
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D002561:Cerebrovascular Disorders / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D016009:Chi-Square Distribution; D054092:Foramen Ovale, Patent / Q000150:complications / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D006801:Humans; D057194:Intention to Treat Analysis; D016017:Odds Ratio; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D055502:Secondary Prevention; D013923:Thromboembolism / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors
keywords: anticoagulant agents; antiplatelet agents; meta-analysis; patent foramen ovale; septal occluder device; stroke