Conflict of interest: Nothing to report.
Pediatric and Congenital Heart Disease
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
Article first published online: 5 AUG 2013
Copyright © 2013 Wiley Periodicals, Inc.
Catheterization and Cardiovascular Interventions
Volume 82, Issue 6, pages 968–975, 15 November 2013
How to Cite
Pineda, A. M., Nascimento, F. O., Yang, S. C., Kirtane, A. J., Sommer, R. J. and Beohar, N. (2013), 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. Cathet. Cardiovasc. Intervent., 82: 968–975. doi: 10.1002/ccd.25122
- Issue published online: 6 NOV 2013
- Article first published online: 5 AUG 2013
- Accepted manuscript online: 5 JUL 2013 09:31AM EST
- Manuscript Accepted: 30 JUN 2013
- patent foramen ovale;
- septal occluder device;
- antiplatelet agents;
- anticoagulant agents;
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.
Observational studies suggested that transcatheter PFO closure decreases recurrent events after cryptogenic stroke; however, three recent RCTs failed to demonstrate such benefit.
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.
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).
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. © 2013 Wiley Periodicals, Inc.