Abstract 10989: 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
Introduction: Although previous observational studies have suggested that transcatheter closure of patent foramen ovale (PFO) decreases the incidence of recurrent neurological events after cryptogenic stroke, three recent randomized trials have failed to demonstrate such benefit.
Hypothesis: Percutaneous PFO closure may be better that medical therapy for preventing recurrent thromboembolic events after cryptogenic stroke when data from randomized trials is pooled in a meta-analysis.
Methods: Trials were identified from the PubMed and Cochrane databases. Assessed endpoints included: the composite of transient ischemic attack (TIA) and ischemic cerebrovascular accident (CVA), their individual incidence, and other key adverse events. Both intention-to-treat (ITT) and as-treated analyses (AT) were performed.
Results: Three randomized controlled trials met inclusion criteria and were included in the analysis. The pooled data provided a total of 2303 patients, of which 1150 were in the PFO closure group (CD) and 1153 were in the medical therapy (MM) group. In the ITT analysis, there were 43 events (3.7%) of the composite of TIA and ischemic CVA 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. Figure A). The incidences of TIA (Figure B), ischemic CVA (Figure C), and bleeding (Figure D) 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. Figure E). 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. Figure F).
Conclusion: In this meta-analysis of contemporary randomized control trials, successful transcatheter closure of PFO might be more effective than medical therapy alone for the prevention of recurrent thromboembolic events.
- © 2013 by American Heart Association, Inc.