An Updated Meta-Analysis Comparing Percutaneous Device Closure with Medical Therapy Alone for Patent Foramen Ovale in Patients with Cryptogenic Stroke
Background
Epidemiologic studies suggest that PFO is associated with cryptogenic stroke. Early 3 RCTS failed to prove the superiority of PFO closure over medical therapy alone (MTA). Last year new trials and meta-analyses proved superiority of PFO closure over MTA, however, a new positive RCT (DEFENCE-PFO) has been reported, making previous meta-analyses arguably out of date .
Methods
Scientific databases were searched for relevant RCTs. Pooled risk ratios were calculated using a random-effects model.
Results
Data from 6 RCTs enrolling 3747 patients were included. Compared to MTA, PFO closure decreased recurrent stroke risk by 59% (Figure A). Risk for major bleeding was similar between the two therapies. However, moderate heterogeneity (I2 = 57.5%) was found for the risk of major bleeding. Sensitivity analysis suggests the heterogeneity was derived from the CLOSURE I trial; once it was removed, heterogeneity resolved, and device therapy was associated with a statistically significant decrease in risk of major bleeding (Figure D). Device closure was also associated three-fold increased risk of atrial fibrillation (AF).
Conclusions
In this updated meta-analysis of six RCTs involving the largest sample size to date, we found that in patients with cryptogenic stroke, device closure for PFO decreases recurrent risk of stroke and increases incidence of AF compared to MTA. In addition, with the larger sample size, we were able to show that use of new-generation devices was also associated with lower risk of major bleeding compared to MTA; this potential benefit of device closure has not been reported in any previously meta-analysis (probably due to type II error). 