Device closure of patent foramen ovale versus medical therapy in cryptogenic stroke: A systematic review and meta-analysis

Abstract

Objectives This study sought to perform a meta-analysis of randomized controlled trials comparing device closure with medical therapy in the prevention of recurrent neurological events in patients with cryptogenic stroke and patent foramen ovale. Background The optimal strategy for secondary prevention of cryptogenic stroke with a patent foramen ovale is unclear. Methods Several databases were searched from their inception to March 2013, which yielded 3 eligible studies. The results were pooled as per the different patient populations defined in the studies: - intention-to-treat, per-protocol, and as-treated cohorts. A generic inverse method was used based on time-to-event outcomes in a fixed-effect model. A supplementary analysis pooled the results from only 2 trials (RESPECT [Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment] and PC Trial [Randomized Clinical Trial Comparing the Efficacy of Percutaneous Closure of Patent Foramen Ovale (PFO) With Medical Treatment in Patients With Cryptogenic Embolism]) as a similar device was used in them. Results Our meta-analysis yielded effect-estimate hazard ratios of 0.67 (95% confidence interval [CI]: 0.44 to 1.00, I2 = 0%) in the intention-to-treat cohort, 0.62 (95% CI: 0.40 to 0.95). I2 = 0%) in the per-protocol cohort, and 0.61 (95% CI: 0.40 to 0.95, I2 = 38%) in the as-treated cohort, showing beneficial effects of device closure. The results became more robust with pooled results from RESPECT and the PC Trial: The effect-estimate hazard ratios being 0.54 (95% CI: 0.29 to 1.01, I2 = 0%), 0.48 (95% CI: 0.24 to 0.94, I2 = 26%), and 0.42 (95% CI: 0.21 to 0.84, I2 = 26%) in the intention-to-treat, per-protocol, and as-treated populations, respectively. Conclusions Our meta-analysis suggests that PFO closure is beneficial as compared to medical therapy in the prevention of recurrent neurological events. This meta-analysis helps to further strengthen the role of device closure in cryptogenic stroke. © 2013 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER INC.