Device Closure of Patent Foramen Ovale After Stroke
Pooled Analysis of Completed Randomized Trials
David M. Kent, Issa J. Dahabreh, Robin Ruthazer, Anthony J. Furlan, Mark Reisman, John D. Carroll, Jeffrey L. Saver, Richard W. Smalling, Peter Jüni, Heinrich P. Mattle, Bernhard Meier and David E. Thaler
Patent Foramen Ovale Closure in Stroke Trials: Kaplan-Meier Curves Comparing Device Closure Versus Medical Therapy
Kaplan-Meier curves comparing device closure (orange) versus medical therapy (blue). Results shown for all trials pooled (A, B) and for occluder device trials only (RESPECT [Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (2)] and PC Trial [Percutaneous Closure of Patent Foramen Ovale in Cryptogenic Embolism (3)]) (C, D), and for both the primary composite and ischemic stroke outcomes. Secondary composite outcome (including only early death) was statistically significant for both the 3-trial (log-rank p = 0.0488) and the disc occluder-only analysis (log-rank p = 0.0451). TIA = transient ischemic attack.