Controversial PFO Closure Trials Published In NEJM

Amplatzer

Two controversial trials testing PFO closure with the Amplatzer PFO Occluder (St. Jude Medical) in patients with cryptogenic stroke, first presented last fall at the TCT meeting, have now been published in the New England Journal of Medicine. Both trials missed their primary endpoints but contained suggestions of possible benefit. The results appear unlikely to resolve…

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Research And Denial At St Jude Medical

Research and development is the cornerstone of medical progress, but sometimes R&D turns into its evil twin brother, research and denial. Yesterday I reported on the the RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment) trial presented at the TCT meeting in Miami. The trial missed its primary…

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TCT: Two PFO Closure Trials Miss Primary Endpoints

Two trials presented today at the TCT meeting in Miami testing the benefits of PFO closure in patients with cryptogenic stroke have failed to convincingly demonstrate any significant  benefit for the controversial procedure. The RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment) trial randomized 980 patients  to PFO closure…

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