–A sham-controlled trial defies previous expectations. A rigorous sham-controlled trial has failed to demonstrate a significant benefit for patent foramen ovale (PFO) closure in addressing frequent migraine headaches. There has long been a strong suspicion that some migraine headaches may be caused by PFO, but this relationship has never been conclusively demonstrated, and it has…
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…
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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