–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…
Interventional Cardiology And The Rejection Of Science
July 22, 2016 by 6 Comments
–Prominent interventional cardiologist says clinical trials are slowing progress In their eagerness to embrace a glorious future of ever more spectacular technology-based advances, interventional cardiology— a subspecialty never exactly known for caution, patience, or self reflection— is poised to reject science, evidence-based medicine, and randomized controlled trials. “Generating and publishing evidence is a tedious job,”…
Research And Denial At St Jude Medical
October 26, 2012 by 2 Comments
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
October 25, 2012 by 1 Comment
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…
St Jude CEO Spills The Beans On PFO Closure Trial
July 23, 2012 by 1 Comment
(Updated at bottom with statement from St. Jude Medical) Dan Starks, the CEO of St Jude Medical, stated during a quarterly earnings call last week that results of the RESPECT trial of PFO closure for crytpogenic stroke were “favorable” and that the full trial results will be presented in October at the TCT meeting in Miami. But his statement…
Achieving CLOSURE: Final Act of PFO Closure Device
March 14, 2012 by Leave a Comment
You can choose from a myriad of metaphors– closing the book, sealing the deal, fixing a hole– but the story is simple: the publication of CLOSURE 1 in the New England Journal of Medicine is the final act of the long and sad melodrama of the CLOSURE 1 trial. As initially reported at the American Heart Association…
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