http://www.theheart.org/article/1369823.do?utm_campaign=newsletter&utm_medium=email&utm_source=20120315_EN_Heartwire_R01
A device that many hoped might change the landscape of stroke prevention will likely never get the chance to prove itself properly for a host of reasons now being lamented by experts, as the first randomized clinical trial in this arena finally makes its way to print [1]. Published online today in the New England Journal of Medicine, the CLOSURE I trial of patent foramen ovale (PFO) closure for stroke/transient ischemic attack (TIA) showed no differences in outcomes between the device and medical therapy. Despite its much-discussed flaws, the trial is in the minds of many the best available evidence to date and should lead to a slowdown in the use of PFO-closure devices.
As previously reported by heartwire, principal investigator for the trial, Dr Anthony Furlan (Case Western Reserve University, Cleveland, OH), first presented the results in November 2010 at the American Heart Association Scientific Sessions.
Speaking with heartwire, Furlan recounted the hurdles the trialists faced in getting to the finish line, in particular the excruciatingly slow enrollment, hampered by rampant off-label use of the devices in patients whose physicians felt could not run the risk of being randomized to medical management.
"No randomized trial is perfect," Furlan said. "We move our understanding of the problem forward incrementally. There is a reason nobody ever did a randomized trial previously. . . . It took us nine years to get this into print, and that doesn't even include the year it took to design the trial. So 10 years of stick-to-it-ness to get to this discussion."
The rest at the link.
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