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CLOSURE I: Percutaneous PFO Closure Did Not Improve Outcomes vs. Medical Therapy
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Confirming what was presented at the American Heart Association Scientific Sessions in 2010, The New England Journal of Medicine has published the findings from the CLOSURE I trial indicating that a percutaneous device for the treatment of patent foramen ovale did not reduce rates of stroke or transient ischemic attack compared with medical therapy alone.
For the multicenter, randomized, open-label trial, investigators enrolled 909 patients presenting with a cryptogenic stroke or TIA who had a PFO. Patients were either treated with a PFO closure device (STARFlex, NMT Medical; n=447) or medical therapy (n=462).
The primary endpoint of a composite of stroke or TIA during the 2-year follow-up was observed in 5.5% of patients in the closure group vs. 6.8% in the medical therapy group (P=.37). Individually, rates of stroke did not significantly differ in the PFO arm (2.9% vs. 3.1%; P=.79), nor did the rates of TIA (3.1% vs. 4.1%; P=.44). In both groups, no deaths were reported at 30 days and no deaths from neurologic causes occurred during the 2 years.
For more information:
Furlan AJ. N Engl J Med. 2012;366:991-999.
Perspective
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Marco A. Costa, MD, PhD
I don’t think the results of CLOSURE I are surprising if you were part of the trial. It was very hard to enroll patients, because many who really needed the procedure were not taking the chance to get into the trial. So most of the time patients who were young and most likely had the typical cryptogenic stroke related to the PFO were not included in the trial and went for the off-label therapy because they didn’t want to take the risks or have to take warfarin (Coumadin, Bristol-Myers Squibb) for life.
There was one case I remember very well. A patient who was very young and a martial arts expert came to us with a recent cryptogenic stroke. But when I proposed that he participate in the study, he decided to go somewhere else and got his PFO closure in a private hospital where there was no question of participating in the trial.
So, overall, the trial investigators were very responsible and tried to enroll the proper patients, and the design and conduct of the trial were appropriate; but the proper patients did not want to get into this trial.
In terms of the future of percutaneous PFO closure, I believe that will depend a lot on the outcomes of the RESPECT trial, which will test a different PFO occluder (Amplatzer, AGA Medical). Some data should be available by the end of the year. This might wind up being a superior device, so if the outcomes with the CLOSURE I device were not positive because of certain aspects of device design, the RESPECT trial may provide better data.
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