AHA: Off-label PFO closure for stroke, TIA prevention needs to stop

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STARFlex septal closure system
Image source: J Am Coll Cardiol 2006;48:538-544

CHICAGO—Percutaneous closure with STARFlex septal renal implant plus medical therapy does not offer any significant benefit over medical therapy alone for the prevention of recurrent stroke or transient ischemic attack (TIA) in patients aged 60 or below who present with cryptogenic stroke or TIA and a patent foramen ovale (PFO), based on the results of the late-breaking CLOSURE I trial presented today at the American Heart Association (AHA) Scientific Sessions.

While no medical device is approved by the FDA for sealing PFOs, physicians use devices approved for closing other types of heart holes to seal the opening between the right and left atria, in hopes of preventing a stroke, wrote the study authors.

The prospective, multi-center, randomized, open-label, two-arm superiority CLOSURE I trial was designed to test whether PFO closure using STARFlex plus medical therapy is superior to medical therapy alone for preventing recurrent stroke or TIA in patients with cryptogenic TIA or stroke and a PFO. The medical therapy arm received 325 mg of aspirin or warfarin, or a combination of both.

The trial enrolled 447 patients in the STARFlex arm and 462 patients in the medical therapy arm at 87 sites in the U.S. and Canada.

“The study population was a relatively young stroke population, with the average age in both arms of 46 years,” explained principal investigator Anthony J. Furlan, MD, chairman of the neurology department at Case Western Reserve University School of Medicine in Cleveland, during this morning’s press conference. “The patient characteristics are fairly representative of a younger cryptogenic stroke population.”

The primary endpoint was the two-year incidence of stroke or TIA, all-cause mortality for the first 30 days and neurological mortality from 31 days to two years. Follow-up occurred at one month, six months, 12 months and 24 months, and repeat TEE at six months for all patients, and 12 and 24 months if there was residual leak.

The researchers found that percutaneous closure with STARFlex plus medical therapy did not offer any significant benefit over medical therapy alone. Also, there was no significant benefit related to degree of initial shunt, no significant benefit with atrial septal aneurysm, and an insignificant trend (1.8 percent) favoring the device driven by TIA.

Also, the researchers reported that there was a 3 percent rate of major vascular complications in the device arm, and a significantly higher rate of atrial fibrillation in the device arm (5.7 percent).

Importantly, the two-year stroke rate was essentially the same in both arms (3 percent).

“It is possible the procedure has a slight benefit, but you would need thousands of patients to find it in a randomized trial,” Furlan said. “Even though a patient has a PFO and a recurrent stroke, the hole may be totally coincidental to the second stroke.”

He concluded that the “undeniable message is that too many of these holes are being closed with an off-label procedure, but that’s partly because we’ve never had a randomized trial to guide us."

The study’s discussant concurred. Pierre Amarenco, MD, from Denis Diderot University and Bichat Hospital in Paris, said, “There is no need for PFO closure in this patient population because it is not effective and may be associated with major vascular complications, atrial fibrillation and major bleeding.”

Amarenco added that these results “should now be translated in practice for the millions of patients with stroke of unknown cases and PFO.”