A device that reduces the risk of a second stroke in patients whose first may have resulted from a blood clot traveling through a patent foramen ovale (PFO) and on to the brain has received FDA approval.
St. Jude Medical
The Amplatzer PFO Occluder is inserted through a catheter placed in a leg vein and then implanted between the right and left atria to seal the PFO. Previous studies hadn’t shown conclusively whether closing the PFO could prevent a subsequent stroke in patients who had had a cryptogenic ischemic stroke. So investigators from 7 US clinical centers launched a trial to find a more definitive answer.
From August 2003 to December 2011, the investigators randomly assigned 980 patients with a PFO who had survived a cryptogenic ischemic stroke to receive the device and blood-thinning medication or medication alone. In the medication group, 17.2% of patients dropped out compared with 9.2% of patients in device group. The gap created a significant difference in follow-up time: 1375 years in the device group vs 1184 years in the medication group.
During the study period, 9 of 499 patients in the device group and 16 of 481 patients in the medication group had a nonfatal ischemic stroke—a 51% reduction in recurrent strokes among patients who received the device and medication compared with medication alone. The reduction wasn’t statistically significant, but the investigators said treatment with the device and medication was clinically superior to medication alone.
“[P]atients need to be evaluated carefully by a neurologist and cardiologist to rule out other known causes of stroke and help ensure that PFO closure with the device is likely to assist in reducing the risk of a recurrent stroke,” Bram Zuckerman, MD, of the FDA’s Center for Devices and Radiological Health, said in a statement.
read more at JAMA