A clinical trial indicates that using an investigational medical device to close a PFO, or "hole in the heart," may be superior to medical management alone in the prevention of a repeated stroke. Results of the RESPECT trial were presented today at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.
A PFO (patent foramen ovale) is a flap-like opening between the left and right upper chambers (atria) of the heart, which typically fuses shut after birth. In approximately one in four people, the opening does not fuse shut and in some cases, a blood clot may pass through the PFO and potentially travel to the brain causing an ischemic stroke. It is estimated that PFO rates are three times higher in the patient population with cryptogenic stroke, or stroke without an overt source. However, to date, no randomized clinical trial has demonstrated superiority of PFO closure over standard medical therapy for secondary stroke prevention, despite there being observational data suggesting a possible benefit.
RESPECT was a prospective, randomized (1:1), multi-center trial designed to evaluate whether PFO closure with the AMPLATZER PFO Occluder is superior to the current standard medical treatment in the prevention of recurrent stroke (a second stroke). Made of wire mesh, the investigational device is inserted into the PFO through a catheter to seal the passageway between the left and right atria.
A total of 980 patients were enrolled over eight years. Patients diagnosed with a cryptogenic stroke and PFO (age 18-60) were randomized to either the investigational device group or the medical therapy group within 270 days of the stroke. Forty-nine percent of the patients had a large stroke as the qualifying stroke event. The average age in the study was 46 and patients were otherwise generally healthy.
Statistics from the RESPECT trial: