Strokes of unknown origin cryptogenic strokes have several causes, including PFO, a hole that is vital to fetal survival between the heart's two upper chambers if it doesn't close completely after birth. If a blood clot arises in a vein and passes through the hole and reaches the brain (called "paradoxical embolism"), a stroke results. In roughly 20 percent of adults, remnants of the hole persist.
CLOSURE I is the first completed prospective, randomized, two-arm superiority trial of percutaneous PFO device closure versus medical therapy alone in cryptogenic stroke patients using the STARFlex Septal Closure System. The device, attached to a catheter and threaded into the upper heart, applies a "clamshell" patch on both sides of the hole.
The trial's primary endpoint was the difference in the stroke and TIA rates between the two patient groups at two years, death from all causes in the first 30 days, and death from neurological causes at 30 days or more.
Dr. Furlan and colleagues enrolled 909 patients at 87 United States and Canadian sites during 64 months ending October 2008. Researchers randomized patients to either medical therapy (325 mg of aspirin or the appropriate warfarin dose, or a combination of both) or PFO closure and medical therapy (75 mg of clopidogrel for six months and 325 mg of aspirin for two years).
"Based on the trial results, even though a patient had a PFO and a recurrent stroke, the hole may be totally coincidental to the second stroke," Dr. Furlan said. "The undeniable message here is that too many of these holes are being closed with an off-label procedure, but partly that is because we've never had a randomized trial to gu
|Contact: George Stamatis|
University Hospitals Case Medical Center