PFO Occluder Device May Be Superior to Medical Management

RESPECT Versus CLOSURE Trials
Dr. Saver suggested several possible reasons that PFO closure with a device was associated with a likely benefit in the RESPECT trial, although the procedure did not demonstrate a benefit in the previous CLOSURE trial. "We followed patients up to eight years, and CLOSURE only followed patients for two years. If you look at the Kaplan–Meier curves that we have up to two years, they look very similar to the Kaplan–Meier curves for CLOSURE, which were going in the right direction, but they did not reach statistical significance," said Dr. Saver.

The RESPECT trial included more stringent criteria for patient selection than CLOSURE, and may also have tested a better device, noted Dr. Saver. The AMPLATZER PFO Occluder was not associated with a significant increase in atrial fibrillation in patients who received it. It thus did not create risk factors for stroke as other devices have, he added.

"Consideration of the neurovascular aspects of the RESPECT trial reinforces the primary analysis," said Dr. Saver. "Stringent patient selection to identify patients with a history of cryptogenic stroke and PFO closure with the AMPLATZER PFO Occluder showed evidence of benefit over medical management alone," he concluded.