PFO closure device no better than drugs alone in preventing recurrent strokes or TIAs

Loyola was major enroller in landmark clinical trial

Loyola University Medical Center is one of the major enrollers in a landmark clinical trial that found that plugging a hole in the heart works no better than drugs in preventing strokes.

The study is published in the New England Journal of Medicine. Loyola enrolled 24 patients, one of the highest patient enrolments in the multicenter trial, and more than any other Chicago-area hospital. Principal investigators at the Loyola site are stroke specialist Dr. Michael Schneck and interventional cardiologist Dr. Fred Leya.

About 1 in 4 adults has a small hole in the wall that separates the top two chambers of the heart. It's called a patent foramen ovale (PFO). For most people, a PFO poses no problems. But in some cases, a clot can pass through the hole, migrate to the brain and trigger a stroke.

The standard treatment is medication to prevent blood clots, typically aspirin or Coumadin. A newer treatment is to plug the hole with a device delivered by a catheter. The catheter is inserted into a blood vessel at the top of the leg and guided up to the heart. When the catheter reaches the PFO, the device is deployed, opening like an umbrella to plug the hole.

The clinical trial included 909 patients who had PFOs, and had previously suffered strokes or mini strokes called transient ischemic attacks (TIAs). They were randomly assigned to receive a PFO closure device plus blood thinners or drug therapy alone.

The closure device worked no better than drugs alone in preventing recurrent strokes or TIAs. Moreover, major vascular complications occurred in 3.2 percent of the closure group.

"Medical therapy is just as good as the device," Schneck said. "The larger lesson is that we have an impetus in the United States for doing procedures without first standing back and asking all the right questions."

Leya noted the clinical trial used an older version of a closure device. "I would like to see more research to determine if better devices will have better results," he said.