Plugging a hole in the heart doesn’t work any better than drugs in preventing strokes, a landmark clinical trial has discovered.
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,” said Dr Michael Schneck, one of the principal investigators at the Loyola University Medical Center site of the study.
“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,” he said.
The other principal investigator at Loyola, interventional cardiologist Dr Fred 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.
The study was published in the New England Journal of Medicine.
—-Agencies