Study shows PFO closure may be superior to medical therapy in preventing stroke

October 25, 2012, University of Texas Health Science Center at Houston

Results of a large-scale, randomized clinical trial called RESPECT revealed that patent foramen ovale (PFO) closure may be superior to medical therapy in preventing recurrent stroke, according to a presentation of findings today at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Miami.

"In contrast to a previously reported randomized trial for the treatment of cryptogenic , the RESPECT trial enrolled only patients with documented cryptogenic embolic strokes and excluded patients with other potential causes of stroke and/or TIA. The period of follow-up approached nine years and was not restricted to only events within the initial two years of follow-up," said Richard Smalling, M.D., Ph.D., James D. Wood Distinguished Chair in Cardiovascular Medicine at The University of Texas Health Science Center at Houston (UTHealth), who served on the steering committee and as a principal investigator of the trial.

"As a result, the trial enrolled patients at high-risk for recurrent events and followed them for a long period of time, enabling the detection of relatively infrequent recurrent stroke," said Smalling, who is director of interventional at the Memorial Hermann Heart and Vascular Institute. "The totality of evidence in the RESPECT trial clearly demonstrates the superiority of device closure using the Amplatzer PFO Occluder in patients with the above entry criteria compared to standard ."

According to the National Institutes of Health, a PFO is a hole between the left and right atria (upper chambers) of the heart that fails to close naturally soon after a baby is born. In about one in four people, the hole never closes. The condition is usually not treated unless there are other or the person has a stroke caused by a blood clot. PFO has been a suspected cause of cryptogenic stroke, meaning a stroke without any identifiable cause usually occurring in people under the age of 55.

The trial enrolled 980 patients from 69 sites over eight years, yielding 2,300 patient-years of data. Medical group regimens were antiplatelet medications or warfarin. All primary endpoint events were recurrent ischemic strokes. As treated, five of the patients in the closure group had a stroke compared to 16 in the medically treated group.

"These patients with cryptogenic stroke are typically young and in the height of the productive period of their lives. Preventing a recurrent, potentially devastating, stroke by implanting a small device with very little risk is a huge potential benefit," Smalling said.

Explore further: Study finds expensive procedure no more effective than medical therapy to prevent strokes

Related Stories

Study finds expensive procedure no more effective than medical therapy to prevent strokes

March 14, 2012
A catheter procedure that closes a hole in patients' hearts was no more effective than medical therapy in preventing recurrent strokes, according to a new study published in the March 15 issue of the New England Journal of ...

TARDIS trial seeks new dimension in stroke treatment

October 17, 2011
People who suffer from acute stroke or Transient Ischaemic Attack (TIA, a mini stroke) could get better treatment in the future thanks to the expansion of a large clinical trial of a new combination of drugs led by researchers ...

Bone marrow stem cell therapy safe for acute stroke: report

August 31, 2011
Using a patient's own bone marrow stem cells to treat acute stroke is feasible and safe, according to the results of a ground-breaking Phase I trial at The University of Texas Health Science Center at Houston (UTHealth).

Recommended for you

A nanoparticle inhalant for treating heart disease

January 18, 2018
A team of researchers from Italy and Germany has developed a nanoparticle inhalant for treating people suffering from heart disease. In their paper published in the journal Science Translational Medicine, the group describes ...

Starting periods before age of 12 linked to heightened risk of heart disease and stroke

January 15, 2018
Starting periods early—before the age of 12—is linked to a heightened risk of heart disease and stroke in later life, suggests an analysis of data from the UK Biobank study, published online in the journal Heart.

'Decorated' stem cells could offer targeted heart repair

January 10, 2018
Although cardiac stem cell therapy is a promising treatment for heart attack patients, directing the cells to the site of an injury - and getting them to stay there - remains challenging. In a new pilot study using an animal ...

Two simple tests could help to pinpoint cause of stroke

January 10, 2018
Detecting the cause of the deadliest form of stroke could be improved by a simple blood test added alongside a routine brain scan, research suggests.

Exercise is good for the heart, high blood pressure is bad—researchers find out why

January 10, 2018
When the heart is put under stress during exercise, it is considered healthy. Yet stress due to high blood pressure is bad for the heart. Why? And is this always the case? Researchers of the German Centre for Cardiovascular ...

Heart-muscle patches made with human cells improve heart attack recovery

January 10, 2018
Large, human cardiac-muscle patches created in the lab have been tested, for the first time, on large animals in a heart attack model. This clinically relevant approach showed that the patches significantly improved recovery ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.