Results of the PC trial presented at TCT 2012

Clinical trial shows that PFO closure with investigational device does not decrease ischemic and bleeding events compared to medical therapy

2012-10-25

(Press-News.org) MIAMI, FL – OCTOBER 25, 2012 – A clinical trial that compared catheter-based PFO closure using an investigational device found that there was no significant reduction in ischemic and bleeding events compared to standard medical therapy; stroke risk was non-significantly reduced with device therapy. The PC Trial was presented at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.

A PFO (patent foramen ovale) is a hole between the left and right upper chambers (atria) of the heart that fails to close just after birth. Approximately one in four people grow up with a PFO. In some cases a blood clot may pass through the PFO and can potentially travel to the brain causing an ischemic stroke. It is estimated that PFO rates are three times higher in the population of patients with cryptogenic stroke, or stroke without an overt source.

The PC Trial compared the efficacy of the percutaneous closure of a PFO using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic stroke with peripheral embolism. Made of wire mesh, the investigational device is inserted into the PFO through a catheter to seal the passageway between the left and right atria.

Patients were randomized in 29 centers in Europe, Brazil, Canada, and Australia. Enrollment of 414 patients was completed in February 2009. The primary endpoint of the trial was a composite of death from any cause, non-fatal stroke, transient ischemic attack (TIA), and peripheral embolism.

For the primary composite endpoint (death from any cause, non-fatal stroke, TIA, and peripheral embolism) researchers found a relative risk reduction of 37 percent when using the investigational device; this reduction was not statistically significant. Results also indicated no significant reduction in ischemic and bleeding events in patients who underwent PFO closure compared to those who received medical therapy (2.9 percent versus 5.7 percent, HR 0.49, 95 percent CI 0.19 – 1.32, P=0.16). The relative risk reduction of stroke through use of the device was 80 percent with a number needed to treat (NNN) of 40, but this reduction was also not statistically significant.

"Percutaneous PFO closure with the investigational Amplatzer PFO Occluder device for secondary prevention of thromboembolism showed no significant reduction in ischemic and bleeding events compared with medical treatment in this trial," said study investigator Stephan Windecker, MD. Dr. Windecker is a Professor and Head of Interventional Cardiology at the Swiss Cardiovascular Center in Bern.

"However, the observed difference in stroke may be clinically relevant if confirmed in further studies," Dr. Windecker said.

###The results of The PC Trial will be presented on Thursday October 25 at 11:27 AM EST in the Main Arena (Hall D) of the Miami Beach Convention Center.

The trial was funded in part by an unrestricted grant provided by St. Jude Medical, Inc. Dr. Windecker reported grant support from St. Jude Medical related to research in the field of optical coherence tomography.

About CRF The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education. Since its inception in 1991, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies and therapies in interventional cardiovascular medicine.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of the Cardiovascular Research Foundation. TCT gathers leading medical researchers and clinicians from around the world to present and discuss the latest developments in the field.

For more information, visit www.crf.org.

ELSE PRESS RELEASES FROM THIS DATE:

University of Toronto study demonstrates impact of adversity on early life development

2012-10-25

TORONTO, ON – It is time to put the nature versus nurture debate to rest and embrace growing evidence that it is the interaction between biology and environment in early life that influences human development, according to a series of studies recently published in a special edition of the Proceedings of the National Academy of Sciences (PNAS). "Biologists used to think that our differences are pre-programmed in our genes, while psychologists argued that babies are born with a blank slate and their experience writes on it to shape them into the adults they become. Instead, ...

For the Milky Way, it's snack time

2012-10-25

Using the Sloan Digital Sky Survey, researchers have discovered a band, or stream, of stars believed to be the remnant of an ancient star cluster slowly being ingested by the Milky Way, Earth's home galaxy. "The Milky Way is constantly gobbling up small galaxies and star clusters," said Ana Bonaca, a Yale graduate student and lead author of a study forthcoming in Astrophysical Journal Letters. "The more powerful gravity of our Milky Way pulls these objects apart and their stars then become part of the Milky Way itself." Researchers have previously found evidence of ...

Far from random, evolution follows a predictable genetic pattern, Princeton researchers find

2012-10-25

Evolution, often perceived as a series of random changes, might in fact be driven by a simple and repeated genetic solution to an environmental pressure that a broad range of specieshappen to share, according to new research. Princeton University research published in the journal Science suggests that knowledge of a species' genes — and how certain external conditions affect the proteins encoded by those genes — could be used to determine a predictable evolutionary pattern driven by outside factors. Scientists could then pinpoint how the diversity of adaptations seen ...

Size does matter in sexual selection, at least among beetles

2012-10-25

A new collaborative project among researchers from Uppsala University in Sweden and the University of Cincinnati has, for the first time, demonstrated experimentally the evolutionary force behind the rapid evolution of male genitals, focusing on a species of seed beetle. This mechanism is revealed in a study published today in the scientific journal Current Biology. The experiments leading to this paper involved a species of seed beetle known as Callosobruchus maculatus. Mating among these beetles involves several males engaging in copulation with individual females. ...

Results of the POSEIDON trial presented at TCT 2012

2012-10-25

MIAMI, FL – OCTOBER 25, 2012 – A hydration regimen tailored to the patient's fluid status was effective in reducing damage to kidneys in patients undergoing cardiac catheterization, according to a study presented at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. Contrast-induced acute kidney injury (CI-AKI), or contrast-induced nephropathy, refers to kidney damage that may occur ...

1-year results of ADAPT-DES presented at TCT 2012

2012-10-25

MIAMI, FL – OCTOBER 25, 2012 – Patients who receive a drug-eluting stent (DES) and demonstrate low levels of platelet inhibition are more likely to have blood clots form on the stent and suffer a possible heart attack; conversely, patients with higher levels of platelet inhibition are at greater risk for bleeding complications. One-year results of the ADAPT-DES study were presented today at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation, TCT is the world's premier educational meeting ...

Safety glass - cut to any shape

2012-10-25

If an object slams into the glass façade of a high-rise building, the glass must not shatter and fall down, because it could harm pedestrians below. In addition, the window panes must hold if a person were to fall against it from the inside. Architects and builders therefore must use something stronger than laminated safety glass on the façades of high rise buildings. The same applies to the windshields on cars. Safety glass prevents passengers in an accident from getting hurt by glass shards. And shop windows made of safety glass are expected to reliably safeguard the ...

"Spoon River Revisited" by Daniel J. Benor, MD: Messages From the Spirits - Halloween Launch From Wholistic Healing Publications

2012-10-25

One man's death is a tragedy; a million is a statistic. - Joseph Stalin This book of prose poems is a captivating visit to the legendary town of Spoon River, viewed through the epitaphs of its residents. SPOON RIVER REVISITED is an insightful sequel to Edgar Lee Master's 1916 classic, Spoon River Anthology. The people who share their modern stories still struggle with challenges of growing up, making their way through life, and passing on. Death has an undeserved, bad reputation! Within the understandings of western medicine, when the body stops working, that is ...

Timing is everything: Hormone use may reduce or increase Alzheimer's disease risk in women

2012-10-25

MINNEAPOLIS – A new study suggests that women who begin taking hormone therapy within five years of menopause may reduce their risk of developing Alzheimer's disease. The research is published in the October 24, 2012, online issue of Neurology®, the medical journal of the American Academy of Neurology. "This has been an area of debate because observational studies have shown a reduced risk of Alzheimer's disease with hormone therapy use, while a randomized controlled trial showed an increased risk. Our results suggest that there may be a critical window near menopause ...

Nearly 80 million Americans won't need vitamin D supplements under new guidelines

2012-10-25

MAYWOOD, Ill. - Nearly 80 million Americans would no longer need to take vitamin D supplements under new Institute of Medicine guidelines, according to a study by Loyola University Chicago Stritch School of Medicine researchers. Results were published Oct. 24, 2012 in the journal PLOS ONE. The new guidelines advise that almost all people get sufficient vitamin D when their blood levels are at or above 20 nanograms per milliliter (ng/ml). Older guidelines said people needed vitamin D levels above 30 ng/ml. Holly Kramer, MD, MPH and colleagues examined data from 15,099 ...

Results of the PC trial presented at TCT 2012

ELSE PRESS RELEASES FROM THIS DATE:

LAST 30 PRESS RELEASES: