Navigation Links
Results of the PC trial presented at TCT 2012
Date:10/25/2012

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.


'/>"/>
Contact: Judy Romero
jromero@crf.org
Cardiovascular Research Foundation
Source:Eurekalert

Related medicine news :

1. Results of the POSEIDON trial presented at TCT 2012
2. 1-year results of ADAPT-DES presented at TCT 2012
3. Comparison of Obesity Surgeries Turns Up Surprising Results
4. Results from study of Mead Johnsons Enfamil® Human Milk Fortifier Acidified Liquid published in Pediatrics
5. Missed Diagnoses in ICU Often Have Deadly Results: Review
6. Anti-clotting drugs yield similar results
7. Late-Night Cramming May Hurt School Test Results
8. New survey: Women want to SEE breast reconstruction results before cancer surgery
9. Weight-loss surgery results in positive changes in social life, medical conditions
10. Many Test Results Left Unread as Patients Leave Hospital: Study
11. 7-Day Stuttering Therapy May Get Results, Study Says
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/28/2017)... ... June 28, 2017 , ... Anyone with a remote control has seen the never-ending twists on ... the flipper will get rich in no time. But what about the buyers of ... for the buyer of a flipped house. An email recently sent to Gary Case ...
(Date:6/28/2017)... , ... June 28, 2017 , ... David B. Sosin, a founding partner ... took over the post of 2nd Vice President for the Illinois State Bar Association ... as the ISBA’s 3rd Vice President in 2016 following a state-wide election and served in ...
(Date:6/28/2017)... ... June 28, 2017 , ... American Farmer proudly announces ... of the award winning television series, scheduled to broadcast fourth quarter 2017. American Farmer ... as a regional supplier of garden pea seed. As demand grew, the small company ...
(Date:6/28/2017)... (PRWEB) , ... June 28, 2017 , ... ... ZEON) is pleased to announce that a two year study conducted by the ... Bromley Creek zeolite was successful in remediating potash brine-impacted groundwater. As a part ...
(Date:6/28/2017)... ... June 28, 2017 , ... Doner Financial, a Cincinnati ... to insurance assistance and financial planning services, is announcing the commencement of a ... the region facing financial crisis. , Matthew 25: Ministries (M25M) is an international ...
Breaking Medicine News(10 mins):
(Date:6/11/2017)...  Eli Lilly and Company (NYSE: LLY ) ... of galcanezumab, an investigational treatment for the prevention of ... key secondary endpoints for galcanezumab compared to placebo at ... EVOLVE-2 and REGAIN) will be presented today at the ... Boston . "The detailed ...
(Date:6/8/2017)... Fla. , June 8, 2017  Less than ... that hit more than 200,000 companies, including hospital networks, ... being heralded as one of the largest online extortion ... in the healthcare market, it is imperative that providers ... protect their data from this — and many other ...
(Date:6/7/2017)... Inc., (Nasdaq: NVAX ) today announced that data ... RSV F protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) ... the journal Vaccine (the data contained ... The Company previously announced top line results from ... F Vaccine with the goal of protecting infants from RSV ...
Breaking Medicine Technology: