Navigation Links
Results of the PC trial presented at TCT 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
Cardiovascular Research Foundation

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:
(Date:11/25/2015)... ... November 26, 2015 , ... ... (AUC), European Union (EU), ANDI Pan African Centres of Excellence, and public R&D ... Nairobi (UNON) for the opening of the 5th African Network for Drugs and ...
(Date:11/25/2015)... TX (PRWEB) , ... November 25, 2015 , ... For ... the companies’ “ Two Organizations, One Beat ” campaign. The partnership between the two ... services to aid in MAP International’s cause. , MAP International was founded in 1954 ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... encouraging people across the country to celebrate their sobriety and show through pictures ... post “before and after” photos this Thanksgiving with the hashtag #FacesOfGratitude on their ...
(Date:11/25/2015)... ... , ... On November 25, 2015, officials of Narconon Arrowhead , the ... of a new cutting edge recovery program that has been 50 years in the ... alcohol-addicted individuals with the purpose to free addicts from the symptoms and negative behaviors ...
(Date:11/25/2015)... Crystal Lake, IL (PRWEB) , ... November 25, 2015 , ... ... pleased to announce a recent successful appellate decision obtained by Attorneys Francisco J. Botto ... the case Adcock v. Illinois Workers’ Compensation Comm’n, 2015 IL App (2d) 130884WC. , ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... , November 26, 2015 ... the addition of the  "2016 Future ... Global Cell Surface Testing Market: Supplier ... to their offering.  --> ... of the  "2016 Future Horizons and ...
(Date:11/26/2015)... 2015 ... the  "2016 Future Horizons and Growth ... Monitoring (TDM) Market: Supplier Shares, Country ...  report to their offering.  --> ... addition of the  "2016 Future Horizons ...
(Date:11/26/2015)... November 26, 2015 ... the "Radioimmunoassay Market by Type (Reagents ... Industry, Academics, Clinical Diagnostic Labs), Application (Research, ... to 2020" report to their offering. ... the addition of the "Radioimmunoassay Market ...
Breaking Medicine Technology: