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:1/13/2017)... ... ... KOAMTAC ®, Inc., a leading manufacturer of Bluetooth barcode scanners and mobile ... collector at the National Retail Federation’s Big Show (NRF17) held January 15-17 in New ... need for more compact and rugged devices for collecting barcode data paired with a ...
(Date:1/13/2017)... ... ... Pahrump, Nev., used an unsavory medical experience to think of a way to improve the ... for a half year due to lazy bladder," he said. "Keeping these things on my ... to do this." , He then designed and created a prototype of the FOLEY CRADLE, ...
(Date:1/13/2017)... ... 2017 , ... People who have sensitive teeth are about as common as ... teeth. Sadly, most dental hygiene products in the market contain chemical ingredients that only ... continuing their daily oral care routine to keep their teeth white and healthy is ...
(Date:1/13/2017)... ... January 13, 2017 , ... Friday, January 13 at 5 ... game room, increasing the size of the location to 90,000 square feet. , Included ... golf course that takes customers on an educational tour of the historic route, with ...
(Date:1/13/2017)... Tennessee (PRWEB) , ... January 13, 2017 , ... MyGenetx, ... Director of Communications, and Sales Administration Specialist, Mary Taylor Smith, RD, LD, will serve ... President after serving one year as a board member and one year as Vice ...
Breaking Medicine News(10 mins):
(Date:1/13/2017)... Pharmaceuticals, Inc. ("InMed") (CSE: IN; OTCQB: IMLFF), today announced that ... Banking at Eli Lilly & Company, has been appointed to ... 28 years of senior financial and executive leadership to InMed,s ... ... significant leadership position in financial and business expertise with one ...
(Date:1/13/2017)... , January 13, 2017 Stock-Callers ... Wright Medical Group N.V. (NASDAQ: WMGI ), Varian ... Inc. (NASDAQ: MDXG ), and NuVasive Inc. (NASDAQ: ... sector which fell back to a negative finish on Thursday, ... Index falling about 0.1%, while shares of health care companies ...
(Date:1/13/2017)... January 13, 2017 According ... and Equipment Market by Method (Biochemical (Calcium Phosphate, ... Protein Production), End User - Global Forecast to ... global market from 2016 to 2021. This market ... 2021 from USD 715.4 Million in 2016, at ...
Breaking Medicine Technology: