On-X® Life Technologies, Inc. announced that two new PROACT abstracts further demonstrating the safety of maintaining On-X® Prosthetic Heart Valve patients on anticoagulation therapy below currently recommended guidelines are being presented at the Society for Heart Valve Disease 7th Biennial Congress in Venice, Italy, being held June 22-25, 2013.
“Serial Echocardiograms During 5-Year Follow-up After Aortic Valve Replacement in the PROACT Trial” is being presented by Marc Gerdisch, M.D., Chief of Cardiovascular and Thoracic Surgery at Franciscan St. Francis Heart Center, Indianapolis, Ind. This study was conducted to determine any relationship between echo outcomes and adverse events. Data collected at one, three and five years postoperatively show no relationship between adverse events and On-X valve size or hemodynamic characteristics. Moreover, echo evaluation up to five years showed no change in hemodynamic performance of the valve, including patients managed with lower anticoagulation.
Dennis Nichols, M.D., Cardiac Surgeon and PROACT Principle Investigator at Tacoma General Hospital, Tacoma, Wash., will present “Prevalence of Risk Factors and Low Response to Antiplatelet Medications in the Prospective Randomized On-X Anticoagulation Clinical Trail (PROACT).” This study examined the occurrence of risk factors for thromboembolism and antiplatelet response in patients to screen them for participation in the Low Risk Treatment Group of patients—those taking aspirin and clopidogrel (Plavix®)—in the PROACT trial. The non-response rate of patients for the Low Risk Treatment Group for clopidogrel was 47.1% and for aspirin was 80.4%, enabling rapid enrollment in the High Risk Patient Treatment Group of the PROACT trial.
“The PROACT trial is innovative and unique for producing the never-before-seen data related to the On-X valve implant,” said Clyde Baker, On-X LTI’s president. “Countless valve studies have reviewed simple clinical or hemodynamic results but have not examined these important data points.”
Source: BusinessWire
“Serial Echocardiograms During 5-Year Follow-up After Aortic Valve Replacement in the PROACT Trial” is being presented by Marc Gerdisch, M.D., Chief of Cardiovascular and Thoracic Surgery at Franciscan St. Francis Heart Center, Indianapolis, Ind. This study was conducted to determine any relationship between echo outcomes and adverse events. Data collected at one, three and five years postoperatively show no relationship between adverse events and On-X valve size or hemodynamic characteristics. Moreover, echo evaluation up to five years showed no change in hemodynamic performance of the valve, including patients managed with lower anticoagulation.
Dennis Nichols, M.D., Cardiac Surgeon and PROACT Principle Investigator at Tacoma General Hospital, Tacoma, Wash., will present “Prevalence of Risk Factors and Low Response to Antiplatelet Medications in the Prospective Randomized On-X Anticoagulation Clinical Trail (PROACT).” This study examined the occurrence of risk factors for thromboembolism and antiplatelet response in patients to screen them for participation in the Low Risk Treatment Group of patients—those taking aspirin and clopidogrel (Plavix®)—in the PROACT trial. The non-response rate of patients for the Low Risk Treatment Group for clopidogrel was 47.1% and for aspirin was 80.4%, enabling rapid enrollment in the High Risk Patient Treatment Group of the PROACT trial.
“The PROACT trial is innovative and unique for producing the never-before-seen data related to the On-X valve implant,” said Clyde Baker, On-X LTI’s president. “Countless valve studies have reviewed simple clinical or hemodynamic results but have not examined these important data points.”
Source: BusinessWire
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On-X® Life Technologies, Inc. announced that two new PROACT abstracts further demonstrating the safety of maintaining On-X® Prosthetic Heart Valve patien...
