Two PROACT abstracts, which were presented at the Society for Heart Valve Disease 7th Biennial Congress (22–25 June, Venice, Italy), further demonstrated the safety of the On-X prosthetic heart valve in patients on anticoagulation therapy below currently recommended guidelines.
“Serial echocardiograms during five-year follow-up after aortic valve replacement in the PROACT Trial” was presented by Marc Gerdisch, chief of Cardiovascular and Thoracic Surgery at Franciscan St. Francis Heart Center, Indianapolis, USA. This study was conducted to determine any relationship between echo outcomes and adverse events. Data collected at one, three and five years postoperatively showed 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, cardiac surgeon and PROACT principle investigator at Tacoma General Hospital, Tacoma, USA, presented “Prevalence of risk factors and low response to antiplatelet medications in the prospective randomized On-X anticoagulation clinicalt (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 froup 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 enrolment in the high-risk patient treatment group of the PROACT trial.