Presentations Support Accumetrics' VerifyNow System for Platelet Reactivity Testing

March 12, 2013—Accumetrics, Inc. (San Diego, CA), maker of the VerifyNow system, announced the presentation of a series of data that solidifies the clinical utility of platelet reactivity testing. Platelet reactivity as a critical element for improving the quality of care was demonstrated by real-world outcomes data in high-risk patients receiving stents, a cost effectiveness analysis, and validation of a therapeutic window. The data were presented at the 62nd annual scientific session of the American College of Cardiology (ACC) in San Francisco.

According to Accumetrics, the VerifyNow system helps determine a patient's response to multiple antiplatelet agents. The system addresses every major antiplatelet drug, including US Food and Drug Administration-approved products for aspirin, P2Y₁₂ inhibitors (eg, clopidogrel), and GP IIb/IIIa inhibitors. The VerifyNow P2Y₁₂ Test and the VerifyNow PRUTest are whole-blood assays used in the laboratory or point-of-care setting to measure the level of platelet P2Y₁₂ receptor blockade. Additionally, the VerifyNow P2Y₁₂ test is indicated outside the United States for evaluating the risk for recurrent events in cardiovascular patients.

In an oral presentation, Craig I. Coleman, PharmD, of the University of Connecticut School of Pharmacy, discussed data from his cost effectiveness analysis, which demonstrated that using a platelet reactivity-driven antiplatelet therapy treatment strategy was more cost effective than using a universal approach of generic clopidogrel in all PCI patients. At the 2013 annual Cardiovascular Research Technologies meeting in Washington, DC in February, Dr. Coleman's presentation demonstrated that a platelet reactivity-driven antiplatelet strategy is also more cost effective than a universal strategy of giving the more potent inhibitor, ticagrelor, to all PCI patients. In both analyses, the VerifyNow system was used to support the cost model.

“Antiplatelet therapy has undergone a rapid evolution following the approval of two potent and more costly agents and the recent generic availability of clopidogrel,” commented Dr. Coleman in the company's press release. “The results of our model may have significant implications on which antiplatelet agents clinicians use in PCI patients, by attempting to focus on reducing healthcare costs and hospital readmission while improving the quality of patient care.”

Also at the ACC meeting, data presented from University Hospitals of Cleveland demonstrated that managing dual-antiplatelet therapy and high on-treatment platelet reactivity using a VerifyNow P2Y₁₂ platelet reactivity testing strategy and treatment algorithms in ACS and other high-risk PCI patients led to a reduction in 30-day event rates to one which is equal to that of the facility's stable, elective PCI population.

In the company's press release, Tom Lassar, of the University Hospitals at Case Western Reserve in Cleveland, Ohio, commented, “At the Harrington Heart and Vascular Institute/University Hospitals of Cleveland, we have been ahead of the curve regarding the use of platelet reactivity testing in high-risk patients, having utilized a comprehensive platelet-function testing management program for the last 2.5 years. Incorporating platelet reactivity measurements in our decision making provides us with invaluable information to make treatment management decisions in our higher-risk PCI patients. The data reinforces our conviction that a platelet-function testing program is improving the quality of care for our PCI patients. We look forward to expanding our platelet reactivity program to other facilities in the University Hospitals System.”

The company noted that additional analysis of ADAPT-DES was discussed at the ACC meeting. The analysis validated the association between very low levels of platelet reactivity and an increased risk of bleeding complications.

“The concept of a therapeutic window for platelet reactivity has been previously postulated,” stated Ajay J. Kirtane, MD, Chief Academic Officer of the Center for Interventional Vascular Therapy at Columbia University Medical Center/New York-Presbyterian Hospital in New York City. “In over 8,500 patients, we were able to demonstrate that patients in the lowest quintile of response [PRU of 0-94] receive virtually no additional protection from ischemic events, but had a significantly higher incidence of bleeding. Recognition of this finding could potentially allow clinicians to minimize the risk of bleeding complications for patients who are on potent antiplatelet therapies."