New Studies Demonstrate Cost Effectiveness, Clinical Value in a Stent Population and Validation of a Therapeutic Window using the VerifyNow System
SAN DIEGO -- (BUSINESS WIRE) --
Accumetrics, Inc., developer of the market-leading VerifyNow® System, announced the presentation of a series of important data that solidifies the clinical utility of platelet reactivity testing. Real world outcomes data in high risk patients receiving stents, a cost effectiveness analysis, and validation of a therapeutic window continue to demonstrate platelet reactivity as a critical element for improving the quality of care for the millions of patients on antiplatelet therapies worldwide.
In an oral presentation, Craig I. Coleman, PharmD, Associate Professor of Pharmacy at 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. This follows his recent presentation at the 2013 annual Cardiovascular Research Technologies meeting in Washington DC, where his 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," said Dr. Coleman. "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."
Data presented from University Hospitals of Cleveland demonstrated that managing dual antiplatelet therapy (DAPT) 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.
"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 two and a half years," said Dr. Tom Lassar, Associate Director of the Adult Cardiac Catheterization Laboratory and Interventional Cardiology at University Hospitals, Case Western Reserve in Cleveland, OH. "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 association between high platelet reactivity and risk for subsequent ischemic events has been well-characterized by numerous studies. Additional analysis of ADAPT-DES, discussed at an industry expert theater, has also 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 Dr. Ajay J. Kirtane, MD, SM, Chief Academic Officer of the Center for Interventional Vascular Therapy at Columbia University Medical Center / NewYork-Presbyterian Hospital in New York City. "In over 8500 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."
The continued focus on antiplatelet therapies, including a late breaking clinical trial with phase III results from the first IV P2Y12 inhibitor to potentially come to market, coupled with numerous platelet reactivity presentations further illustrates the need for greater clarity on optimal use of antiplatelet agents in patients with cardiovascular disease.
"The developments at ACC further reinforce the importance of the VerifyNow System in clinical practice," said Timothy Still, President and CEO of Accumetrics. "We are anticipating strong growth for our market leading platelet reactivity tests that provide critical information to aid in managing the risks, benefits and cost of the chosen antiplatelet treatment strategy. This data sets a path to provide additional guidance for the clinical community to improve care for the millions of patients on antiplatelet therapies."
The VerifyNow System is currently used in over 1000 facilities in the United States and over 80 countries worldwide where antiplatelet medications are prescribed to reduce the occurrence of future thrombotic events such as heart attack and stroke.
About Accumetrics
Accumetrics is committed to advancing medical understanding of platelet function and enhancing quality of care for patients receiving antiplatelet therapies by providing industry-leading and widely accessible diagnostic tests for rapid platelet function assessment.
Accumetrics' VerifyNow System is the first rapid and easy-to-use platform to help physicians determine an individual's response to multiple antiplatelet agents. Addressing every major antiplatelet drug, including FDA-cleared products for aspirin, P2Y12 inhibitors (e.g. clopidogrel) and GP IIb/IIIa inhibitors, the VerifyNow System provides valuable information to help physicians make informed clinical decisions. 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 US for evaluating the risk for recurrent events in cardiovascular patients.
For more information about the Company and its products, visit www.accumetrics.com.
The Accumetrics logo and VerifyNow are registered trademarks of Accumetrics, Inc.
CONTACT:
Jakob Jakobsen
310-309-1003 (Office)
310-409-5351 (Cell)
jjakobsen@biosector2.com
or
Timothy I. Still
President and CEO
Accumetrics
858-404-8260
press@accumetrics.com