New Data Underscores Importance of Platelet Reactivity Testing to Aid in Risk Assessment
Following Stent Placement, Low Platelet Reactivity at Time of Discharge and After 30 Days Leads to 50% Reduction in Cardiovascular Events
SAN DIEGO--(BUSINESS WIRE)--Aug 29, 2011 - Data announced today at the European Society of Cardiology (ESC) Congress in Paris and simultaneously published in Circulation1 show that stent patients exhibited a 50% reduction in cardiovascular death, heart attack and stent thrombosis over 6 months when they achieved low platelet reactivity, as measured by the Accumetrics' VerifyNow P2Y12 Test, at discharge and 30 days post-procedure. The VerifyNow P2Y12 Test is used to measure a patient's platelet reactivity and the antiplatelet effect of medications such as clopidogrel or prasugrel (Plavix® and Effient®).
"These new findings from GRAVITAS demonstrate that patients who achieve a low level of platelet reactivity do much better after a stent procedure with respect to subsequent cardiovascular events,” said Matthew J. Price, MD, of the Scripps Translational Science Institute and Scripps Clinic in La Jolla, CA. “These results further elucidate how platelet reactivity testing can help us, as physicians, assess the risk profile of our patients and guide us in determining the degree of the effect from the antiplatelet therapy that we prescribe.”
Dr. Price, principal investigator of the GRAVITAS (Gauging Responsiveness with a VerifyNow Assay-Impact on Thrombosis and Safety) trial, presented the results from the new analysis today during a State of the Art and Featured Research presentation entitled “Platelet reactivity on clopidogrel therapy and cardiovascular outcomes after percutaneous coronary intervention: a time-dependent pharmacodynamic analysis of the GRAVITAS trial” at the ESC Congress.
With this analysis, GRAVITAS is the largest multicenter randomized trial to demonstrate that reduced levels of platelet reactivity while receiving clopidogrel were independently associated with a lower risk of cardiovascular events, even after elective (non-urgent) stent procedures. Further, this marks the second recent published report2 highlighting the clinical significance of platelet reactivity measurements not only within the first 24-48 hours of a stent procedure, but also at 30 days after the procedure is completed. This demonstrates the importance of continuing to assess a patient's platelet reactivity at follow-up within the hospital or outpatient settings.
“GRAVITAS continues to position VerifyNow as a clinically relevant tool as healthcare continues to move towards the individualized treatment and risk assessment of cardiovascular patients,” said President and CEO of Accumetrics, Timothy I. Still. “With an increasingly complex array of antiplatelet medications available, and the May 2012 Plavix patent expiration in the United States, physicians are in greater need of information to determine the best treatment strategies (whether branded or generic) to provide the highest quality and most cost-effective patient care.”
The VerifyNow System is the first clinically available, rapid and easy-to-use point-of-care system for measuring platelet reactivity to multiple antiplatelet agents. Additionally, it is indicated outside the US for evaluating the risk for recurrent events in cardiovascular patients. The System is widely used in various clinical settings where antiplatelet medications are prescribed to reduce the occurrence of future thrombotic events such as heart attack and stroke.
About the GRAVITAS Study
The concept of variability in response to antiplatelet therapy has been well established. Also being demonstrated with increased frequency is that high residual platelet reactivity is associated with poor patient outcomes. Accumetrics recognized the need for a study specifically designed to explore possible treatment strategies for those patients who are poor responders to antiplatelet therapy. As a result, the GRAVITAS study is the first multi-center, placebo-controlled study to determine whether high maintenance dose of clopidogrel therapy based on the results of the company's VerifyNow P2Y12 Test reduces ischemic events post-PCI. The trial was coordinated by Scripps Advanced Clinical Trials.
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. prasugrel (Effient®) and clopidogrel (Plavix®)), and GP IIb/IIIa inhibitors (e.g. ReoPro® and Integrilin®), the VerifyNow System provides valuable information to help physicians make informed treatment decisions. For more information about the Company and its products, visit www.accumetrics.com.
The Accumetrics logo and VerifyNow are registered trademarks of Accumetrics, Inc. ReoPro is a registered trademark of Centocor, Inc. Integrilin is a registered trademark of Millennium Pharmaceuticals. Plavix is a registered trademark of sanofi-aventis. Effient is a registered trademark of Eli Lilly and Company.
1 Price, MJ. et al Circulation. 2011;124:1132-1137. (http://circ.ahajournals.org)
2 Campo, G. et al J Am Coll Cardiol. 2011;57(25):2474-83.
Posted: August 2011